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Cephalosporins (Systemic)

This monograph includes information on the following:


Note: Products containing cefixime were withdrawn from the U.S. market by Wyeth in October 2002{26}0

1) Cefaclor
2) Cefadroxil
3) Cefamandole
4) Cefazolin
5) Cefdinir 
6) Cefditoren 
7) Cefepime
8) Cefixime *
9) Cefonicid 
10) Cefoperazone 
11) Cefotaxime
12) Cefotetan
13) Cefoxitin
14) Cefpodoxime 
15) Cefprozil
16) Ceftazidime
17) Ceftibuten 
18) Ceftizoxime
19) Ceftriaxone
20) Cefuroxime
21) Cephalexin
22) Cephalothin *
23) Cephapirin 
24) Cephradine 

VA CLASSIFICATION
Cefaclor
Primary: AM116

Cefadroxil
Primary: AM115

Cefamandole
Primary: AM116

Cefazolin
Primary: AM115

Cefdinir
Primary: AM117

Cefditoren
Primary: AM117

Cefepime
Primary: AM118

Cefixime
Primary: AM117

Cefonicid
Primary: AM116

Cefoperazone
Primary: AM117

Cefotaxime
Primary: AM117

Cefotetan
Primary: AM116

Cefoxitin
Primary: AM116

Cefpodoxime
Primary: AM117

Cefprozil
Primary: AM116

Ceftazidime
Primary: AM117

Ceftibuten
Primary: AM117

Ceftizoxime
Primary: AM117

Ceftriaxone
Primary: AM117

Cefuroxime
Primary: AM116

Cephalexin
Primary: AM115

Cephalothin
Primary: AM115

Cephapirin
Primary: AM115

Cephradine
Primary: AM115


Commonly used brand name(s): Ancef4; Apo-Cefaclor1; Apo-Cephalex21; Ceclor1; Ceclor CD1; Cedax17; Cefadyl23; Cefizox18; Cefobid10; Cefotan12; Ceftin20; Cefzil15; Ceporacin22; Ceptaz16; Claforan11; Duricef2; Fortaz16; Keflex21; Keflin22; Keftab21; Kefurox20; Kefzol4; Mandol3; Maxipime7; Mefoxin13; Monocid9; Novo-Lexin21; Nu-Cephalex21; Omnicef5; PMS-Cephalexin21; Rocephin19; Spectracef ™6; Suprax8; Tazicef16; Tazidime16; Vantin14; Velosef24; Zinacef20.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

*Not commercially available in the U.S.

Not commercially available in Canada.



Category:


Antibacterial (systemic)—

Indications

Note: Products containing cefixime were withdrawn from the U.S. market by Wyeth in October 2002{25}9

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

General considerations
Cephalosporins have been classified by “generation” based on their spectrum of antibacterial activity, providing a useful, although somewhat arbitrary, means of grouping the many cephalosporins available. Several of the newer cephalosporins with an expanded spectrum of activity do not fit into any one generation but overlap into others. These medications have been placed into the generation that most closely describes their antibacterial spectrum.

First-generation cephalosporins include cefadroxil, cefazolin, cephalexin, cephalothin, cephapirin, and cephradine.

Second-generation cephalosporins include cefaclor, cefamandole, cefonicid, cefotetan, cefoxitin, cefprozil, and cefuroxime.

Third-generation cephalosporins include cefdinir, cefditoren, cefixime, cefoperazone, cefotaxime, cefpodoxime, ceftazidime, ceftibuten, ceftizoxime, and ceftriaxone.

The fourth-generation cephalosporin is cefepime.

Selection of any antimicrobial agent usually is based on the organism(s) that is present or most likely to be present, site(s) of infection, resistance patterns, and the side effects, cost, and pharmacokinetic properties of the cephalosporin. (See also Table 1 and Table 2 .)

First-generation cephalosporins have the highest degree of activity compared with other cephalosporins against most gram-positive bacteria, including beta-lactamase–producing Staphylococcus aureus and most streptococci; exceptions include methicillin-resistant staphylococci and penicillin-resistant Streptococcus pneumoniae . No cephalosporin is effective against Enterococcus faecalis , Enterococcus faecium , or Listeria monocytogenes infections {25}8 {25}7 {25}6. Gram-negative bacteria coverage is generally limited to Escherichia coli , Klebsiella pneumoniae , and Proteus mirabilis {25}5 {25}4; cephalothin, cephapirin, and cephradine are also active, although poorly, against Haemophilus influenzae {25}3 {25}2 {25}1 {25}0. Cephalothin and cefazolin have similar spectra of activity in vitro . Although cefazolin is more active against E. coli and Klebsiella species, it is more susceptible to staphylococcal penicillinases than is cephalothin {26}9 {26}8. Cephalexin, cefadroxil, and cephradine all have very similar activities in vitro and are available only in an oral dosage form {26}7 {26}6 {26}5.

First-generation cephalosporins are used to treat bacterial endocarditis, bone and joint infections, otitis media, pneumonia, septicemia, skin and soft tissue infections, including burn wound infections, and urinary tract infections caused by susceptible bacterial organisms {26}4 {26}3 {26}2 {26}1 {26}0 {25}9. They are not effective in treating meningitis. These medications are possible alternatives to the penicillins for staphylococcal and nonenterococcal streptococcal infections, including pneumonias, bone and joint infections, and bacterial endocarditis {25}8. Cefazolin is the preferred agent for use in perioperative prophylaxis because of its longer half-life {25}7. Because first-generation cephalosporins provide inconsistent coverage against gram-negative bacilli, their empiric use as therapy for nosocomial infections is not recommended {25}6.

Second-generation cephalosporins have enhanced activity, compared with the first-generation cephalosporins, against E. coli , Klebsiella species, and P. mirabilis ; in addition, they have greater activity in vitro against a larger number of gram-negative bacteria, including H. influenzae , indole-positive Proteus , Moraxella (Branhamella) catarrhalis , Neisseria meningitidis , Neisseria gonorrhoeae , and some strains of Serratia and Enterobacter species {25}5 {25}4 {25}3 {25}2 {25}1 {25}0 {26}9. Serratia and Enterobacter species may induce beta-lactamases that inactivate the drug after a period of exposure to the cephalosporin, producing a resistance that may be expressed late; this resistance may not be detectable by disc sensitivity techniques {26}8 {26}7. The second-generation cephalosporins have slightly less or variable activity against most gram-positive cocci, and none have activity against Acinetobacter species or Pseudomonas aeruginosa {26}6.

Cefaclor and cephalexin have comparable activity in vitro against most gram-positive cocci {26}5 {26}4; however, cefaclor has better activity than cephalexin against H. influenzae , E. coli , M. catarrhalis , and P. mirabilis {26}3. Cefamandole, cefonicid, and cefuroxime all have similar activities in vitro {26}2. However, cefuroxime may be more stable against plasmid-encoded beta-lactamases (e.g., TEM-1) than is cefamandole {26}1, and cefonicid has less activity in vitro against S. aureus {26}0. Cefuroxime sodium is the only second-generation cephalosporin to penetrate into the cerebrospinal fluid (CSF) {178}9 {178}8. Cefprozil has in vitro activity that covers a broad range of organisms, including many gram-positive and gram-negative organisms that are typically covered by first-generation cephalosporins. It also has good activity against H. influenzae , M. catarrhalis , Citrobacter diversus , penicillinase-producing strains of N. gonorrhoeae , and P. mirabilis {178}7 {178}6.

Second-generation cephalosporins are used in the treatment of bone and joint infections, pneumonia, septicemia, skin and soft tissue infections, including burn wound infections, and urinary tract infections caused by susceptible bacterial organisms {178}5 {178}4 {178}3 {178}2 {178}1 {178}0 {25}9 {25}8. Cefuroxime has been used to treat meningitis caused by S. pneumoniae , H. influenzae (including ampicillin-resistant strains), and N. meningitidis , although third-generation cephalosporins have better penetration into the CSF {25}7 {25}6. Also, delayed sterilization of the CSF has been reported in children being treated with cefuroxime for bacterial meningitis {25}5 {25}4. Because cefaclor has good activity against many strains of H. influenzae , it is used in the treatment of amoxicillin-resistant otitis media and sinusitis {25}3. This is also true of cefuroxime axetil, an oral prodrug that is hydrolyzed to cefuroxime after absorption. It has been used to treat mild to moderate bronchitis, Lyme disease, otitis media, pharyngitis and tonsillitis, sinusitis, skin and soft tissue infections, uncomplicated gonococcal urethritis, and urinary tract infections {25}2 {25}1. Cefprozil is also used to treat bronchitis, otitis media, pharyngitis and tonsillitis, sinusitis, and skin and soft tissue infections {25}0.

Cefoxitin and cefotetan have the greatest activity of all the cephalosporins against anaerobes, particularly the Bacteroides fragilis group {26}9. Cefoxitin has the greatest stability in the presence of beta-lactamases produced by the B. fragilis group {26}8. Cefotetan has activity similar to that of cefoxitin against B. fragilis , but cefotetan has greater activity than cefoxitin against aerobic gram-negative bacilli in general {26}7. Most strains of Bacteroides distasonis , Bacteroides ovatus , and Bacteroides thetaiotaomicron are resistant to cefotetan in vitro {26}6. Many of the second- and third-generation cephalosporins that are active against anaerobic organisms are not effective against resistant strains of the B. fragilis group.

Cefoxitin and cefotetan are used primarily in the treatment of mixed aerobic-anaerobic bacterial infections, including aspiration pneumonia, diabetic foot infections, intraabdominal infections, and female pelvic infections {26}5. They are also used prophylactically to help prevent perioperative infections that may result from colorectal surgery and appendectomies, and in the treatment of penicillin-resistant strains of gonorrhea {26}4.

Most third-generation cephalosporins have a high degree of stability in the presence of beta-lactamases (penicillinases and cephalosporinases), and, therefore, have excellent activity against a wide spectrum of gram-negative bacteria, including penicillinase-producing strains of N. gonorrhoeae and most Enterobacteriaceae ( Citrobacter , E. coli , Enterobacter , Klebsiella , Morganella , Proteus , Providencia , and Serratia species) {26}3 {26}2 {26}1 {26}0 {178}9 {178}8 {178}7 {178}6. However, third-generation cephalosporins in general are susceptible to hydrolysis by chromosomally encoded beta-lactamases {178}5. Cefdinir has no activity against Enterobacterspecies. {178}4Cefoperazone tends to have slightly less activity against Enterobacteriaceae than the other third-generation cephalosporins because of its greater susceptibility to plasmid-encoded beta-lactamases (e.g., TEM-1, TEM-2) {178}3. Strains of P. aeruginosa , Serratia , and Enterobacter species may develop resistance to the cephalosporin after a period of exposure due to induction of beta-lactamases {178}2 {178}1 {178}0. The third-generation cephalosporins are generally not as active against gram-positive cocci as are the first- and second-generation cephalosporins {26}9. Cefotaxime, ceftizoxime, and ceftriaxone all have similar activity in vitro . Cefixime, one of three oral third-generation cephalosporins, has the most activity of all oral cephalosporins against Streptococcus pyogenes , S. pneumoniae , and all gram-negative bacilli, including beta-lactamase–producing strains of H. influenzae , M. catarrhalis , and N. gonorrhoeae {26}8 {26}7. Cefixime has little activity against staphylococci.{26}6. Cefpodoxime is also an oral third-generation cephalosporin; its spectrum of activity is very similar to that of cefixime, except that cefpodoxime also has some activity against S. aureus and Staphylococcus saprophyticus {26}5. Most species of Enterobacter , Enterococcus , Pseudomonas , Morganella , and Serratia are resistant to cefpodoxime {26}4. Ceftibuten is the oral third-generation cephalosporin that is most resistant to beta-lactamases {26}3 {26}2. It has a broad spectrum of activity in vitro against many gram-negative and selected gram-positive microorganisms, including H. influenzae , M. catarrhalis , S. pneumoniae , and S. pyogenes {26}1 {26}0.

Ceftazidime has the greatest activity of the third-generation cephalosporins against P. aeruginosa {26}9. Cefoperazone is less effective than ceftazidime, but more effective than cefotaxime, against P. aeruginosa {26}8. The other third-generation cephalosporins tend to have variable activity against this pathogen {26}7. Cefdinir and cefixime have no activity against Pseudomonas species. {26}6{26}5Cefoperazone achieves higher biliary concentrations than the other third-generation cephalosporins but has poor CSF penetration {26}4.

Cefditoren has activity against Haemophilus influenzae (including β-lactamase-producing strains), Haemophilus parainfluenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), Staphylococcus aureus (including β-lactamase-producing strains), Streptococcus pneumoniae (penicillin–susceptible strains only), and Streptococcus pyogenes.{26}3

Third-generation cephalosporins and aminoglycosides (amikacin, gentamicin, netilmicin, or tobramycin) are synergistic in vitro against certain susceptible and resistant strains of P. aeruginosa as well as Serratia marcescens and other Enterobacteriaceae, including Enterobacter cloacae , E. coli , K. pneumoniae , and P. mirabilis {26}2 {26}1 {26}0 {25}9.

Third-generation cephalosporins are used in the treatment of serious gram-negative bacterial infections, including bone and joint infections, female pelvic infections, intraabdominal infections, gram-negative pneumonia, septicemia, skin and soft tissue infections, including burn wound infections, and complicated urinary tract infections caused by susceptible organisms {25}8 {25}7. Cefotaxime, ceftazidime, ceftizoxime, and ceftriaxone are used to treat meningitis in both children and adults {25}6 {25}5 {25}4 {25}3. Single-dose cefixime, cefotaxime, cefpodoxime, ceftizoxime, and ceftriaxone have been found to be effective in the treatment of uncomplicated gonorrhea {25}2 {25}1 {25}0 {26}9 {26}8; single-dose ceftriaxone is used to treat acute otitis media {26}7; and cefuroxime axetil, [ceftriaxone], and [cefotaxime] are also effective in the treatment of Lyme disease {26}6 {26}5 {26}4.

The fourth-generation cephalosporin cefepime generally is more resistant to hydrolysis by beta-lactamases than are the third-generation cephalosporins {26}3. However, some medical experts group cefepime with the third-generation cephalosporins {26}2. Cefepime is stable against plasmid-encoded beta-lactamases (e.g., TEM-1, TEM-2, SHV-1) and is also relatively resistant to the inducible chromosomally encoded beta-lactamases {26}1 {26}0; in addition, it penetrates rapidly into gram-negative bacteria and targets multiple essential penicillin-binding proteins {26}9. These properties of cefepime make it a useful agent in treating infections caused by many Enterobacteriaceae, including Citrobacter freundii and E. cloacae , that are resistant to other cephalosporins {26}8. Although cefepime has similar activity to ceftazidime against P. aeruginosa and other gram-negative bacteria {26}7 {26}6, cefepime is less active than ceftazidime against other Pseudomonas species and Stenotrophomonas (Pseudomonas) maltophilia {26}5{26}4. The activity against gram-positive microorganisms is similar for cefepime, cefotaxime, and ceftriaxone. Cefepime is inactive against , methicillin-resistant staphylococci, penicillin-resistant pneumococci, most strains of Clostridium difficile, and most strains of enterococci such as Enterococcus faecalis{26}3 {26}2{26}1.

Cefepime is effective in the treatment of complicated intraabdominal infections, pneumonia, uncomplicated skin and soft tissue infections, complicated and uncomplicated urinary tract infections, and in the empiric treatment of febrile neutropenia {26}0. [It is also used in the treatment of bronchitis and septicemia {25}9.]

Accepted

Biliary tract infections (treatment)1—Cefazolin {25}8 is indicated in the treatment of biliary tract infections caused by susceptible organisms.

Bone and joint infections (treatment)—[ Cefaclor]1, [cefadroxil ]1 , cefamandole {25}7 {25}6, cefazolin {25}5 {25}4, [ cefixime]1 , cefonicid1 {25}3, [cefoperazone]1 , cefotaxime1 {25}2, cefotetan {25}1 {25}0, cefoxitin {26}9 {26}8, [cefpodoxime]1 , [cefprozil]1 , ceftazidime {26}7 {26}6, ceftizoxime {26}5 {26}4, ceftriaxone {26}3 {26}2, cefuroxime {26}1 {26}0, cephalexin {25}9 {25}8, [cephalothin ] {25}7, cephapirin1 {25}6, and [cephradine]1 are indicated in the treatment of bone and joint infections caused by susceptible organisms.

Bronchitis (treatment)—Cefaclor {25}5 {25}4, cefixime {25}3 {25}2, cefprozil1 {25}1, and cefuroxime axetil {25}0 {26}9 are indicated in the treatment of secondary bacterial infections of acute bronchitis caused by susceptible organisms.

Bronchitis, bacterial exacerbations (treatment)— Cefaclor1 {26}8, cefdinir{26}7, cefditoren1 {26}6 [cefepime] {26}5, cefixime1 {26}4, cefpodoxime1 {26}3, cefprozil 1 {26}2, ceftibuten1 {26}1, and cefuroxime axetil1 {26}0 are indicated in the treatment of bacterial exacerbations of chronic bronchitis caused by susceptible organisms.

Endocarditis, bacterial (treatment)—Cefazolin {178}9 {178}8, [cephalothin] , cephapirin1 {178}7, and [ cephradine]1 are indicated in the treatment of bacterial endocarditis caused by susceptible organisms.

Genitourinary tract infections (treatment)—Cefazolin {178}6 {178}5, cefoperazone 1 {178}4, cefotaxime {178}3, cephalexin {178}2 {178}1, [ cephalothin] {178}0, and cephradine 1 {27}9 are indicated in the treatment of genitourinary tract infections, including epididymitis {27}8 and prostatitis {27}7 {27}6 {27}5.

Gonorrhea, disseminated (treatment)1—Cefuroxime {27}4 is indicated in the treatment of disseminated gonorrhea.

Gonorrhea, uncomplicated (treatment)—Cefixime {27}3 {27}2, cefotaxime {27}1 {27}0, cefpodoxime1 {27}9, ceftizoxime1 {27}8, ceftriaxone {27}7 {27}6, cefuroxime {27}5 {27}4, and cefuroxime axetil {27}3 {27}2 are indicated in the treatment of uncomplicated gonorrhea.

Impetigo (treatment)1—Cefadroxil {27}1, cefuroxime axetil {27}0, and [cephalexin] {31}9 {31}8 {31}7 (Evidence rating: III) are indicated in the treatment of impetigo.

Intraabdominal infections (treatment)—Cefamandole {31}6 {31}5, cefepime {31}4 {31}3, cefoperazone1 {31}2, cefotaxime {31}1 {31}0, cefotetan {27}9 {27}8, cefoxitin {27}7 {27}6, ceftazidime {27}5 {27}4, ceftizoxime {27}3 {27}2, ceftriaxone {27}1 {27}0, and [cephalothin] {27}9 are indicated in the treatment of intraabdominal infections caused by susceptible organisms.

Lyme disease (treatment)1—[Cefotaxime], [ceftriaxone] , and cefuroxime axetil {27}8 are indicated in the treatment of Lyme disease.

Meningitis (treatment)—Cefotaxime {27}7 {27}6, ceftazidime {27}5 {27}4, ceftizoxime1 {27}3, ceftriaxone {27}2 {27}1, and cefuroxime {27}0 {27}9 are indicated in the treatment of meningitis caused by susceptible organisms.
—Although indicated, cefuroxime is no longer considered a medication of choice in the treatment of bacterial meningitis due to its poor coverage of penicillin-resistant S. pneumoniae and subsequent therapeutic failures {27}8.

Neutropenia, febrile (treatment)—Cefepime {27}7 {27}6 and [ceftazidime ]1 {27}5 are indicated for empiric treatment of febrile neutropenia.
—In patients at high risk for severe infection, including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia, antimicrobial therapy alone may not be appropriate {27}4.

Otitis media (treatment)—Cefaclor {27}3 {27}2, [cefadroxil]1 , [cefazolin]1 , cefdinir {27}1, cefixime {27}0 {27}9, cefpodoxime1 {27}8, cefprozil {27}7 {27}6, ceftibuten1 {27}5, ceftriaxone 1 {27}4, cefuroxime axetil {27}3 {27}2, cephalexin {27}1 {27}0, [cephalothin]1 , [cephapirin]1 , and cephradine1 {27}9 are indicated in the treatment of otitis media caused by susceptible organisms.

Pelvic infections, female (treatment)— Cefoperazone1 {27}8, cefotaxime {27}7 {27}6, cefotetan {27}5 {27}4, cefoxitin {27}3 {27}2, cefpodoxime1 {27}1, ceftazidime 1 {27}0, ceftizoxime1 {76}9, and ceftriaxone1 {76}8 are indicated in the treatment of female pelvic infections caused by susceptible organisms.

Perioperative infections (prophylaxis)— Cefamandole1 {76}7, cefazolin {76}6 {76}5, cefonicid1 {76}4, cefotaxime {76}3 {76}2, cefotetan {76}1 {76}0, cefoxitin {76}9 {76}8, ceftriaxone {76}7 {76}6, cefuroxime {76}5 {76}4, [ cephalothin] {76}3, and cephapirin 1 {76}2 are indicated for the prophylaxis of perioperative infections caused by susceptible organisms.

Pharyngitis, bacterial (treatment) or
Tonsillitis (treatment)—Cefaclor {76}1 {76}0, cefadroxil {31}9 {31}8, cefdinir{31}7, cefditoren1{31}6 cefixime {31}5 {31}4, cefpodoxime1 {31}3, cefprozil {31}2 {31}1, ceftibuten1 {31}0, cefuroxime axetil {156}9 {156}8, cephalexin {156}7 {156}6, and cephradine1 {156}5 are indicated in the treatment of bacterial pharyngitis and tonsillitis caused by susceptible organisms.
—Penicillin is the usual medication of choice in the treatment of streptococcal infections, including the prophylaxis of rheumatic fever. These cephalosporins are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalosporins in the prevention of subsequent rheumatic fever are not available at present. {156}4 {156}3 {156}2 {156}1 {156}0 {27}9 {27}8 {27}7 {27}6{27}5

Pneumonia, bacterial (treatment)—Cefaclor {27}4 {27}3, [cefadroxil] {27}2, cefamandole {27}1 {27}0, cefazolin {27}9 {27}8 {27}7, cefdinir{27}6, cefepime {27}5 {27}4, cefotaxime {27}3 {27}2 {27}1, cefoxitin {27}0 {27}9, cefpodoxime1 {27}8 {27}7, [cefprozil]1 {27}6, ceftazidime {27}5 {27}4, ceftriaxone1 {27}3 {27}2, cefuroxime {27}1 {27}0 {27}9, [cefuroxime axetil] {27}8 {27}7, [cephalothin] {27}6, and cephradine1 {27}5 are indicated in the treatment of bacterial pneumonia caused by susceptible organisms.

Pulmonary infections, in cystic fibrosis (treatment)—[Cefaclor] {27}4, [ cefamandole] {27}3, and ceftazidime 1 {27}2 are indicated in the treatment of pulmonary infections due to susceptible organisms in patients with cystic fibrosis.

Septicemia, bacterial (treatment)—Cefamandole {27}1 {27}0, cefazolin {140}9 {140}8, [cefepime] {140}7, cefonicid1 {140}6, cefoperazone1 {140}5, cefotaxime {140}4 {140}3, [cefotetan ]1 , cefoxitin {140}2 {140}1, ceftazidime {140}0 {153}9, ceftizoxime {153}8 {153}7, ceftriaxone {153}6 {153}5, cefuroxime1 {153}4, [cephalothin] {153}3, cephapirin1 {153}2, and [ cephradine]1 are indicated in the treatment of bacterial septicemia caused by susceptible organisms.

Sinusitis (treatment)—Cefdinir{153}1, [ cefixime] {153}0, cefprozil {27}9 {27}8, and cefuroxime axetil {27}7 {27}6 are indicated in the treatment of sinusitis due to susceptible organisms.

Skin and soft tissue infections (treatment)—Cefaclor {27}5 {27}4, cefadroxil {27}3 {27}2, cefamandole {27}1 {27}0, cefazolin {27}9 {27}8, cefdinir{27}7, cefditoren1{27}6, cefepime {27}5 {27}4, [ cefixime]1 , cefonicid1 {27}3, cefoperazone1 {27}2, cefotaxime {27}1 {27}0, cefotetan {59}9 {59}8, cefoxitin {59}7 {59}6, cefpodoxime1 {59}5, cefprozil {59}4 {59}3, ceftazidime {59}2 {59}1, ceftizoxime {59}0 {76}9, ceftriaxone {76}8 {76}7, cefuroxime {76}6 {76}5, cefuroxime axetil {76}4 {76}3, cephalexin {76}2 {76}1, [cephalothin] {76}0, cephapirin1 {78}9, and cephradine1 {78}8 are indicated in the treatment of skin and soft tissue infections caused by susceptible organisms.

Urinary tract infections, bacterial (treatment)— Cefaclor {78}7 {78}6, cefadroxil {78}5 {78}4, cefamandole {78}3 {78}2, cefazolin {78}1 {78}0, cefepime {59}9 {59}8, cefixime {59}7 {59}6, cefonicid1 {59}5, cefoperazone1 {59}4, cefotaxime {59}3 {59}2, cefotetan {59}1 {59}0, cefoxitin {76}9 {76}8, cefpodoxime1 {76}7, [cefprozil] {76}6, ceftazidime {76}5 {76}4, ceftizoxime {76}3 {76}2, ceftriaxone {76}1 {76}0, cefuroxime {78}9 {78}8, cefuroxime axetil1 {78}7, cephalexin {78}6 {78}5, [cephalothin] {78}4, cephapirin1 {78}3, and cephradine1 {78}2 are indicated in the treatment of bacterial urinary tract infections caused by susceptible organisms.

Ventriculitis (treatment)—Cefotaxime {78}1 {78}0 is indicated in the treatment of ventriculitis caused by susceptible organisms.

[Endocarditis, bacterial (prophylaxis) ]1—Cefadroxil {27}9, cefazolin {27}8, and cephalexin {27}7 are indicated in the prevention of bacterial endocarditis caused by susceptible organisms. However, cefazolin and cephalexin are not recommended for genitourinary tract procedures {27}6.

[Melioidosis (treatment)]1—Ceftazidime is indicated for the treatment of melioidosis{27}5{27}4{27}3{27}2{27}1{27}0{77}9{77}8{77}7{77}6.
—Melioidosis is an infection with Burkholderia pseudomallei, previously known as Pseudomonas pseudomallei. It is endemic in areas of southeast Asia and the northern part of Australia. Melioidosis causes acute and chronic pulmonary disease, abscesses of the skin and internal organs, meningitis, brain abscess and cerebritis, and acute fulminant rapidly fatal sepsis. Infection with B. pseudomallei has a high mortality rate. It is more common among adults, individuals with diabetes, and individuals with chronic renal disease, but it can occur in normal hosts and children. Melioidosis can reactivate years after primary infection and result in chronic or acute life-threatening disease. Melioidosis should be considered as a potential diagnosis for any patient with exposure to areas of endemicity{77}5{77}4{77}3{77}2{77}1{77}0{59}9{59}8{59}7{59}6.

[Sinusitis, amoxicillin-resistant (treatment)]1—Cefaclor is used in the treatment of sinusitis resistant to amoxicillin.

Unaccepted
None of the cephalosporins is considered to be effective against enterococci, Listeria species, chlamydia, Clostridium difficile , or methicillin-resistant Staphylococcus epidermidis or S. aureus . {59}5

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Table 1. Pharmacology/Pharmacokinetics {59}4



Drug  Bioavailability (%)  Half-life (hr)   Time to peak serum concentration (hr)  Peak serum concentration after dose  Peak urine concentration after dose 
Normal renal function   Impaired renal function  mcg/mL  Dose  mcg/mL  Dose 
First generation
 
       
Cefadroxil  95  1.5  20–25           
Oral        1.5–2  16  500 mg   1800  500 mg 
          28  1 gram     
Cefazolin    1.4–2 *  40–70           
IM          17  250 mg  2400  500 mg 
          38  500 mg  4000  1 gram 
          64  1 gram     
IV        End of infusion  188  1 gram     
Cephalexin  95  0.9–1.5  20–40           
Oral        1–2  250 mg  1000  250 mg  
          18  500 mg  2200  500 mg 
          32  1 gram  5000  1 gram 
Cephalothin    0.5–1   3–18           
IM        0.5  10  500 mg  800  500 mg 
          20  1 gram  2500  1 gram 
IV        0.25–0.5  30   1 gram     
          80–100  2 grams     
Cephapirin    0.5–0.8  1.5–2.7           
IM        0.5–1  500 mg  900  500 mg 
          16  1 gram     
IV        End of infusion  35  500 mg     
          67  1 gram     
          129  2 grams     
Cephradine  95  1.3  6–15           
Oral        1   250 mg  1600  250 mg 
          17  500 mg  3200  500 mg 
          24  1 gram  4000  1 gram 
Second generation
 
               
Cefaclor  95  0.6–0.9  2.3–2.8           
Capsules, oral suspension        0.5–1   250 mg  600  250 mg 
          13  500 mg  900  500 mg 
          23  1 gram  1900  1 gram 
Extended-release tablets        2.5–2.7  3.7 §  375 mg     
          8.2 §  500 mg     
Cefamandole    0.5–1.2  3–11            
IM        0.5–2  13  500 mg  254  500 mg 
          25  1 gram  1357  1 gram 
IV        End of infusion  139  1 gram  750  1 gram 
          240  2 grams  1380  2 grams 
          533  3 grams     
          666  4 grams     
Cefonicid    3.5–4.5  17–56           
IM        99  1 gram  385  500 mg 
IV         End of infusion  220  1 gram     
Cefotetan    3–4.6  Prolonged            
IM        1–3  71  1 gram     
          91  2 grams     
IV        End of infusion  158  1 gram  1700  1 gram 
          237  2 grams  3500  2 grams 
Cefoxitin    0.7–1.1 #  13–20           
IV        End of infusion  110  1 gram     
          244  2 grams     
Cefprozil  90–95  1.3 **  5–6           
Oral        1.5–1.7  6.1  250 mg  700  250 mg 
          10.5  500 mg  1000  500 mg 
          18.3  1 gram  2900  1 gram 
Ceftibuten    2–2.6 ††  7–22           
Oral        1.7–3 ††  10 ††  200 mg ††     
          15  400 mg     
          23  800 mg     
Cefuroxime    1.2–1.9 ‡‡  3–17           
Oral suspension        2.7–3.6  3.3   10 mg/kg     
          5.1  15 mg/kg     
          20 mg/kg     
Tablet  After food §§ (52–68)      2.2–3  125 mg     
          250 mg     
  Fasting (37)        500 mg     
          13.6  1 gram     
IM        0.75  27  750 mg  1300  750 mg 
IV        End of infusion  50  750 mg  1150  750 mg 
          100  1.5 grams  2500  1.5 grams 
Third generation
 
               
Cefdinir     1.7  3–9           
Oral capsule   16–21      1.6  300 mg     
          2.9  600 mg     
Oral suspension  25      1.8–2.2  2.3  7 mg/kg     
          3.9  14 mg/kg     
Cefditoren    1.6              
Tablets        1.5 to 3 hours  1.8 mcg per mL  200 mg      
Cefixime  40–50  3–4  6.4–11.5            
Oral        2–6  1.3  100 mg  73  100 mg 
          3.5–4.4  400 mg  164  400 mg 
Cefoperazone    1.6–2.4 ##  2.1 ##           
IM        1–2  65–75  1 gram  1000  2 grams 
          97  2 grams     
IV        End of infusion  153  1 gram  > 2200  2 grams 
          252  2 grams     
          340  3 grams     
          506  4 grams     
Cefotaxime  90–95  2.6–3           
IM        0.5  12  500 mg     
          21  1 gram     
IV          39  500 mg     
          102  1 gram     
          214  2 grams     
Cefpodoxime  50 §§  2.1–2.8  3.5–9.8           
Oral        2–3  1.4  100 mg     
          2.3  200 mg     
          3.9  400 mg     
Ceftazidime    1.4–2  13           
IM        17  500 mg  2100  500 mg 
          39  1 gram     
IV        End of infusion  42  500 mg  12,100  2 grams 
          69  1 gram     
          170  2 grams     
Ceftizoxime    1.4–1.7  30           
IM        14  500 mg     
          39  1 gram     
IV        End of infusion  60  1 gram  > 6000  1 gram 
          132  2 grams     
          220  3 grams     
Ceftriaxone                 
IM    5.8–8.7  12–24  2–3  38  500 mg  425  500 mg 
          76  1 gram  628  1 gram 
IV    4.3–4.6 ***    End of infusion  82  500 mg  526  500 mg 
          151  1 gram  995  1 gram 
          257  2 grams  2692  2 grams 
Fourth generation
 
               
Cefepime  100  14           
IM        1–2  14  500 mg     
          30  1 gram     
          57  2 grams     
IV        End of infusion  18  250 mg     
          39  500 mg     
          82  1 gram     
          164  2 grams     
* The half-life of cefazolin in neonates less than 1 week old is 4.5 to 5 hours.
 The half-life of cephalothin in neonates less than 1 week old is 1.5 to 2 hours.
 Delayed in presence of food.
§ With food. Peak serum concentration is decreased when administered under fasting conditions.
#  The half-life of cefoxitin is 5.6 hours in neonates 0 to 7 days of age; 2.5 hours in neonates 7 days to 1 month of age; and 1.7 hours in infants 1 to 3 months of age.
** In children, the half-life of cefprozil is 1.8 to 2.1 hours.
†† In children, the half-life of ceftibuten is 1.4 to 2.6 hours; the time to peak serum concentration is 2 hours; and the peak serum concentration is 13 mcg/mL after a dose of 9 mg/kg. In geriatric patients, the peak serum concentration is 17 mcg/mL after a dose of 200 mg.
‡‡ In neonates, the half-life of cefuroxime can be three to five times longer than it is in adults.
§§ Bioavailability is increased when this medication is administered with food.
## In adults, not significantly different from normal values during hemodialysis; 2.8 to 4.2 hours between hemodialysis periods; 3 to 7 hours with impaired hepatic function and/or biliary obstruction. In pediatric patients, 6 to 10 hours in low-birth-weight neonates; 4 to 6 hours in infants approximately 1 month of age; 2.2 hours in infants and children 2 months to 11 years of age.
*** The half-life of ceftriaxone in pediatric patients with meningitis after a 50- or 75-mg-per-kg dose.


Table 2. Pharmacology/Pharmacokinetics * {59}3



Drug  Protein binding (%)  Hepatic and renal biotransformation (%)  Renal excretion (% unchanged/hr)  Vol D (L/kg)
Removal by dialysis  
HD  PD 
First generation
 
       
Cefadroxil  Low
(15–20) 
No   93/24
(GF; TS) 
0.31  Yes   
Cefazolin  High (85)  No  60–89/6;
70-86/24
(GF; TS) 
0.12  Moderate  No 
Cephalexin  Low
(10–15) 
No   80/6;
90/8
(TS; GF) 
0.26  Moderate  Yes 
Cephalothin  Moderate (70)  Yes; 20–30   60–70/6
(30 as metabolite/6)
(TS) 
0.26  Moderate   
Cephapirin  Moderate
(44–50) 
Yes; 40   70/6
(TS; GF; TR) 
0.13  Slight   
Cephradine  Very low to low
(8–17) 
No  60–90/6
(TS) 
0.25  Signif  Yes 
Second generation
 
       
Cefaclor  Low (25)  No  60–85/8  0.35   Moderate  Yes 
Cefamandole  High (70–80)  No  65–85/8
(GF; TS) 
0.16  Moderate  Slight 
Cefonicid  Very high
(> 90) 
No  99/24  0.11  Slight   
Cefotetan  High to very high (78–91)   No  50–80/24  0.19  Slight  NS 
Cefoxitin   High (70–80)   Slight; 0.2–5
(inactive metabolite) 
85/6
(GF; TS) 
0.16  Moderate  NS 
Cefprozil  Moderate
(36–45) 
No   60–70/8  0.17–0.23  Moderate   
Ceftibuten  High
(65–77) 
  95/24  0.21   Yes   
Cefuroxime   Low to moderate
(33–50) 
    0.82  Moderate   
Oral     No; prodrug rapidly hydrolyzed to cefuroxime  50/12
(GF; TS) 
     
IM, IV      90/6;
96/24 
     
Third generation
 
       
Cefdinir   High (60–70)  No  12–18/ 1.7  0.35      
Cefditoren  High (88)  Pivoxil salt hydrolyzed to active cefditoren     9.3 L  30%   
Cefixime  High
(65) 
No  16/24  0.11  NS  No 
Cefoperazone   High to very high
(82–93) 
No   20–30/12 §
(GF) 
0.14–2   Slight   
Cefotaxime  Low to moderate
(30–50) 
Yes; 30–50
(active and inactive metabolites) 
50–60/6
(15–25 as active metabolite)
(GF) 
0.25–0.39   Moderate  NS 
Cefpodoxime  Low to moderate
(21–40) 
No; prodrug de-esterified to cefpodoxime  29–33/12
40/24 
0.7–1.15   Moderate   
Ceftazidime  Very low to low
(5–17) 
No  80–90/24
(GF) 
0.21–0.28   Yes  Yes 
Ceftizoxime  Low
(30) 
No  70–100/24  0.35–0.4  Moderate   
Ceftriaxone  High to very high
(83–96) 
  33–67/24  0.12–0.14 #  No  No 
Fourth generation
 
       
Cefepime  Low
(20) 
Yes; 15  80–85/12
(G/F) 
0.25 **  Yes  Slight 
* Abbreviations: GF = glomerular filtration; HD = hemodialysis; PD = peritoneal dialysis; TR = tubular reabsorption; TS = tubular secretion; NS = not significant; Signif = significant.
 In pediatric patients 6 months to 12 years of age, the Vol D = 0.5 L/kg.
 In pediatric patients 6 months to 12 years, the VolD=0.67 L/kg.
§ 75% excreted unchanged in bile; 15 to 30% (range: 10 to 36%) excreted unchanged in urine within 6 to 12 hours, primarily by glomerular filtration; up to 90% or more excreted in urine in patients with severe hepatic function impairment or biliary obstruction.
# In pediatric patients, the Vol D = 0.3 L/kg.
** In pediatric patients 2 months to 16 years of age, the Vol D = 0.33 L/kg.


Physicochemical characteristics:
Molecular weight—
    Cefaclor: 385.83 {59}2
    Cefadroxil: 381.41 {59}1
    Cefamandole nafate: 512.51 {59}0
    Cefazolin sodium: 476.5 {76}9
    Cefdinir: 395.42 {76}8
    Cefditoren: 620.73{76}7
    Cefepime: 480.57 {76}6
    Cefepime hydrochloride: 571.51 {76}5
    Cefixime: 507.51 {76}4
    Cefonicid sodium: 586.54 {76}3
    Cefoperazone sodium: 667.66 {76}2
    Cefotaxime sodium: 477.46 {76}1
    Cefotetan disodium: 619.6 {76}0
    Cefoxitin sodium: 449.44 {61}9
    Cefpodoxime proxetil: 557.61 {61}8
    Cefprozil: 407.45 {61}7
    Ceftazidime: 636.67 {61}6
    Ceftibuten: 410.43 {61}5
    Ceftizoxime sodium: 405.39 {61}4
    Ceftriaxone sodium: 661.61 {61}3
    Cefuroxime axetil: 510.4 {61}2
    Cefuroxime sodium: 446.38 {61}1
    Cephalexin: 365.41 {61}0
    Cephalothin sodium: 418.43 {78}9
    Cephapirin sodium: 445.46 {78}8
    Cephradine: 349.41 {78}7

Mechanism of action/Effect:

Bactericidal; action depends on ability to reach and bind penicillin-binding proteins located in bacterial cytoplasmic membranes. Cephalosporins inhibit bacterial septum and cell wall synthesis, probably by acylation of membrane-bound transpeptidase enzymes. This prevents cross-linkage of peptidoglycan chains, which is necessary for bacterial cell wall strength and rigidity. Also, cell division and growth are inhibited, and elongation of susceptible bacteria and lysis frequently occur. Rapidly dividing bacteria are those most susceptible to the action of cephalosporins.

Distribution:

Widely distributed throughout the body and reach therapeutic concentrations in most tissues and body fluids, including synovial, pericardial, pleural, and peritoneal fluids; bile; sputum; and urine. Also distributed into bone, the gallbladder, the myocardium, and skin and soft tissue. Most cephalosporins cross the placenta and are distributed into breast milk. {78}6

Cefoperazone and ceftriaxone reach the highest concentration in bile. Cefuroxime and ceftazidime reach the highest levels in the aqueous humor. Cefotaxime, ceftazidime, ceftizoxime, ceftriaxone, and cefuroxime are the only cephalosporins to achieve therapeutic concentrations in the cerebrospinal fluid (CSF). {78}5

Time to peak bile concentration

Cefoperazone—1 to 3 hours {78}4.

Cefditoren—1.5 to 3 hours{78}3

Bile concentration

Cefixime—Approximately 56.9 mcg per mL following a single 200-mg oral dose. {78}2

Cefoperazone—Approximately 65, 1940, and 6000 mcg per mL 0.5, 1, and 3 hours, respectively, following a 2-gram intravenous bolus dose {78}1.


Precautions to Consider

Cross-sensitivity and/or related problems

Patients allergic to one cephalosporin or cephamycin may be allergic to other cephalosporins or cephamycins also. {78}0 {77}9 {77}8 {77}7 {77}6 {77}5 {77}4 {77}3 {77}2 {77}1 {77}0 {59}9 {59}8 {59}7 {59}6 {59}5 {59}4 {59}3 {59}2 {59}1 {59}0 {76}9{76}8{76}7

Patients allergic to penicillins, penicillin derivatives, or penicillamine may be allergic to cephalosporins or cephamycins also. Cephalosporin cross-reactivity is approximately 3 to 7% in patients with a documented history of penicillin allergy {76}6. Although cephalosporins have been administered without incident to some patients with rash-type penicillin allergy, caution is recommended when cephalosporins are administered to patients with a history of penicillin anaphylaxis since anaphylaxis may also occur after cephalosporin administration {76}5{76}4.

Carcinogenicity

Cefaclor, cefadroxil, cefazolin, cefdinir, cefditoren, cefepime, cefixime, cefonicid, cefoperazone, cefotaxime, cefotetan, cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, ceftizoxime, ceftriaxone, cefuroxime, cefuroxime axetil, and cephradine—Long-term studies in animals to evaluate the carcinogenic potential of these cephalosporins have not been done. {76}3 {76}2 {76}1 {76}0 {61}9 {61}8 {61}7 {61}6 {61}5 {61}4 {61}3 {61}2 {61}1 {61}0 {78}9 {78}8 {78}7 {78}6{78}5{78}4

Mutagenicity

Cefaclor, cefadroxil, cefazolin, cefoxitin, and cephradine —Long-term studies in animals to evaluate the mutagenic potential of cefaclor, cefadroxil, cefazolin, cefoxitin, and cephradine have not been done. {78}3 {78}2 {78}1 {78}0 {28}9

Cefdinir, cefditoren, cefepime, cefixime, cefonicid, cefoperazone, cefotaxime, cefotetan, cefpodoxime, cefprozil, ceftazidime, ceftibuten, ceftizoxime, ceftriaxone, cefuroxime, and cefuroxime axetil—Studies have not shown that these cephalosporins are mutagenic. {28}8 {28}7 {28}6 {28}5 {28}4 {28}3 {28}2 {28}1 {28}0 {28}9 {28}8 {28}7 {28}6{28}5{28}4

Pregnancy/Reproduction
Fertility—

Cefamandole, cefditoren, cefoperazone, and cefotetan

Adequate and well-controlled studies in humans have not been done. {28}3 {28}2 {28}1

Beta-lactam antibacterials containing the N-methylthiotetrazole (NMTT) side chain have not been shown to cause adverse effects on fertility in rats exposed in utero , in neonatal rats (4 days of age or younger) that were treated prior to initiation of spermatogenesis, or in older rats (more than 40 days of age) after exposure for up to 6 months. Beta-lactam antibacterials containing the NMTT side chain have been shown to cause delayed maturation of the testicular germinal epithelium when given to neonatal rats during initial spermatogenic development (6 to 40 days of age), although the effect was slight in rats given 30 to 100 mg per kg of body weight (mg/kg) daily. However, in those neonatal rats given 1000 mg/kg per day (approximately 5 to 20 times the usual human dose), delayed maturation was pronounced and was associated with decreased testicular weight, arrested spermatogenesis, a reduced number of germinal cells, and vacuolation of Sertoli's cell cytoplasm. In addition, some neonatal rats given 1000 mg/kg per day from days 6 to 40 were infertile after reaching sexual maturity. {28}0 {60}9 {60}8



Other cephalosporins

Adequate and well-controlled studies in humans have not been done.

However, studies in animals have not shown that these cephalosporins cause impaired fertility. {60}7 {60}6 {60}5 {60}4 {60}3 {60}2 {60}1 {60}0 {60}9 {60}8 {60}7 {60}6 {60}5 {60}4 {60}3 {60}2 {60}1 {60}0{60}9{60}8


Pregnancy—

Cefamandole, cefoperazone, and cefotetan

Cefamandole, cefoperazone, and cefotetan cross the placenta. Adequate and well-controlled studies in humans have not been done. {60}7 {60}6 {60}5

Studies in mice, rats, and monkeys given doses of up to 10 times the usual human dose have not shown that cefamandole, cefoperazone, or cefotetan causes adverse effects in the fetus. {60}4 {60}3 {60}2

FDA Pregnancy Category B. {60}1 {60}0 {60}9



Cefdinir

Adequate and well–controlled studies in humans have not been done. {60}8

Studies in rats given oral doses up to 70 times the recommended human dose or rabbits given oral doses up to 0.7 times the human dose have not shown that cefdinir is teratogenic. However, decrease in fetal and offspring weight was observed.{60}7
FDA Pregnancy Category B. {60}6




Cefditoren and Cefoxitin

Cefoxitin crosses the placenta. Adequate and well-controlled studies in humans have not been done. {60}5

Studies in rats and mice given parenteral doses of approximately 1 to 7.5 times the maximum recommended human dose have not shown that cefoxitin is teratogenic or fetotoxic. However, a slight decrease in fetal weight was observed. Studies in rabbits have shown that cefoxitin, although not teratogenic, causes a high incidence of abortion and maternal death. {60}4

FDA Pregnancy Category B. {60}3
{60}2


Cefotaxime

Cefotaxime crosses the placenta. Adequate and well-controlled studies in humans have not been done. {60}1

Studies in rats given parenteral cefotaxime have not shown that cefotaxime is teratogenic or fetotoxic. However, a slight decrease in fetal and neonatal weight was observed. {60}0

FDA Pregnancy Category B. {60}9



Other cephalosporins

Cephalosporins cross the placenta. Adequate and well-controlled studies in humans have not been done.

However, studies in animals have not shown that these cephalosporins cause adverse effects in the fetus.

FDA Pregnancy Category B—Cefaclor {60}8, cefadroxil {60}7, cefazolin {60}6, cefepime {60}5, cefixime {60}4, cefonicid {60}3, cefpodoxime {60}2, cefprozil {60}1, ceftazidime {60}0, ceftibuten {60}9, ceftizoxime {60}8, ceftriaxone {60}7, cefuroxime {60}6, cefuroxime axetil {60}5, cephalexin {60}4, cephapirin {60}3, and cephradine {60}2.


Breast-feeding

Cefadroxil, cefditoren, cefixime, and ceftibuten—It is not known whether cefadroxil, cefixime, or ceftibuten is distributed into breast milk. However, problems in humans have not been documented to date. {60}1 {60}0 {79}9

Cefdinir—Cefdinir was not detected in human breast milk following administration of a single 600–mg dose. {79}8

Other cephalosporins—Other cephalosporins are distributed into breast milk, usually in low concentrations. However, problems in humans have not been documented to date. {79}7 {79}6 {79}5 {79}4 {79}3 {79}2 {79}1 {79}0 {60}9 {60}8 {60}7 {60}6 {60}5 {60}4 {60}3 {60}2 {60}1 {60}0 {60}9{60}8

Pediatrics

All cephalosporins—Lower metabolic and/or renal clearance of cephalosporins, with resulting prolonged half-life, has been reported in newborn infants {60}7. However, ceftriaxone has been found to have a shorter half-life in infants than it does in adults {60}6.

Cefaclor and cefazolin—Appropriate studies on the relationship of age to the effects of cefaclor or cefazolin have not been performed in premature infants and infants up to 1 month of age. However, no pediatrics-specific problems have been documented to date in children 1 month of age and older. {60}5 {60}4

Cefamandole—Appropriate studies on the relationship of age to the effects of cefamandole have not been performed in premature infants and infants up to 6 months of age. However, no pediatrics-specific problems have been documented to date in children 6 months of age and older. {60}3

Cefoperazone and cefotetan—Appropriate studies on the relationship of age to the effects of cefoperazone or cefotetan have not been performed in the pediatric population. {60}2 {60}1

Cefdinir, cefixime, cefprozil, and ceftibuten—Appropriate studies on the relationship of age to the effects of cefdinir, cefixime, cefprozil, or ceftibuten have not been performed in children up to 6 months of age. {60}0 {60}9 {60}8{60}7

Cefditoren—Safety and efficacy have not been established in patients less than 12 years of age.{60}6

Cefonicid—Cefonicid has been used in children 1 year of age and older, and no pediatrics-specific problems have been documented to date. {60}5 {60}4

Cefoxitin—In children 3 months of age and older, higher doses of cefoxitin have been associated with an increased incidence of eosinophilia and elevated aspartate aminotransferase (AST [SGOT]). {60}3

Cefpodoxime—Appropriate studies on the relationship of age to the effects of cefpodoxime have not been performed in children up to 5 months of age. {60}2

Ceftazidime L-arginine —The safety of the arginine component of ceftazidime L-arginine has not been established in children. If treatment with ceftazidime is indicated for children younger than 12 years of age, the ceftazidime sodium product should be used. {60}1

Ceftizoxime—Although studies have been done in children up to 6 months of age, ceftizoxime is not indicated for use in this age group {60}0. In children 6 months of age and older, the use of ceftizoxime has been associated with transient elevated eosinophil counts and increased concentrations of alanine aminotransferase (ALT [SGPT]), aspartate aminotransferase (AST [SGOT]), and creatine kinase (CK) {60}9.

Ceftriaxone—Because ceftriaxone is very highly bound to plasma proteins, it may be more likely than some other cephalosporins to displace bilirubin from serum albumin. Ceftriaxone should be used with caution in hyperbilirubinemic neonates, especially premature neonates. {60}8 {60}7

Cefuroxime, cefuroxime axetil, and cephapirin—Appropriate studies on the relationship of age to the effects of cefuroxime, cefuroxime axetil, and cephapirin have not been performed in children up to 3 months of age. However, no pediatrics-specific problems have been documented to date in children 3 months of age and older. {60}6 {60}5 {60}4

Cephradine—Appropriate studies on the relationship of age to the effects of cephradine have not been performed in children up to 9 months of age. However, no pediatrics-specific problems have been documented to date in children 9 months of age and older. {60}3

Other cephalosporins—Appropriate studies on the relationship of age to the effects of these cephalosporins have not been performed in the pediatric population. However, no pediatrics-specific problems have been documented to date. {60}2 {60}1 {60}0


Geriatrics


Cephalosporins have been used in the geriatric population, and no geriatrics-specific problems have been documented to date. However, elderly patients are more likely to have an age-related decrease in renal function, which may require an adjustment in dosage and/or dosing interval in patients receiving cephalosporins.


Dental

Long-term therapy with cephalosporins may allow for the overgrowth of Candida albicans , resulting in oral candidiasis. {60}9

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

» Alcohol    (concurrent use of alcohol with cefamandole, cefoperazone, or cefotetan is not recommended since these cephalosporins, because of their NMTT side chain, may inhibit the enzyme acetaldehyde dehydrogenase, resulting in accumulation of acetaldehyde in the blood {60}8 {60}7 {60}6)

    (disulfiram-like effects such as abdominal or stomach cramps, facial flushing, headache, hypotension, nausea, palpitations, shortness of breath, sweating, tachycardia, or vomiting may occur following ingestion of alcohol or administration of intravenous alcohol-containing solutions; these effects usually occur within 15 to 30 minutes following ingestion of alcohol and usually subside spontaneously over several hours {60}5 {60}4 {60}3)

    (patients should be advised not to drink alcoholic beverages, take alcohol-containing medications, or receive intravenous alcohol-containing solutions while receiving these cephalosporins and for several days after discontinuing them)


» Aminoglycoside antibiotics    (for cefuroxime: may result in nephrotoxicity{60}2)


Antacids or
Ranitidine or
Histamine H 2-receptor antagonists, other    (concurrent use of high doses of antacids or H 2 -receptor antagonists with cefpodoxime decreases absorption of cefpodoxime by 27 to 32%, and decreases peak plasma levels by 24 to 42% {60}1)

    (concurrent use of ranitidine with ceftibuten increases the plasma concentration of ceftibuten by 23% and systemic exposure by 16%; the clinical relevance of these increases is not known {60}0)

    (the extent of absorption of cefaclor and cefdinir are decreased with concurrent use of aluminum hydroxide– or magnesium-containing antacids; cefaclor should not be taken within 1 hour of taking these antacids{29}9; cefdinir should not be taken within 2 hours of taking these antacids {29}8)


» Anticoagulants, coumarin- or indandione-derivative, or
» Heparin or
» Thrombolytic agents    (concurrent use of these medications with cefamandole, cefditoren, {29}7 cefoperazone, or cefotetan may increase the risk of bleeding because of the NMTT side chain on these medications; however, critical illness, poor nutritional status, and the presence of liver disease may be more important risk factors for hypoprothrombinemia and bleeding; because all cephalosporins can inhibit vitamin K synthesis by suppressing gut flora, prophylactic vitamin K therapy is recommended when any of these medications is used for prolonged periods in malnourished or seriously ill patients; dosage adjustments of anticoagulants may be necessary during and after therapy with cefamandole, cefoperazone, or cefotetan; concurrent use of any of these three cephalosporins with thrombolytic agents may increase the risk of severe hemorrhage and is not recommended {29}6 {29}5 {29}4 {29}3)

    (an increased anticoagulant effect has been reported with concurrent use of cefaclor and oral anticoagulants {29}2)


» Diuretics, potent    (administration may adversely affect renal function thereby affecting cefuroxime elimination{29}1)


» Iron    (iron supplements, including multivitamins that contain iron, interfere with the absorption of cefdinir; cefdinir should not be taken within 2 hours of an iron supplement; iron–fortified infant formula does not significantly interfere with the absorption of cefdinir; cefdinir and iron–fortified formula can be administered concurrently {29}0)


Nephrotoxic medications (see Appendix II ) {29}9 {29}8    (cephalothin has been associated with an increased incidence of nephrotoxicity when used concurrently with aminoglycosides {29}7; this effect has rarely been seen with other commercially available cephalosporins used at appropriate doses; the potential for increased nephrotoxicity exists when cephalosporins are used with other nephrotoxic medications, such as loop diuretics, especially in patients with preexisting renal function impairment; renal function should be monitored carefully in patients receiving cephalosporins and aminoglycosides concurrently {29}6 {29}5 {29}4)


» Platelet aggregation inhibitors, other (see Appendix II )    (hypoprothrombinemia induced by large doses of salicylates and/or cephalosporins, and the gastrointestinal ulcerative or hemorrhagic potential of nonsteroidal anti-inflammatory drugs [NSAIDs], salicylates, or sulfinpyrazone may increase the risk of hemorrhage)


» Probenecid    (probenecid decreases renal tubular secretion of those cephalosporins excreted by this mechanism, resulting in increased and prolonged cephalosporin serum concentrations, prolonged elimination half-life, and increased risk of toxicity; probenecid has no effect on the excretion of cefoperazone, ceftazidime, or ceftriaxone; however, other cephalosporins and probenecid might be used concurrently in the treatment of infections, such as sexually transmitted diseases [STDs], or other infections in which high and/or prolonged antibiotic serum and tissue concentrations are required {29}3 {29}2 {29}1 {29}0 {29}9 {29}8{29}7)



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With diagnostic test results
» Coombs' (antiglobulin) tests    (a positive Coombs' reaction appears frequently in patients who receive large doses of a cephalosporin; hemolysis rarely occurs, but has been reported; test may become positive in neonates whose mothers received cephalosporins before delivery)


Copper reduction tests including
Benedict's solution or
CLINITEST® tablets or
Fehling's solution    (false positive reactions for glucose in the urine may occur following treatment with cefditoren or cefuroxime.{29}6{29}5)


Corticosteroids, urinary    (high concentrations of cefoxitin in the urine may produce false increases in the measurement of urinary 17-hydroxycorticosteroids by the Porter-Silber reaction {29}4)


Creatinine, serum and urine    (cefotetan, cefoxitin, or cephalothin may falsely elevate test values when Jaffe's reaction method is used {29}3 {29}2 {29}1; serum samples should not be obtained within 2 hours after administration {29}0)


» Ferricyanide test    (cefuroxime may cause a false negative result for blood plasma glucose ; blood plasma glucose levels should be determined by using either the glucose oxidase or hexokinase method.{29}9)


Glucose, blood    (cefprozil, cefuroxime, or cefuroxime axetil may give false-negative test results with ferricyanide tests; glucose enzymatic or hexokinase tests are recommended to determine blood glucose concentrations {29}8 {29}7 {29}6)


» Glucose, urine    (most cephalosporins [cefaclor, cefamandole, cefazolin, cefdinir, cefepime, cefixime, cefoperazone, cefotetan, cefoxitin, cefprozil, ceftazidime, cefuroxime, cefuroxime axetil, cephalexin, cephalothin, cephapirin, cephradine] may produce false-positive or falsely elevated test results with copper-reduction tests [Benedict's, Fehling's, or Clinitest]; glucose enzymatic tests, such as Clinistix and Tes-Tape, are not affected {29}5 {29}4 {29}3 {29}2 {29}1 {29}0 {29}9 {29}8 {29}7 {29}6 {29}5 {29}4 {29}3 {29}2 {29}1{29}0{29}9)


Ketones, urine    (cefdinir and cefixime may produce a false-positive reaction for ketones in the urine with tests using nitroprusside; tests using nitroferricyanide are not affected {29}8{29}7)


Protein, urine    (cefamandole may produce false-positive test results for proteinuria with acid and denaturation-precipitation tests {29}6)


» Prothrombin time (PT)    (may be prolonged; cephalosporins may inhibit vitamin K synthesis by suppressing gut flora; also, ceftazidime and cephalosporins with the NMTT side chain [cefamandole, cefoperazone, cefotetan] have been associated with an increased incidence of hypoprothrombinemia; patients who are critically ill, malnourished, or have liver function impairment may be at the highest risk of bleeding {29}5 {29}4 {29}3 {29}2)

With physiology/laboratory test values
Alanine aminotransferase (ALT [SGPT]) or
Alkaline phosphatase or
Aspartate aminotransferase (AST [SGOT]) or
Lactate dehydrogenase (LDH)    (serum values may be increased)


Bilirubin, serum or
Blood urea nitrogen (BUN) or
Creatinine, serum    (concentrations may be increased)


Carnitine or
Hematocrit    ( values may decrease during therapy)

{29}1
Cerebrospinal fluid     (for cefuroxime: persistence of positive cultures have been noted at 18 to 36 hours; clinical relevance is unknown)

{29}0
Complete blood count (CBC) or
Platelet count    (transient leukopenia, neutropenia, agranulocytosis, thrombocytopenia, eosinophilia, lymphocytosis, and thrombocytosis have been seen on rare occasions)


» Prothrombin time    (prothrombin time should be monitored in patients with hepatic or renal impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy)

{29}9
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problem exists:
» Previous allergic reaction (anaphylaxis) to penicillins, penicillin derivatives, penicillamine, or cephalosporins {29}8 {29}7 {29}6 {29}5 {29}4 {29}3 {29}2 {29}1 {29}0 {29}9 {29}8 {29}7 {29}6 {29}5 {29}4 {29}3 {29}2 {29}1 {29}0 {29}9 {29}8 {29}7 {29}6{29}5
Risk-benefit should be considered when the following medical problems exist
» Carnitine deficiency     (cefditoren increases renal excretion of carnitine)

{29}4
» Colitis, history of or
» Gastrointestinal disease, history of, especially ulcerative colitis, regional enteritis, or antibiotic-associated colitis    (cephalosporins may cause pseudomembranous colitis {29}3 {29}2 {29}1 {29}0 {29}9 {29}8 {29}7 {29}6 {29}5 {29}4 {29}3 {29}2 {29}1 {29}0 {29}9 {29}8 {29}7 {29}6 {29}5 {29}4 {29}3 {29}2 {29}1{29}0)


» Bleeding disorders, history of    (cefamandole, cefoperazone, and cefotetan, which contain the NMTT side chain, have been associated with an increased risk of bleeding; however, all cephalosporins may cause hypoprothrombinemia and, potentially, bleeding {29}9 {29}8 {29}7)


» Hepatic function impairment or
Poor nutritional state    (cefoperazone is primarily excreted in bile; may also cause elevated AST [SGOT], ALT [SGPT], and alkaline phosphatase; it is recommended that patients with both severe liver disease and significant renal disease receive a reduced dosage of cefoperazone {29}6 {29}5)

    (for cefuroxime: may be associated with a fall in prothrombin activity; exogenous Vitamin K should be administered as indicated{29}4)


Phenylketonuria    (cefprozil for oral suspension contains 28 mg of phenylalanine per 5 mL {29}3)


» Renal function impairment    (many cephalosporins are excreted renally; a reduced dosage is recommended in patients with renal function impairment receiving cefadroxil, cefamandole, cefazolin, cefdinir, cefepime, cefixime, cefonicid, cefotaxime, cefotetan, cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, ceftizoxime, cefuroxime, cephalothin, cephapirin, and cephradine {29}2 {29}1 {29}0 {29}9 {29}8 {29}7 {29}6 {29}5 {29}4 {29}3 {29}2 {29}1 {29}0 {29}9 {29}8 {29}7 {29}6 {29}5{29}4{29}3)



Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):


For all cephalosporins
Bleeding time and/or
» Prothrombin time (PT)    (determinations may be required in selected patients prior to and during therapy since hypoprothrombinemia and decreased vitamin K–dependent clotting factors may occur on rare occasion, resulting in significant hemorrhage; administration of vitamin K promptly reverses the hypoprothrombinemia, which usually occurs in elderly, debilitated, malnourished, or other seriously ill patients with deficient vitamin K stores; prophylactic daily or periodic administration of vitamin K may be required, especially in such patients receiving cefamandole, cefoperazone, or cefotetan {29}2 {29}1 {29}0)


For cefuroxime
Bacteriologic appraisal    (frequent appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months post therapy)


» Renal function evaluation    (rarely produces alterations in kidney function; evaluations are especially recommended in seriously ill patients receiving the maximum doses{29}9)


» Superinfection    (prolonged use may result in overgrowth of nonsusceptible organisms; careful observation is essential{29}8)


For antibiotic-associated pseudomembranous colitis (AAPMC)
Stool examinations    (cytotoxin assays of stool samples to document the presence of Clostridium difficile and/or its cytotoxin, which can be neutralized by Clostridium sordellii antitoxin, may be required prior to treatment in patients with AAPMC; however, C. difficile and its cytotoxin may persist following treatment with oral vancomycin, cholestyramine, bacitracin, or metronidazole, despite clinical improvement {29}7; follow-up cytotoxin assays are generally not recommended with complete clinical improvement)




Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent
    
Eosinophilia{29}6{29}5{29}4 ( black, tarry stools; chest pain; chills; cough; fever; painful or difficult urination; shortness of breath; sore throat; sores, ulcers, or white spots on lips or in mouth; swollen glands; unusual bleeding or bruising; unusual tiredness or weakness)


Incidence less frequent or rare
    
Hypersensitivity reactions ( fever; skin itching, rash, or redness ; swelling)—has occurred with many cephalosporins, but has been reported more commonly with cefazolin {29}3 {29}2
    
hypoprothrombinemia (unusual bleeding or bruising )—more frequent for cefamandole, cefoperazone, and cefotetan {29}1 {29}0 {29}9 {29}8 {29}7
    
pseudomembranous colitis ( abdominal or stomach cramps and pain, severe; abdominal tenderness; diarrhea, watery and severe, which may also be bloody; fever){29}6{29}5{29}4{29}3{29}2{29}1{29}0{29}9{29}8{29}7{29}6{29}5{29}4{29}3{29}2{29}1{29}0{29}9{29}8{29}7{29}6{29}5{29}4
    
thrombophlebitis ( pain, redness, and swelling at site of injection){29}3
    
urticaria {29}2{29}1 (hives or welts; itching; redness of skin; skin rash)


Incidence rare
    
Allergic reactions, specifically anaphylaxis (bronchospasm; hypotension)
    
Epidermal necrolysis, toxic {29}0 {29}9 {29}8 (blistering, peeling, loosening of skin; chills; cough; diarrhea; itching; joint or muscle pain; red irritated eyes; red skin lesions, often with a purple center; sore throat; sores, ulcers, or white spots in mouth or on lips; unusual tiredness or weakness)
    
erythema multiforme or Stevens-Johnson syndrome (blistering, peeling, or loosening of skin and mucous membranes, which may involve the eyes or other organ systems)
    
hearing loss —has occurred rarely in pediatric patients being treated for meningitis, but more frequently with cefuroxime {29}7 {29}6 {29}5
    
hemolytic anemia, immune, drug-induced ( unusual tiredness or weakness; yellowing of the eyes or skin)—has occurred with many cephalosporins, but has been reported more commonly with cefotetan {29}4 {29}3 {29}2 {29}1 {29}0 {30}9
    
leukopenia, neutropenia, or thrombocytopenia {30}8 {30}7 {30}6 (black, tarry stools; chest pain; chills; cough; fever ; painful or difficult urination; shortness of breath; sore throat; sores, ulcers, or white spots on lips or in mouth; swollen glands; unusual bleeding or bruising; unusual tiredness or weakness)
    
renal dysfunction (decrease in urine output or decrease in urine-concentrating ability)
    
serum sickness–like reactions (fever; joint pain; skin rash)—may be more frequent with cefaclor {30}5
    
seizures —especially with high doses and in patients with renal function impairment {30}4 {30}3

Note: Since the risk of serum sickness–like reaction to cefaclor may be as high as 0.5%, it is recommended that another cephalosporin or a similar medication, such as loracarbef, be substituted as appropriate {30}2 {30}1 {30}0.


For ceftriaxone only
    
Biliary “sludge” or pseudolithiasis (anorexia; epigastric pain; nausea and vomiting )—more likely when administered by intravenous bolus over 3 to 5 minutes{30}9{30}8{30}7{30}6


Incidence unknown
    
Agranulocytosis {30}5 {30}4 (cough or hoarseness; fever with or without chills; general feeling of tiredness or weakness; lower back or side pain; painful or difficult urination; sore throat; sores, ulcers, or white spots on lips or in mouth; unusual bleeding or bruising)
    
aplastic anemia {30}3 {30}2 (chest pain; chills; cough; fever; headache; shortness of breath; sores, ulcers, or white spots on lips or in mouth; swollen or painful glands; tightness in chest; unusual bleeding or bruising; unusual tiredness or weakness; wheezing)
    
hemorrhage {30}1 {30}0 (bleeding gums; coughing up blood; difficulty in breathing or swallowing; dizziness; headache; increased menstrual flow or vaginal bleeding; nosebleeds; paralysis; prolonged bleeding from cuts; red or dark brown urine; red or black, tarry stools; shortness of breath)
    
Hepatic dysfunction, including cholestasis {30}9 {30}8 (abdominal or stomach pain; chills; clay-colored stools; dark urine; diarrhea; dizziness; fever; headache; itching; loss of appetite; nausea; rash; unpleasant breath odor; unusual tiredness or weakness; vomiting of blood; yellow eyes or skin )
    
pancytopenia {30}7 {30}6 (high fever; chills; unexplained bleeding or bruising; bloody, black, or tarry stools; pale skin; unusual tiredness or weakness; cough; shortness of breath; sores, ulcers, or white spots on lips or in mouth; swollen glands)
    
superinfection{30}5 (fever or chills; cough or hoarseness; lower back or side pain; painful or difficult urination )
    
toxic nephropathy {30}4 {30}3 (bloody or cloudy urine; difficult or painful urination; sudden decrease in amount of urine)

For cefuroxime
    
angioedema (large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs)
{30}2



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
—less frequent with some cephalosporins    
Gastrointestinal reactions (abdominal cramps; diarrhea, mild; nausea or vomiting){30}1{30}0{30}9{30}8{30}7{30}6{30}5{30}4{30}3{30}2{30}1{30}0{30}9{30}8{30}7{30}6{30}5{30}4{30}3{30}2{30}1{30}0{30}9{30}8{30}7
    
headache {30}6{30}5{30}4
    
oral candidiasis (sore mouth or tongue)
    
stool changes {30}3 —with cefixime
    
vaginal candidiasis (vaginal itching and discharge)

Incidence less frequent or rare
    
Dizziness {30}2 {30}1
    
drug fever {30}0
    
dyspepsia {30}9 {30}8 (acid or sour stomach; belching; heartburn; indigestion; stomach discomfort, upset or pain)
    
flatulence {30}7{30}6 (bloated full feeling; excess air or gas in stomach or intestines; passing gas)
    
genital pruritus {30}5 ( itching or pain of the genital area)—with cefixime use
    
pruritus {30}4 {30}3 (itching skin )
    
skin rash {30}2 {30}1
    
vaginitis {30}0 {30}9 (itching of the vagina or genital area; pain during sexual intercourse; thick, white vaginal discharge with no odor or with a mild odor)




Those indicating possible pseudomembranous colitis and the need for medical attention if they occur after medication is discontinued
    
Abdominal or stomach cramps and pain, severe
    
abdominal tenderness
    
diarrhea, watery and severe, which may also be bloody
    
fever




Overdose
For more information on the management of overdose or unintentional ingestion, contact a poison control center (see Poison Control Center Listing ).

Treatment of overdose
To decrease absorption—Activated charcoal may aid in decreasing the absorption of cefaclor {30}8 and cephalexin; {30}7 gastric lavage may be used to decrease the absorption of cefixime. {30}6

To enhance elimination—Hemodialysis may be used to aid in the removal of cefamandole, {30}5 cefdinir, {30}4 cefepime, {30}3 cefotetan, {30}2 cefpodoxime, {30}1 cefprozil, {30}0 ceftibuten, {30}9 cefuroxime axetil, {30}8 and cephalothin; {30}7 peritoneal dialysis may also be used for cefpodoxime {30}6 and cefuroxime axetil. {30}5

There is no known specific antidote to ceftriaxone and cefixime. {30}4 Treatment is generally symptomatic and supportive. {30}3 {30}2

Supportive care—Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.


Patient Consultation

Note: Products containing cefixime were withdrawn from the U.S. market by Wyeth in October 2002

As an aid to patient consultation, refer to Advice for the Patient, Cephalosporins (Systemic).
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Allergies to penicillins, penicillin derivatives, penicillamine, or cephalosporins

Pregnancy—Cephalosporins cross the placenta





Breast-feeding—Most cephalosporins are distributed into breast milk; however, it is not known whether cefadroxil, cefditoren, cefixime, or ceftibuten is distributed into breast milk; no problems in humans have been documented





Use in children—Accumulation of cephalosporins, with resulting prolonged half-life, has been reported in newborn infants. Cefoxitin and ceftizoxime have been associated with an increased incidence of eosinophilia and elevated aspartate aminotransferase (AST [SGOT]). Ceftizoxime also has been associated with elevated alanine aminotransferase (ALT [SGPT]) and creatine kinase (CK). Ceftriaxone should be used with caution in hyperbilirubinemic neonates since it may be more likely than other cephalosporins to displace bilirubin from serum albumin

Other medications, especially alcohol, anticoagulants, heparin, other platelet aggregation inhibitors, probenecid, or thrombolytic agents
Other medical problems, especially a history of bleeding disorders; a history of gastrointestinal disease, such as colitis; hepatic function impairment; low carnitine levels; or renal function impairment

Proper use of this medication
Taking on a full or empty stomach, or taking with food if gastrointestinal irritation occurs; cefaclor extended-release tablets, cefditoren, cefpodoxime proxetil, and cefuroxime axetil oral suspension should be taken with food; ceftibuten oral suspension should be taken on an empty stomach.

Proper administration technique for oral liquids; not using after expiration date

» Compliance with full course of therapy, especially in streptococcal infections

» Importance of not missing doses and of taking at evenly spaced times

» Proper dosing
Taking as soon as possible; not taking if almost time for next dose; not doubling doses

» Proper storage

Precautions while using this medication
Checking with physician if no improvement of symptoms within a few days

» Diabetics: False-positive reactions with copper-reduction tests for urine glucose may occur

» Patients with phenylketonuria (PKU): Cefprozil oral suspension contains phenylalanine
» For severe diarrhea, checking with physician before taking any antidiarrheals; for mild diarrhea, kaolin- or attapulgite-containing, but not other, antidiarrheals may be tried; checking with physician or pharmacist if mild diarrhea continues or worsens

» Avoiding alcoholic beverages or other alcohol-containing preparations while receiving, and for several days after discontinuing, cefamandole, cefoperazone, or cefotetan

Not taking antacids within 1 hour of taking cefaclor or within 2 hours of taking cefdinir


Side/adverse effects
Signs of potential side effects, especially eosinophilia, hypersensitivity reactions, hypoprothrombinemia, pseudomembranous colitis, thrombophlebitis, urticaria, erythema multiforme or Stevens-Johnson syndrome, hearing loss, drug-induced hemolytic anemia, leukopenia, neutropenia, thrombocytopenia, renal dysfunction, serum sickness-like reactions, seizures, biliary sludge or pseudolithiasis, agranulocytosis, aplastic anemia, hemorrhage, hepatic dysfunction including cholestasis, pancytopenia, superinfection, toxic nephropathy, or angioedema


General Dosing Information
Therapy should be continued for at least 10 days in group A beta-hemolytic streptococcal infections to help prevent the occurrence of acute rheumatic fever or glomerulonephritis.

For oral dosage forms only
Most cephalosporins may be taken either on a full or empty stomach. Taking them with food may help if gastrointestinal irritation occurs. Cefaclor extended-release tablets, cefpodoxime proxetil, and cefuroxime axetil oral suspension should be taken with food {30}1. Ceftibuten oral suspension should be taken on an empty stomach, 2 hours before or 1 hour after a meal.

For parenteral dosage forms only
Perioperative (preoperative, intraoperative, and postoperative) prophylactic administration of parenteral cephalosporins usually should be discontinued within 24 hours following surgery.

For treatment of adverse effects


For antibiotic-associated pseudomembranous colitis (AAPMC):
Some patients may develop AAPMC, caused by Clostridium difficile toxin, during or following administration of cephalosporins. Mild cases may respond to discontinuation of the drug alone. Moderate to severe cases may require fluid, electrolyte, and protein replacement. {30}0

In cases not responding to the above measures or in more severe cases, oral doses of metronidazole, bacitracin, cholestyramine, or vancomycin may be used. Oral vancomycin is effective in doses of 125 to 500 mg every 6 hours for 7 to 10 days. The dose of metronidazole is 250 to 500 mg every 8 hours; cholestyramine, 4 grams four times a day; and bacitracin, 25,000 units, orally, four times a day for 5 to 10 days. Recurrences are not uncommon and may be treated with a second course of these medications. {30}9 {30}8 {30}7

Cholestyramine and colestipol resins have been shown to bind C. difficile toxin in vitro . If cholestyramine or colestipol resin is administered in conjunction with oral vancomycin, the medications should be administered several hours apart since the resins have been shown to bind oral vancomycin also. {30}6 {30}5

In addition, AAPMC may result in severe watery diarrhea, which may occur during therapy or up to several weeks after therapy is discontinued. If diarrhea occurs, administration of antiperistaltic antidiarrheals (e.g., atropine and dephenoxylate combination, loperamide, opiates) is not recommended since they may delay the removal of toxins from the colon, thereby prolonging and/or worsening damage to the colon because of toxin retention. {30}4

If hypersensitivity reactions occur, cephalosporins should be discontinued and the patient should be treated with the usual agents (antihistamines, corticosteroids, or epinephrine or other pressor amines), oxygen, and airway management, including intubation.

If seizures occur, cephalosporins should be discontinued. Anticonvulsants may be administered if clinically indicated.


CEFACLOR

Summary of Differences
Category: Second-generation cephalosporin.

Indications:


Good activity against Haemophilus influenzae .


Used for amoxicillin-resistant sinusitis.

Drug interactions:


Increased anticoagulant effect with oral anticoagulants.

Side/adverse effects:


Serum sickness–like reactions more common.


Additional Dosing Information
Renal function impairment usually does not require a reduction in dose.

Cefaclor should not be taken within 1 hour of taking antacids.

Cefaclor extended-release tablets 500 mg two times a day are bioequivalent to the capsule formulation 250 mg three times a day, but are not bioequivalent to other cefaclor formulations 500 mg three times a day.

Extended-release tablets should be taken with food. They should not be cut, crushed, or chewed.


Oral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

CEFACLOR CAPSULES USP

Usual adult and adolescent dose
[Bronchitis] or
Pharyngitis or
Pneumonia or
Skin and soft tissue infections, due to Staphylococcus aureus or Streptococcus pyogenes or
Tonsillitis or
Urinary tract infections
Oral, 250 to 500 mg every eight hours {30}3 {30}2.


Usual adult prescribing limits
2 grams per day; however, 4 grams per day have been administered {30}1.

Usual pediatric dose
This dosage form is usually not used for children. See Cefaclor for Oral Suspension USP .

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


250 mg (Rx) [Ceclor]{30}0


500 mg (Rx) [Ceclor]{157}9

Canada—


250 mg (Rx) [Apo-Cefaclor]{157}8 [Ceclor]{157}7


500 mg (Rx) [Apo-Cefaclor]{157}6 [Ceclor]{157}5

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Continue medicine for full time of treatment.


CEFACLOR FOR ORAL SUSPENSION USP

Usual adult and adolescent dose
See Cefaclor Capsules USP .

Usual adult prescribing limits
See Cefaclor Capsules USP .

Usual pediatric dose
[Bronchitis] or
Pneumonia or
Skin and soft tissue infections, due to Staphylococcus aureus or Streptococcus pyogenes or
Urinary tract infections
Infants and children 1 month of age and older: Oral, 6.7 to 13.4 mg per kg of body weight every eight hours {157}4 {157}3.

Infants up to 1 month of age: Safety and efficacy have not been established {157}2.

Otitis media or
Pharyngitis or
Tonsillitis
Infants and children 1 month of age and older: Oral, 6.7 to 13.4 mg per kg of body weight every eight hours; or 10 to 20 mg per kg of body weight every twelve hours {157}1 {157}0.

Infants up to 1 month of age: Safety and efficacy have not been established {30}9.


Usual pediatric prescribing limits
Doses of up to 60 mg per kg of body weight per day have been used. However, in older children, the maximum dose should not exceed 1.5 grams per day. {30}8

Usual geriatric dose
See Cefaclor Capsules USP .

Strength(s) usually available
U.S.—


125 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 75- and 150-mL bottles) (Rx) [Ceclor (sucrose )]{30}7[Generic]( may contain sucrose)


187 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 50- and 100-mL bottles) (Rx) [Ceclor (sucrose )]{30}6[Generic]( may contain sucrose)


250 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 75- and 150-mL bottles) (Rx) [Ceclor (sucrose )]{30}5[Generic]( may contain sucrose)


375 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 50- and 100-mL bottles) (Rx) [Ceclor (sucrose )]{30}4[Generic]( may contain sucrose)

Canada—


125 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 100- and 150-mL bottles) (Rx) [Apo-Cefaclor]{30}3 [Ceclor (sucrose)]{30}2


250 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 100- and 150-mL bottles) (Rx) [Apo-Cefaclor]{30}1 [Ceclor (sucrose)]{30}0


375 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 70- and 100-mL bottles) (Rx) [Apo-Cefaclor]{30}9 [Ceclor (sucrose)]{30}8

Packaging and storage:
Prior to reconstitution, store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Preparation of dosage form:
See manufacturer's labeling for instructions.

Stability:
After reconstitution, suspensions retain their potency for 14 days if refrigerated {30}7.

Auxiliary labeling:
   • Refrigerate.
   • Shake well.
   • Continue medicine for full time of treatment.
   • Beyond-use date.

Note: When dispensing, include a calibrated liquid-measuring device.



CEFACLOR EXTENDED-RELEASE TABLETS

Usual adult and adolescent dose
Bronchitis or
Bronchitis, bacterial exacerbations
Adults and adolescents 16 years of age and older: Oral, 500 mg every twelve hours for seven days {30}6.

Adolescents up to 16 years of age: Safety and efficacy have not been established {30}5.

Pharyngitis or
Tonsillitis
Adults and adolescents 16 years of age and older: Oral, 375 mg every twelve hours for ten days {30}4.

Adolescents up to 16 years of age: Safety and efficacy have not been established {30}3.

Skin and soft tissue infections, uncomplicated, due to Staphylococcus aureus
Adults and adolescents 16 years of age and older: Oral, 375 mg every twelve hours for seven to ten days

Adolescents up to 16 years of age: Safety and efficacy have not been established{30}2.


Usual pediatric dose
Children up to 16 years of age—Safety and efficacy have not been established {30}1.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


375 mg (Rx) [Ceclor CD (mannitol)]{30}0


500 mg (Rx) [Ceclor CD (mannitol)]{30}9

Canada—
Not commercially available.

Packaging and storage:
Store at room temperature (15 to 30 °C [59 to 86 °F]) {30}8.

Auxiliary labeling:
   • Take with food.
   • Swallow whole.
   • Continue medicine for full time of treatment.


CEFADROXIL

Summary of Differences
Category: First-generation cephalosporin.


Additional Dosing Information
May be taken with food.


Oral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

CEFADROXIL CAPSULES USP

Usual adult and adolescent dose
[Endocarditis, prophylaxis]1
Oral, 2 grams one hour prior to the start of surgery {30}7.

Pharyngitis or
Tonsillitis
Oral, 500 mg every twelve hours, or 1 gram once a day, for ten days {30}6 {30}5.

[Pneumonia]
Oral, 500 mg to 1 gram every twelve hours {30}4.

Skin and soft tissue infections
Oral, 500 mg every twelve hours; or 1 gram once a day {30}3 {30}2.

Urinary tract infections, uncomplicated
Oral, 500 mg or 1 gram every twelve hours; or 1 or 2 grams once a day {30}1 {30}0.


Note: After an initial loading dose of 1 gram, adults with impaired renal function may require a reduction in dose as follows {157}9 {157}8:

Creatinine clearance
(mL/min)/(mL/sec) 
Dose 
> 50/0.83  See Usual adult and adolescent dose
25–50/0.42–0.83   500 mg every 12 hours 
10–25/0.17–0.42  500 mg every 24 hours 
0–10/0–0.17  500 mg every 36 hours 



Usual adult prescribing limits
4 grams per day. {157}7

Usual pediatric dose
This dosage form usually is not used for children. See Cefadroxil for Oral Suspension USP .

Usual pediatric prescribing limits
2 grams for prophylaxis of endocarditis {157}6.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


500 mg (Rx) [Duricef]{157}5

Canada—


500 mg (Rx) [Duricef (lactose)]{157}4

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Continue medicine for full time of treatment.


CEFADROXIL FOR ORAL SUSPENSION USP

Usual adult and adolescent dose
See Cefadroxil Capsules USP .

Usual pediatric dose
[Endocarditis, prophylaxis]1
Oral, 50 mg per kg of body weight one hour prior to the start of surgery {157}3.

Impetigo1or
Pharyngitis or
Tonsillitis
Oral, 15 mg per kg of body weight every twelve hours, or 30 mg per kg of body weight once a day, for ten days {157}2.

Skin and soft tissue infections or
Urinary tract infections
Oral, 15 mg per kg of body weight every twelve hours {157}1.


Usual pediatric prescribing limits
See Cefadroxil Capsules USP .

Usual geriatric dose
See Cefadroxil Capsules USP .

Strength(s) usually available
U.S.—


125 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 50- and 100-mL bottles) (Rx) [Duricef (sodium benzoate) (sucrose)]{157}0


250 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 50- and 100-mL bottles) (Rx) [Duricef (sodium benzoate) (sucrose)]{30}9


500 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 50-, 75-, and 100-mL bottles) (Rx) [Duricef ( sodium benzoate) (sucrose)]{30}8

Canada—
Not commercially available.

Packaging and storage:
Prior to reconstitution, store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Preparation of dosage form:
The bottle should be tapped to loosen the powder. The indicated volume of water should be added in two portions, shaking well after each addition. {30}7


Bottle size  Total volume of water
to be added 
50 mL  34 mL 
75 mL  51 mL 
100 mL  67 mL 

Stability:
After reconstitution, suspensions retain their potency for 14 days if refrigerated {30}6.

Auxiliary labeling:
   • Refrigerate.
   • Shake well.
   • Continue medicine for full time of treatment.
   • Beyond-use date.

Note: When dispensing, include a calibrated liquid-measuring device.



CEFADROXIL TABLETS USP

Usual adult and adolescent dose
See Cefadroxil Capsules USP .

Usual adult prescribing limits
See Cefadroxil Capsules USP .

Usual pediatric dose
This dosage form usually is not used for children. See Cefadroxil for Oral Suspension USP .

Usual geriatric dose
See Cefadroxil Capsules USP .

Strength(s) usually available
U.S.—


1 gram (Rx) [Duricef]{30}5

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Continue medicine for full time of treatment.


CEFAMANDOLE

Summary of Differences
Category: Second-generation cephalosporin.

Pharmacology/pharmacokinetics: Contains N-methylthiotetrazole (NMTT) side chain.

Precautions:

• Drug interactions and/or related problems—Interacts with alcohol (disulfiram-like reaction), oral anticoagulants, and other medications that affect blood clotting.


• Laboratory value alterations—May produce false-positive test results for proteinuria with acid and denaturation-precipitation tests.


• Medical considerations/contraindications—Caution required in patients with history of bleeding problems.


• Patient monitoring—PT determinations may be required.


Side/adverse effects: May cause unusual bleeding or bruising.


Parenteral Dosage Forms

Note: The dosing and strengths of the dosage forms available are expressed in terms of cefamandole base (not the nafate salt).

CEFAMANDOLE NAFATE FOR INJECTION USP

Usual adult and adolescent dose
Perioperative prophylaxis 1
Cesarean-section patients: Intramuscular or intravenous, 1 or 2 grams (base) as soon as the umbilical cord is clamped {30}4.
Other surgery patients: Intramuscular or intravenous, 1 or 2 grams (base) one-half to one hour prior to the start of surgery; and 1 or 2 grams every six hours following surgery for twenty-four to forty-eight hours {30}3.

Pneumonia, uncomplicated or
Skin and soft tissue infections
Intramuscular or intravenous, 500 mg (base) every six hours {30}2 {30}1.

Urinary tract infections
Intramuscular or intravenous, 500 mg to 1 gram (base) every eight hours {30}0 {157}9.

For all other infections
Severe: Intramuscular or intravenous, 1 gram (base) every four to six hours {157}8 {157}7.
Life-threatening: Intramuscular or intravenous, up to 2 grams (base) every four hours {157}6 {157}5.


Note: After an initial loading dose of 1 to 2 grams (base), adults with impaired renal function may require a reduction in dose as follows {157}4 {157}3:

Creatinine clearance (mL/min)/(mL/sec)  Dose (base) 
Severe infections  Life-threatening infections (maximum) 
> 80/1.33  1–2 grams
every 6 hours 
2 grams
every 4 hours 
50–80/0.83–1.33  750 mg–1.5 grams
every 6 hours 
1.5 grams every 4 hours; or 2 grams every 6 hours 
25–50/0.42–0.83  750 mg–1.5 grams
every 8 hours 
1.5 grams every 6 hours; or 2 grams every 8 hours  
10–25/0.17–0.42   500 mg–1 gram
every 8 hours 
1 gram every 6 hours; or 1.25 grams every 8 hours 
2–10/0.03–0.17  500–750 mg
every 12 hours 
670 mg every 8 hours; or 1 gram every 12 hours 
< 2/0.03  250–500 mg
every 12 hours 
500 mg every 8 hours; or 750 mg every 12 hours 



Usual adult prescribing limits
12 grams (base) per day {157}2.

Usual pediatric dose
Perioperative prophylaxis 1
Infants and children 3 months of age and older: Intramuscular or intravenous, 12.5 to 25 mg (base) per kg of body weight one-half to one hour prior to the start of surgery; and 12.5 to 25 mg per kg of body weight every six hours following surgery for twenty-four to forty-eight hours {157}1.

Premature infants and infants up to 3 months of age: Dosage has not been established {157}0.

Mild to moderate infections
Infants and children 1 month of age and older: Intramuscular or intravenous, 8.3 to 33.3 mg (base) per kg of body weight every four to eight hours {30}9 {30}8.

Premature infants and infants up to 1 month of age: Dosage has not been established {30}7.

Severe infections
Infants and children 1 month of age and older: Intramuscular or intravenous, 25 to 50 mg (base) per kg of body weight every four to eight hours {30}6 {30}5.

Premature infants and infants up to 1 month of age: Dosage has not been established {30}4.


Usual pediatric prescribing limits
150 mg (base) per kg of body weight, or the maximum adult and adolescent dose, per day {30}3 {30}2.

Usual geriatric dose
See Usual adult and adolescent dose .

Usual geriatric prescribing limits
1.5 grams (base) every six hours for patients older than seventy-five years of age, even if serum creatinine concentrations are normal {30}1.

Strength(s) usually available
U.S.—


1 gram (base) (Rx) [Mandol (sodium 3.3 mEq per gram)]{30}0


2 grams (base) (Rx) [Mandol (sodium 3.3 mEq per gram)]{30}9

Canada—


1 gram (base) (Rx) [Mandol (sodium 3.3 mEq per gram)]{30}8


2 grams (base) (Rx) [Mandol (sodium 3.3 mEq per gram)]{30}7

Packaging and storage:
Prior to reconstitution, store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Preparation of dosage form:
To prepare initial dilution for intramuscular use, 3 mL of sterile water for injection, bacteriostatic water for injection, 0.9% sodium chloride injection, or bacteriostatic sodium chloride injection should be added to each 1-gram vial, or 6 mL of diluent should be added to each 2-gram vial {30}6. Also, up to 10 mL of 0.5 to 2% lidocaine hydrochloride injection (without epinephrine) may be added to each 1-gram vial {30}5.

To prepare initial dilution for direct intermittent intravenous use, 10 mL of sterile water for injection, 5% dextrose injection, or 0.9% sodium chloride injection should be added to each 1-gram vial, or 20 mL of diluent should be added to each 2-gram vial. The resulting solution may be administered over a 3- to 5-minute period. {30}4

To prepare initial dilution for continuous intravenous infusion, 10 mL of sterile water for injection should be added to each 1-gram vial, or 20 mL of diluent should be added to each 2-gram vial. The resulting solution may be further diluted in suitable diluents (see manufacturer's package insert). {30}3

For reconstitution of piggyback infusion bottles or pharmacy bulk vials, see manufacturer's labeling for instructions.

Stability:
After reconstitution, solutions retain their potency for 24 hours at room temperature (25 °C [77 °F]) or for 96 hours if refrigerated (5 °C [41 °F]). {30}2

If frozen immediately after reconstitution with sterile water for injection, 5% dextrose injection, or 0.9% sodium chloride injection, solutions retain their potency in the original container for 6 months at –20 °C (–4 °F). After being warmed to a maximum of 37 °C (98.6 °F), the solution should not be heated after thawing is complete. Once thawed, solutions should not be refrozen. {30}1

Solutions range in color from light yellow to amber depending on the concentration and diluent used. Solutions should not be used if they are of a different color or if they contain a precipitate. {30}0

Caution—During storage at room temperature, carbon dioxide develops inside the vial after reconstitution. This is of little or no consequence if the solution is added to sufficient quantities of intravenous fluids. However, if reconstituted cefamandole nafate is repackaged into certain types of syringes, continued production of carbon dioxide may cause leakage, or the rubber closure may be forced out of the barrel of the syringe. Therefore, syringes should be filled immediately prior to use. {30}9

Incompatibilities:
The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle. {30}8

Since cefamandole nafate contains sodium carbonate, it may be incompatible with magnesium or calcium ions (including Ringer's injection and lactated Ringer's injection). {30}7

Additional information:
Cefamandole nafate is rapidly hydrolyzed to cefamandole after initial dilution. Both compounds have microbiologic activity in vivo . {30}6

A solution containing 1 gram in 22 mL of sterile water for injection is isotonic. {30}5


CEFAZOLIN

Summary of Differences
Category: First-generation cephalosporin.


Parenteral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of uses and/or indications that are not included in U.S. product labeling.

The dosing and strengths of the dosage forms available are expressed in terms of cefazolin base (not the sodium salt).

CEFAZOLIN INJECTION USP

Usual adult and adolescent dose
[Endocarditis, prophylaxis]1
Intravenous infusion, 1 gram (base) one-half hour prior to the start of surgery {30}4.

Perioperative prophylaxis
Intravenous infusion, 1 gram (base) one-half to one hour prior to the start of surgery; 500 mg to 1 gram during surgery; and 500 mg to 1 gram every six to eight hours following surgery for up to twenty-four hours {30}3.

Pneumonia, pneumococcal
Intravenous infusion, 500 mg (base) every twelve hours {30}2.

Urinary tract infections, acute, uncomplicated
Intravenous infusion, 1 gram (base) every twelve hours {30}1.

For all other infections
Mild: Intravenous infusion, 250 to 500 mg (base) every eight hours {30}0.

Moderate to severe: Intravenous infusion, 500 mg to 1 gram (base) every six to eight hours {30}9.

Severe to life-threatening: Intravenous infusion, 1 to 1.5 grams (base) every six hours {30}8.


Note: After an initial loading dose appropriate to the severity of the infection, adults with impaired renal function may require a reduction in dose as follows {30}7:

Creatinine clearance
(mL/min)/(mL/sec) 
Dose
(base) 
³ 55/0.92  See Usual adult and
adolescent dose

35–54/0.58–0.9   Full dose every 8 hours
or less frequently 
11–34/0.18–0.57  One half the usual dose every 12 hours 
£ 10/0.17  One half the usual dose every 18–24 hours 



Usual adult prescribing limits
6 grams (base) per day; however, doses of up to 12 grams per day have been used in rare instances {30}6.

Usual pediatric dose
[Endocarditis, prophylaxis]1
Intravenous infusion, 25 mg (base) per kg of body weight one-half hour prior to the start of surgery {30}5.

For all other infections
Infants and children 1 month of age and older: Intravenous infusion, 6.25 to 25 mg (base) per kg of body weight every six hours; or 8.3 to 33.3 mg per kg of body weight every eight hours {30}4.

Neonates and infants up to 1 month of age: Intravenous infusion, 20 mg (base) per kg of body weight every eight to twelve hours {30}3.


Note: After an initial loading dose, children with impaired renal function may require a reduction in dose as follows {30}2:

Creatinine clearance
(mL/min)/(mL/sec) 
Dose
(base) 
> 70/1.17  See Usual pediatric dose
40–70/0.67–1.17   7.5–30 mg per kg of body weight every 12 hours  
20–40/0.33–0.67   3.1–12.5 mg per kg of body weight every 12 hours  
5–20/0.08–0.33   2.5–10 mg per kg of body weight every 24 hours  



Usual pediatric prescribing limits
1 gram (base) for prophylaxis of bacterial endocarditis {30}1.

Usual geriatric dose
See Usual adult and adolescent dose .

Usual geriatric prescribing limits
500 mg (base) every eight hours for patients older than seventy-five years of age, even if serum creatinine concentrations are normal {30}0.

Strength(s) usually available
U.S.—


500 mg (base) per 50 mL (Rx) [Ancef (sodium 2 mEq per gram )]{30}9


1 gram (base) per 50 mL (Rx) [Ancef (sodium 2 mEq per gram )]{30}8

Canada—
Not commercially available.

Packaging and storage:
Store between –25 and –10 °C (–13 and 14 °F), unless otherwise specified by manufacturer.

Preparation of dosage form:
The container should be thawed at room temperature (25 °C [77 °F]) or under refrigeration (5 °C [41 °F]) before administration, making sure that all ice crystals have melted. Thawing should not be forced by immersion in water baths or by microwave irradiation. {30}7

Do not use minibags in series connections. This may result in air embolism because of residual air being drawn from the primary container before administration of intravenous solution from the secondary container is complete. {30}6

Stability:
After thawing, solutions retain their potency for 48 hours at room temperature or for 30 days if refrigerated at 5 °C (41 °F). Once thawed, solutions should not be refrozen. {30}5

Do not use if the solution is cloudy or contains a precipitate. {30}4

Incompatibilities:
The admixture of cefazolin sodium injection with other medications, including pentamidine isethionate {30}3, is not recommended.

The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered at separate sites. Do not mix them in the same intravenous bag or bottle.


CEFAZOLIN FOR INJECTION USP

Usual adult and adolescent dose
[Endocarditis, prophylaxis]1
Intramuscular or intravenous, 1 gram (base) one-half hour prior to the start of surgery {30}2.

Perioperative prophylaxis
Intramuscular or intravenous, 1 gram (base) one-half to one hour prior to the start of surgery; 500 mg to 1 gram during surgery; and 500 mg to 1 gram every six to eight hours following surgery for up to twenty-four hours {30}1 {30}0 {63}.

Pneumonia, pneumococcal
Intramuscular or intravenous, 500 mg (base) every twelve hours {05} {06} {56}.

Urinary tract infections, acute, uncomplicated
Intramuscular or intravenous, 1 gram (base) every twelve hours {05} {06} {56} {63}.

For all other infections
Mild: Intramuscular or intravenous, 250 to 500 mg (base) every eight hours {05} {06}.

Moderate to severe: Intramuscular or intravenous, 500 mg to 1 gram (base) every six to eight hours {05} {06} {56} {63}.

Severe to life-threatening: Intramuscular or intravenous, 1 to 1.5 grams (base) every six hours {05} {06} {56}.


Note: Adults with renal function impairment may require a reduction in dose {05} {06} {56} {63}. See Cefazolin Injection USP .


Usual adult prescribing limits
See Cefazolin Injection USP .

Usual pediatric dose
[Endocarditis, prophylaxis]1
Intramuscular or intravenous, 25 mg (base) per kg of body weight one-half hour prior to the start of surgery {31}.

For all other infections
Infants and children 1 month of age and older: Intramuscular or intravenous, 6.25 to 25 mg (base) per kg of body weight every six hours; or 8.3 to 33.3 mg per kg of body weight every eight hours {05}.

Neonates and infants up to 1 month of age: Intravenous infusion, 20 mg (base) per kg of body weight every eight to twelve hours {140}.


Note: Children with renal function impairment may require a reduction in dose {05} {06}. See Cefazolin Injection USP .


Usual pediatric prescribing limits
See Cefazolin Injection USP .

Usual geriatric dose
See Cefazolin Injection USP .

Usual geriatric prescribing limits
See Cefazolin Injection USP .

Strength(s) usually available
U.S.—


500 mg (base) (may be available in ADD-Vantage® vials) (Rx) [Ancef (sodium 46 mg per gram)]{05} [Kefzol (sodium 46 mg per gram)]{06}[Generic]


1 gram (base) (may be available in ADD-Vantage® vials) (Rx) [Ancef (sodium 46 mg per gram)]{05} [Kefzol (sodium 46 mg per gram)]{06}[Generic]


5 grams (base) (Rx) [Ancef (sodium 46 mg per gram)]{05}


10 grams (base) (Rx) [Ancef (sodium 46 mg per gram)]{05} [Kefzol (sodium 46 mg per gram)]{06}[Generic]

Canada—


50 mg (base) (may be available in Add-Vantage® vials) (Rx) [Kefzol]{56}


500 mg (base) (may be available in ADD-Vantage® vials) (Rx) [Ancef (sodium 46 mg per gram)]{63} [Kefzol]{56}[Generic]


1 gram (base) (also may be available in ADD-Vantage® vials) (Rx) [Ancef (sodium 46 mg per gram)]{63} [Kefzol]{56}[Generic]


10 grams (base) (Rx) [Ancef (sodium 46 mg per gram)]{63} [Kefzol]{56}[Generic]

Packaging and storage:
Prior to reconstitution, store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Preparation of dosage form:
To prepare initial dilution for intramuscular use, 2 mL of sterile water for injection should be added to each 500-mg vial, or 2.5 mL of diluent should be added to each 1-gram vial. {05} {06}

To prepare initial dilution for intravenous use, 2 mL of sterile water for injection should be added to each 500-mg vial, or 2.5 mL of diluent should be added to each 1-gram vial. For direct intravenous use further dilute with approximately 5 to 10 mL of sterile water for injection (see manufacturer's labeling instructions), and the resulting solution may be administered over a 3- to 5-minute period. For intermittent or continuous intravenous use, the solution may be further diluted in 50 to 100 mL of suitable diluent (see manufacturer's package insert). {05} {06}

For reconstitution of piggyback infusion bottles, pharmacy bulk vials, and dual-compartment vials, see manufacturer's labeling for instructions.

Stability:
Prior to reconstitution, powders in their original containers are stable for up to 24 months. {63}

After reconstitution, solutions retain their potency for 24 hours at room temperature or for 10 days if refrigerated (5 °C [41 °F]). {05} {06}

Reconstituted solutions may range in color from pale yellow to yellow without a change in potency. {05} {06}

Incompatibilities:
The admixture of cefazolin with other medications, including pentamidine isethionate {82}, is not recommended.

The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered at separate sites. Do not mix them in the same intravenous bag or bottle.


CEFDINIR

Summary of Differences
Category: Third-generation cephalosporin. One of three oral third-generation cephalosporins.

Laboratory values: May produce false-positive reaction for ketones in urine with tests using nitroprusside.


Additional Dosing Information
Iron supplements including iron containing multivitamins decrease the absorption of cefdinir. Administration of cefdinir should be taken at least 2 hours before or after the iron supplement. Iron-fortified infant formula can be administered concurrently with cefdinir because it does not significantly interfere with the absorption of cefdinir. {160}

The capsule and oral suspension dosage form may be taken with or without food. {160}


Oral Dosage Forms

CEFDINIR FOR ORAL SUSPENSION

Usual adult and adolescent dose
Chronic bronchitis, acute exacerbations
Pharyngitis/tonsillitis or
Sinusitis, acute maxillary
Oral, 300 mg every 12 hours; or 600 mg every 24 hours. Duration of treatment is 10 days except for pharyngitis/tonsillitis when 300 mg every 12 hours is taken then the duration is 5 to 10 days. {160}

Pneumonia, community–acquired or
Skin and skin structure infections, uncomplicated
Oral, 300 mg every 12 hours. Treatment duration is 10 days.{160}


Note: Patients with renal function impairment require a dose reduction. For adults with a creatinine clearance of < 30 mL/min the dose of cefdinir should be 300 mg once daily.{160} In patients maintained on chronic hemodialysis, the recommended dose is 300 mg every other day with a supplemental dose (300 mg) at the conclusion of each hemodialysis session. {160}


Usual pediatric dose
Otitis media, acute bacterial or
Pharyngitis/tonsillitis or
Sinusitis, acute maxillary
Infants and children 6 months to 12 years of age: Oral, 7 mg per kg of body weight every twelve hours; or 14 mg per kg of body weight once a day. Duration of treatment is 10 days except for otitis media and pharyngitis/tonsillitis when doses of 7 mg per kg of body weight every 12 hours is administered then the duration is 5 to 10 days.{160}

Infants up to 6 months of age: Dosage has not been established.{160}

Skin and skin structure infections, uncomplicated
Infants and children 6 months to 12 years of age: Oral, 7 mg per kg of body weight every 12 hours for 10 days.{160}

Infants up to 6 months of age: Dosage has not been established. {160}


Note: Patients with renal function impairment require a dose reduction. For pediatric patients with a creatinine clearance of < 30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg per kg of body weight (up to 300 mg) given once daily.{160} In pediatric patients maintained on chronic hemodialysis, the recommended dose is 7 mg per kg body weight every other day and a supplemental dose (7 mg per kg of body weight) at the conclusion of each hemodialysis session. {160}


Usual pediatric prescribing limits
600 mg per day. {160}

Usual geriatric dose
SeeUsual adult and adolescent dose.

Strength(s) usually available
U.S.—


125 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 60– and 100–mL bottles) (Rx) [Omnicef ( sucrose, NF 2.86 gm per 5 mL) (citric acid, USP ) (sodium citrate, USP) ( sodium benzoate, NF) (xanthan gum, NF) (guar gum, NF) (artificial strawberry and cream flavors) (silicon dioxide, NF) (magnesium stearate, NF)]{160}

Packaging and storage:
Prior to reconstitution, store at 25° C (77° F); excursions permitted to 15°–30° C (59°–86° F).{160}

Preparation of dosage form:
The bottle should be tapped to loosen the powder. The indicated volume of water should be added in two portions, shaking well after each addition {160}.


Final Concentration  Bottle size  Total volume of water
to be added 
125 mg/5 mL  60 mL   38 mL 
125 mg/5 mL  100 mL  63 mL 

Stability:
After reconstitution, the suspension can be stored at room temperature ( 25° C [77° F]){160}. The container should be shaken well before each administration. The suspension may be used for 10 days, after which any unused portion must be discarded. {160}

Auxiliary labeling:
   • Shake well.
   • Continue medicine for full time of treatment.
   • Beyond-use date.

Note: When dispensing, include a calibrated liquid-measuring device.



CEFDINIR CAPSULES

Usual adult and adolescent dose
See Cefdinir for Oral Suspension.

Usual pediatric dose
See Cefdinir for Oral Suspension.

Usual geriatric dose
See Cefdinir for Oral Suspension.

Strength(s) usually available
U.S.—


300 mg (Rx) [Omnicef (carboxymethylcellulose calcium, NF) (polyoxyl 40 stearate, NF) (magnesium stearate, NF) (silicon dioxide, NF)]{160}

Packaging and storage:
Store the capsules at 25° C (77° F); excursions permitted to 15°–30° C (59°–86° F).{160}

Auxiliary labeling:
   • Continue medicine for full time of treatment.


CEFDITOREN

Summary of Differences
Category: Third-generation cephalosporin.


Oral Dosage Form

CEFDITOREN TABLETS

Usual adult and adolescent dose
Bacterial exacerbation of chronic bronchitis, acute
Oral, 400 mg twice daily for ten days

Pharyngitis or
Skin and skin structure infections, uncomplicated or
Tonsillitis
Oral, 200 mg twice daily for ten days


Usual pediatric dose
Safety and efficacy have not been established in children less than 12 years of age

Usual geriatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


200 mg [Spectracef ™ (croscarmellose sodium) ( sodium caseinate) (D-mannitol) ( magnesium stearate) (sodium triphosphate) (hydroxypropyl methylcellulose) ( hydroxypropyl cellulose) (titanium dioxide) ( polyethylene glycol) (carnauba wax) (FD&C Blue No. 1) (D&C Red No. 27) (shellac) (and propylene glycol)]


CEFEPIME

Summary of Differences
Category: Fourth-generation cephalosporin.


Additional Dosing Information
Cefepime should be administered over a period of 30 minutes.


Parenteral Dosage Forms

Note: Bracketed uses is the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

The dosing and strengths of the dosage form available are expressed in terms of cefepime base (not the hydrochloride salt).

CEFEPIME HYDROCHLORIDE FOR INJECTION

Usual adult and adolescent dose
intraabdominal infections, complicated
Intravenous, 2 grams (base), in combination with metronidazole, every twelve hours for seven to ten days {07}.

[Septicemia]or
Skin and soft tissue infections, uncomplicated, moderate to severe or
Urinary tract infections, severe
Intravenous, 2 grams (base) every twelve hours for ten days {07} {64}.

Neutropenia, febrile
Intravenous, 2 grams (base) every eight hours for seven days or until resolution of neutropenia {07}.

Note: In patients whose fever resolves but who remain neutropenic for more than seven days, the need for continued antimicrobial therapy should be re-evaluated frequently {07}.


Pneumonia, moderate to severe
Intravenous, 1 to 2 grams (base) every twelve hours for ten days {07} {64}.

Urinary tract infections, mild to moderate
Intramuscular or intravenous, 500 mg to 1 gram (base) every twelve hours for seven to ten days {07} {64}.


Note: After an initial loading dose equal to that of patients with normal renal function, patients with renal function impairment may require a reduction in dose as follows {07} {64}:

Creatinine clearance
(mL/min)/(mL/sec) 
Recommended dosing schedule for normal renal function, based on severity of infection 
> 60/1  500 mg every 12 hours   1 gram every 12 hours   2 grams every 12 hours  2 grams every 8 hours 
  Recommended maintenance dosing schedule for renal function impairment, based on severity of infection  
30–60/0.5–1  500 mg every 24 hours  1 gram every 24 hours  2 grams every 24 hours  2 grams every 12 hours 
11–29/0.18–0.49  500 mg every 24 hours  500 mg every 24 hours  1 gram every 24 hours  2 grams every 24 hours 
< 11/0.18  250 mg every 24 hours  250 mg every 24 hours  500 mg every 24 hours  1 gram every 24 hours 
Hemodialysis patients  Repeat the initial dose at the completion of each dialysis session.  
Peritoneal dialysis patients  Administer normally recommended dose at 48-hour intervals. 



Usual pediatric dose
Pneumonia, moderate to severe or
Skin and skin structure infection, moderate to severe, uncomplicated or—
Urinary tract infection, mild or moderate, uncomplicated or complicated
Infants and children 2 months to 16 years of age (up to 40 kg of body weight): Intravenous, 50 mg per kg of body weight every 12 hours for 10 days (7 to 10 days for urinary tract infection){161}.
Urinary tract infection, severe, uncomplicated or complicated
Infants and children 2 months to 16 years of age (up to 40 kg of body weight): Intravenous or intramuscular, 50 mg per kg of body weight every 12 hours for 7 to 10 days{161}.


Note: Intramuscular route of administration is indicated only for mild to moderate, uncomplicated or complicated urinary tract infections due to Escherichia coli in the event that intramuscular administration is determined to be the more appropriate drug administration route {161}.

Febrile neutropenia, empiric therapy
Infants and children 2 months to 16 years of age (up to 40 kg of body weight): Intravenous, 50 mg per kg of body weight every 8 hours for 7 days or until resolution of neutropenia {161}.
Note: In patients whose fever resolves but who remain neutropenic for more than seven days, the need for continued antimicrobial therapy should be re-evaluated frequently {161}.





Usual pediatric prescribing limits
The maximum pediatric dose should not exceed the dose recommended for adults{161}.

Usual geriatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


500 mg (base) (Rx) [Maxipime (L-arginine 725 mg per gram)]{161}


1 gram (base) (also available in ADD-Vantage® vials) (Rx) [Maxipime (L-arginine 725 mg per gram)]{161}


2 grams (base) (also available in ADD-Vantage® vials) (Rx) [Maxipime (L-arginine 725 mg per gram)]{161}

Canada—


500 mg (base) (Rx) [Maxipime (L-arginine 725 mg per gram)]{64}


1 gram (base) (Rx) [Maxipime (L-arginine 725 mg per gram)]{64}


2 grams (base) (Rx) [Maxipime (L-arginine 725 mg per gram)]{64}

Packaging and storage:
Prior to reconstitution, store between 2 and 25 °C (36 and 77 °F). Protect from light. {161}

Preparation of dosage form:
To prepare initial dilution for intramuscular use, 1.3 mL of sterile water for injection, 0.9% sodium chloride injection, 5% dextrose injection, 0.5% or 1% lidocaine hydrochloride, or sterile bacteriostatic water for injection containing either parabens or benzyl alcohol should be added to each 500-mg vial, or 2.4 mL of diluent should be added to each 1-gram vial. {161}

To prepare initial dilution for intravenous administration, 5 mL of suitable diluent (see manufacturer's labeling instructions) should be added to each 500-mg vial, or 10 mL of diluent should be added to each 1- or 2-gram vial. The resulting solution should be further diluted in 50 to 100 mL of a suitable diluent and administered over a period of 30 minutes. {161}

For reconstitution of piggyback infusion bottles and ADD-Vantage® vials, dilute in 50 or 100 mL of suitable diluent (see manufacturer's labeling instructions), and administer over a period of 30 minutes. {161}

Stability:
After reconstitution, intramuscular solutions, intravenous solutions at concentrations from 1 to 40 mg per mL, and ADD-Vantage® vials at concentrations from 10 to 20 mg per mL retain their potency for up to 24 hours at room temperature (20 to 25 °C [68 to 77 °F]) or for 7 days if refrigerated (2 to 8 °C [36 to 46 °F]). {161}

Solutions range in color from colorless to amber. {161}

Incompatibilities:
Cefepime should not be added to ampicillin solutions of a strength greater than 40 mg per mL, or to aminophylline, gentamicin, metronidazole, netilmicin, tobramycin, or vancomycin solutions. If these medications are administered concurrently with cefepime, they should be administered at separate sites. {161}


CEFIXIME

Summary of Differences
Category: Third-generation cephalosporin. One of three oral third-generation cephalosporins.

Laboratory values: May produce false-positive reaction for ketones in urine with tests using nitroprusside.


Additional Dosing Information
The oral suspension form of cefixime results in higher peak blood concentrations than the tablet when administered at the same dose. Therefore, the tablet should not be substituted for the oral suspension in the treatment of otitis media.


Oral Dosage Forms

CEFIXIME FOR ORAL SUSPENSION USP

Usual adult and adolescent dose
Bronchitis or
Bronchitis, bacterial exacerbations1 or
Pharyngitis or
Tonsillitis or
Urinary tract infections, uncomplicated
Oral, 200 mg every twelve hours; or 400 mg once a day {08} {65}.

Gonorrhea, cervical or urethral, uncomplicated
Oral, 400 mg as a single dose {08} {65}.


Note: Patients with renal function impairment may require a reduction in dose as follows {08}:

Creatinine clearance
(mL/min)/(mL/sec) 
Dose 
> 60/1  See Usual adult and adolescent dose
21–60/0.35–1 or hemodialysis patients  75% of standard dosage at standard dosing interval
< 20/0.33 or CAPD patients   50% of standard dosage at standard dosing interval



Usual pediatric dose
Bronchitis or
Bronchitis, bacterial exacerbations1 or
Otitis media or
Pharyngitis or
Tonsillitis or
Urinary tract infections, uncomplicated
Children 50 kg of body weight and over: See Usual adult and adolescent dose .

Infants and children 6 months to 12 years of age and up to 50 kg of body weight: Oral, 4 mg per kg of body weight every twelve hours; or 8 mg per kg of body weight once a day {08} {65}.

Infants up to 6 months of age: Dosage has not been established {08} {65}.


Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—
Not commercially available

Note: Products containing cefixime were withdrawn from the U.S. market by Wyeth in October 2002 {179}


Canada—


100 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 50-, 75-, and 100-mL bottles) (Rx) [Suprax ( sodium benzoate) (sucrose)]{65}{181}

Packaging and storage:
Prior to reconstitution, store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Preparation of dosage form:
The bottle should be tapped to loosen the powder. The indicated volume of water should be added in two portions, shaking well after each addition {08}.


Bottle size  Total volume of water
to be added 
50 mL  36 mL 
75 mL  52 mL 
100 mL  69 mL 

Stability:
After reconstitution, suspension retains its potency for 14 days at room temperature or if refrigerated {08}.

Auxiliary labeling:
   • Does not require refrigeration.
   • Shake well.
   • Continue medicine for full time of treatment.
   • Beyond-use date.

Note: When dispensing, include a calibrated liquid-measuring device.



CEFIXIME TABLETS USP

Usual adult and adolescent dose
See Cefixime for Oral Suspension USP .

Usual pediatric dose
See Cefixime for Oral Suspension USP .

Note: Otitis media should be treated with cefixime for oral suspension since the suspension results in higher peak blood levels than the tablet when administered at the same dose {08} {65}.


Usual geriatric dose
See Cefixime for Oral Suspension USP .

Strength(s) usually available
U.S.—
Not commercially available

Note: Products containing cefixime were withdrawn from the U.S. market by Wyeth in October 2002 {179}


Canada—


400 mg (Rx) [Suprax (scored)]{65}{181}

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Continue medicine for full time of treatment.


CEFONICID

Summary of Differences
Category: Second-generation cephalosporin.


Additional Dosing Information
Intramuscular doses of 2 grams should be administered as divided doses in different sites.


Parenteral Dosage Forms

Note: The dosing and strengths of the dosage forms available are expressed in terms of cefonicid base (not the sodium salt).

CEFONICID INJECTION USP

Usual adult and adolescent dose
Perioperative prophylaxis 1
Cesarean-section patients: Intramuscular or intravenous, 1 gram (base) as soon as the umbilical cord is clamped {09}.

Other surgical patients: Intramuscular or intravenous, 1 gram (base) one hour prior to the start of surgery {09}.

Urinary tract infections, uncomplicated1
Intramuscular or intravenous, 500 mg (base) every twenty-four hours {09}.

For all other infections 1
Mild to moderate: Intramuscular or intravenous, 1 gram (base) every twenty-four hours {09}.

Severe to life-threatening: Intramuscular or intravenous, 2 grams (base) every twenty-four hours {09}.


Note: After an initial loading dose of 7.5 mg (base) per kg of body weight, adults with impaired renal function may require a reduction in dose as follows {09}:

Creatinine clearance (mL/min)/(mL/sec)  Dose (base) 
Mild to moderate infections  Severe infections 
³ 80/1.33  See Usual adult and
adolescent dose

See Usual adult and
adolescent dose

60–79/1–1.31  10 mg/kg
every 24 hours 
25 mg/kg
every 24 hours 
40–59/0.67–0.98  8 mg/kg
every 24 hours 
20 mg/kg
every 24 hours 
20–39/0.33–0.65  4 mg/kg
every 24 hours 
15 mg/kg
every 24 hours 
10–19/0.17–0.32  4 mg/kg
every 48 hours 
15 mg/kg
every 48 hours 
5–9/0.08–0.15  4 mg/kg
every 3 to 5 days 
15 mg/kg
every 3 to 5 days 
< 5/0.08  3 mg/kg
every 3 to 5 days 
4 mg/kg
every 3 to 5 days 



Usual pediatric dose
Antibacterial
Safety and efficacy have not been established {09}; however, cefonicid has been used in children 1 year of age and older, and no pediatrics-specific problems have been reported. {91} {92}


Usual geriatric dose
See Usual adult and adolescent dose .

Usual geriatric prescribing limits
25 mg (base) every twenty-four hours for patients older than seventy-five years of age, even if serum creatinine concentrations are normal {145}.

Strength(s) usually available
U.S.—


500 mg (base) (Rx) [Monocid (sodium 3.7 mEq per gram)]{09}


1 gram (base) (Rx) [Monocid (sodium 3.7 mEq per gram)]{09}


10 grams (base) (Rx) [Monocid (sodium 3.7 mEq per gram)]{09}

Canada—
Not commercially available.

Packaging and storage:
Prior to reconstitution, store in the refrigerator (2 to 8 °C [36 to 46 °F]). Protect from light.

Preparation of dosage form:
To prepare initial dilution for intramuscular or intravenous use, 2 mL of sterile water for injection should be added to each 500-mg vial, or 2.5 mL of diluent should be added to each 1-gram vial. For direct intravenous use, the resulting solution may be administered over a 3- to 5-minute period. For intravenous infusions, the resulting solution may be further diluted in 50 to 100 mL of suitable fluids (see manufacturer's package insert). {09}

For reconstitution of piggyback infusion bottles or pharmacy bulk vials, see manufacturer's labeling for instructions.

Stability:
After reconstitution for intramuscular or intravenous use, solutions retain their potency for 24 hours at room temperature or for 72 hours if refrigerated at 5 °C (41 °F). {09}

Slight yellowing of cefonicid solutions does not affect their potency. {09}

Incompatibilities:
The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle. {09}

Additional information:
A solution containing 1 gram in 18 mL of sterile water for injection is isotonic. {09}


CEFOPERAZONE

Summary of Differences
Category: Third-generation cephalosporin.

Pharmacology/pharmacokinetics:

• Achieves high biliary concentrations.Contains N-methylthiotetrazole (NMTT) side chain.


Precautions:

• Drug interactions and/or related problems—


Interacts with alcohol (disulfiram-like reaction), oral anticoagulants, and other medications that affect blood clotting.


Does not interact with probenecid.


• Medical considerations/contraindications—


Caution required in patients with history of bleeding problems, and in patients with both severe hepatic function impairment and renal dysfunction.


• Patient monitoring—


PT determinations may be required.


• Side/adverse effects—


May cause unusual bleeding or bruising.



Additional Dosing Information
Cefoperazone should be administered intramuscularly, by intermittent intravenous infusion over a 15- to 30-minute period, or by continuous intravenous infusion. Rapid bolus injection is not recommended.

Patients with impaired renal function generally do not require a reduction in dose since cefoperazone is excreted primarily in the bile. Also, patients with impaired hepatic function or biliary obstruction who are not receiving maximum doses generally do not require a reduction in dose since a corresponding increase in renal excretion (up to 90% or more) usually compensates, to a large degree, for reduced biliary excretion.

Patients with combined renal and hepatic function impairment require a reduction in dose since cefoperazone is not significantly metabolized and toxic serum concentrations may occur.


Parenteral Dosage Forms

Note: The dosing and strengths of the dosage forms available are expressed in terms of cefoperazone base (not the sodium salt).

CEFOPERAZONE INJECTION USP

Usual adult dose
Mild to moderate infections 1
Intravenous infusion, 1 to 2 grams (base) every twelve hours {10}.

Severe infections1
Intravenous infusion, 2 to 4 grams (base) every eight hours; or 3 to 6 grams every twelve hours {10}.


Note: Adults with impaired hepatic function and/or biliary obstruction should not receive more than 4 grams (base) per day {10}.
Adults with combined hepatic and renal function impairment should not receive more than 1 to 2 grams (base) per day {10}.
In patients who are receiving hemodialysis treatments, a dose should be administered following hemodialysis {10}.


Usual adult prescribing limits
12 grams (base) per day {10}. However, up to 16 grams per day have been given by continuous infusion in severely immunocompromised patients without adverse effect {10}.

Usual pediatric dose
Safety and efficacy have not been established {10}.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


1 gram in 50 mL (base) (Rx) [Cefobid (sodium 1.5 mEq per gram)]{10}


2 grams in 50 mL (base) (Rx) [Cefobid (sodium 1.5 mEq per gram)]{10}

Canada—
Not commercially available.

Packaging and storage:
Store between –25 and –10 °C (–13 and 14 °F), unless otherwise specified by manufacturer.

Preparation of dosage form:
The container should be thawed at room temperature (25 °C [77 °F]) or under refrigeration (5 °C [41 °F]) before administration, making sure that all ice crystals have melted. Thawing should not be forced by immersion in water baths or by microwave irradiation. {10}

Do not use minibags in series connections. This may result in air embolism because of residual air being drawn from the primary container before administration of intravenous solution from the secondary container is complete. {10}

Stability:
After thawing, solutions retain their potency for 48 hours at room temperature or for 14 days if refrigerated at 5 °C (41 °F). Once thawed, solutions should not be refrozen. {10}

Do not use if the solution is cloudy or contains a precipitate. {10}

Incompatibilities:
The admixture of cefoperazone with other medications, including pentamidine isethionate {82}, is not recommended.

The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle. {10}


CEFOPERAZONE FOR INJECTION USP

Usual adult dose
Mild to moderate infections 1
Intramuscular or intravenous, 1 to 2 grams (base) every twelve hours {10}.

Severe infections1
Intramuscular or intravenous, 2 to 4 grams (base) every eight hours; or 3 to 6 grams every twelve hours {10}.


Note: Adults with impaired hepatic function and/or biliary obstruction should not receive more than 4 grams (base) per day {10}.
Adults with combined hepatic and renal function impairment should not receive more than 1 to 2 grams (base) per day {10}.
In patients who are receiving hemodialysis treatments, a dose should be administered following hemodialysis {10}.


Usual adult prescribing limits
See Cefoperazone Injection USP .

Usual pediatric dose
See Cefoperazone Injection USP .

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


1 gram (base) (Rx) [Cefobid (sodium 1.5 mEq per gram)]{10}


2 grams (base) (Rx) [Cefobid (sodium 1.5 mEq per gram)]{10}


10 grams (base) (Rx) [Cefobid (sodium 1.5 mEq per gram)]{10}

Canada—
Not commercially available.

Packaging and storage:
Prior to reconstitution, store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from light.

Preparation of dosage form:
To prepare initial dilution for intramuscular use resulting in final concentrations of less than 250 mg per mL, any suitable diluent (see manufacturer's package insert) may be used. {10}

To prepare initial dilution for intramuscular use resulting in final concentrations of 250 mg per mL, 2.8 mL of sterile water for injection should be added to each 1-gram vial and shaken well until dissolution is complete. Then 1 mL of 2% lidocaine hydrochloride injection (without epinephrine) should be added and mixed well. Add 5.4 mL of sterile water for injection and 1.8 mL of 2% lidocaine hydrochloride injection to each 2-gram vial in the above manner. When a diluent other than lidocaine hydrochloride injection is used, follow the manufacturer's labeling instructions. {10}

To prepare initial dilution for intramuscular use resulting in final concentrations of 333 mg per mL, 2 mL of sterile water for injection should be added to each 1-gram vial and shaken well until dissolution is complete. Then 0.6 mL of 2% lidocaine hydrochloride injection (without epinephrine) should be added and mixed well. Add 3.8 mL of sterile water for injection and 1.2 mL of 2% lidocaine hydrochloride injection to each 2-gram vial in the above manner. When a diluent other than lidocaine hydrochloride injection is used, follow the manufacturer's labeling instructions. {10}

To prepare initial dilution for intravenous use, a minimum of 2.8 mL (5 mL preferred) of a suitable diluent (see manufacturer's package insert) should be added for each gram of cefoperazone. For intermittent infusion, the resulting solution should be further diluted in a suitable diluent (see manufacturer's package insert) and administered over a 15- to 30-minute period. For continuous infusion, the resulting solution should be further diluted to a final concentration of 2 to 25 mg per mL. {10}

The solution should be allowed to stand following reconstitution. This allows the foam to dissipate, thus permitting visual inspection for complete dissolution. Vigorous and prolonged shaking may be required for complete dissolution, especially at higher concentrations (> 333 mg per mL). The maximum solubility of cefoperazone is approximately 475 mg per mL of compatible diluent. {10}

For reconstitution of piggyback infusion bottles, see manufacturer's labeling for instructions.

Stability:
After reconstitution, solutions stored in bacteriostatic water for injection containing benzyl alcohol or parabens, most dextrose-containing injections, dextrose and sodium chloride injection, lactated Ringer's injection, 0.5% lidocaine hydrochloride injection, 0.9% sodium chloride injection, or other electrolyte-containing injections (see manufacturer's package insert) at concentrations of 2 to 300 mg per mL retain their potency for 24 hours at room temperature (15 to 25 °C [59 to 77 °F]) or for 5 days if refrigerated at 2 to 8 °C (36 to 46 °F). {10}

Solutions stored in 5% dextrose injection, or 5% dextrose and 0.2 or 0.9% sodium chloride injection at concentrations of 2 or 50 mg per mL, respectively, retain their potency for 3 weeks if frozen at -20 to -10 °C (-4 to 14 °F). {10}

Solutions stored in 0.9% sodium chloride injection or sterile water for injection at concentrations of 300 mg per mL retain their potency for 5 weeks if frozen at -20 to -10 °C (-4 to 14 °F). {10}

Frozen solutions should be thawed at room temperature prior to use. Once thawed, solutions should not be refrozen.

Solutions may vary in color from colorless to straw yellow, depending on concentration. {10}

Incompatibilities:
The admixture of cefoperazone with other medications, including pentamidine isethionate {82}, is not recommended.

The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle.


CEFOTAXIME

Summary of Differences
Category: Third-generation cephalosporin.


Additional Dosing Information
Intramuscular doses of 2 grams should be administered as divided doses in different sites.


Parenteral Dosage Forms

Note: The dosing and strengths of the dosage forms available are expressed in terms of cefotaxime free acid.

CEFOTAXIME INJECTION USP

Usual adult and adolescent dose
Perioperative prophylaxis
Cesarean section patients: Intravenous infusion, 1 gram (free acid) as soon as the umbilical cord is clamped; then 1 gram every six hours for a maximum of two doses {11}.

Other surgery patients: Intravenous infusion, 1 gram (free acid) one-half to one and one-half hours prior to the start of surgery {11}.

Septicemia
Intravenous infusion, 2 grams (free acid) every six to eight hours {11}.

For all other infections
Uncomplicated: Intravenous infusion, 1 gram (free acid) every twelve hours {11}.

Moderate to severe: Intravenous infusion, 1 to 2 grams (free acid) every eight hours {11}.

Life-threatening: Intravenous infusion, 2 grams (free acid) every four hours {11}.


Note: For patients with renal function impairment (< 20 mL per minute), one half the Usual adult and adolescent dose should be used at the same dosing intervals given above.


Usual adult prescribing limits
12 grams (free acid) per day {11}.

Usual pediatric dose
Antibacterial
Neonates up to 1 week of age: Intravenous infusion, 50 mg (free acid) per kg of body weight every twelve hours {11}.

Neonates 1 to 4 weeks of age: Intravenous infusion, 50 mg (free acid) per kg of body weight every eight hours {11}.

Infants and children 1 month of age and older up to 50 kg of body weight: Intravenous infusion, 8.3 to 30 mg (free acid) per kg of body weight every four hours; or 12.5 to 45 mg per kg of body weight every six hours {11}.

Children 50 kg of body weight and over: See Usual adult and adolescent dose {11}.


Usual pediatric prescribing limits
Infants and children up to 50 kg of body weight should not exceed 180 mg (free acid) per kg of body weight per day {121}.
Children 50 kg of body weight and over should not exceed 12 grams (free acid) per day {11}.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


1 gram (free acid) in 50 mL (Rx) [Claforan (sodium 2.2 mEq per gram)]{11}


2 grams (free acid) in 50 mL (Rx) [Claforan (sodium 2.2 mEq per gram)]{11}

Canada—
Not commercially available.

Packaging and storage:
Store between –25 and –10 °C (–13 and 14 °F), unless otherwise specified by manufacturer.

Preparation of dosage form:
The container should be thawed at room temperature or under refrigeration (at or below 5 °C [41 °F]) before administration, making sure that all ice crystals have melted. Thawing should not be forced by immersion in water baths or by microwave irradiation. {11}

Do not use minibags in series connections. This may result in air embolism because of residual air being drawn from the primary container before administration of intravenous solution from the secondary container is complete. {11}

Stability:
After thawing, solutions retain their potency for 24 hours at room temperature (22 °C [72 °F]) or for 10 days if refrigerated at 5 °C (41 °F). Once thawed, solutions should not be refrozen. {11}

Do not use if the solution is cloudy or contains a precipitate. {11}

Incompatibilities:
The admixture of cefotaxime with other medications, including pentamidine isethionate, {82} is not recommended. {11}

The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle. {11}


CEFOTAXIME FOR INJECTION USP

Usual adult and adolescent dose
Gonorrhea, cervical or urethral or
Gonorrhea, rectal, in females
Intramuscular, 500 mg (free acid) as a single dose {11}.

Gonorrhea, rectal, in males
Intramuscular, 1 gram (free acid) as a single dose {11}.

Perioperative prophylaxis
Cesarean section patients: Intravenous, 1 gram (free acid) as soon as the umbilical cord is clamped; then 1 gram, intramuscularly or intravenously, every six hours for a maximum of two doses {11} {66}.

Other surgery patients: Intramuscular or intravenous, 1 gram (free acid) one-half to one and one-half hours prior to the start of surgery {11} {66}.

Septicemia
Intravenous, 2 grams (free acid) every six to eight hours {11} {66}.

For all other infections
Uncomplicated: Intramuscular or intravenous, 1 gram (free acid) every twelve hours {11} {66}.

Moderate to severe: Intramuscular or intravenous, 1 to 2 grams (free acid) every eight hours {11} {66}.

Life-threatening: Intravenous, 2 grams (free acid) every four hours {11} {66}.


Note: For patients with renal function impairment (< 20 mL per minute), one half the Usual adult and adolescent dose should be used at the same dosing interval given above {11}.


Usual adult prescribing limits
See Cefotaxime Injection USP .

Usual pediatric dose
For bacterial infections
Neonates up to 1 week of age: Intravenous, 50 mg (free acid) per kg of body weight every twelve hours {11} {66}.

Neonates 1 to 4 weeks of age: Intravenous, 50 mg (free acid) per kg of body weight every eight hours {11} {66}.

Infants and children 1 month of age and older up to 50 kg of body weight: Intramuscular or intravenous, 8.3 to 30 mg (free acid) per kg of body weight every four hours; or 12.5 to 45 mg per kg of body weight every six hours {11} {66}.

Children 50 kg of body weight and over: See Usual adult and adolescent dose {11}.


Usual pediatric prescribing limits
See Cefotaxime Injection USP .

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


500 mg (free acid) (Rx) [Claforan (sodium 2.2 mEq per gram)]{11}


1 gram (free acid) (available in ADD-Vantage® vials) (Rx) [Claforan (sodium 2.2 mEq per gram)]{11}


2 grams (free acid) (available in ADD-Vantage® vials) (Rx) [Claforan (sodium 2.2 mEq per gram)]{11}


10 grams (free acid) (Rx) [Claforan (sodium 2.2 mEq per gram)]{11}

Canada—


500 mg (free acid) (Rx) [Claforan]{66}


1 gram (free acid) (also available in ADD-Vantage® vials) (Rx) [Claforan]{66}


2 grams (free acid) (Rx) [Claforan]{66}

Packaging and storage:
Prior to reconstitution, store below 30 °C (86 °F), preferably between 15 and 30 °C (59 and 86 °F). Protect from excessive light.

Preparation of dosage form:
To prepare initial dilution for intramuscular use, 2, 3, or 5 mL of sterile water for injection or bacteriostatic water for injection should be added to each 500-mg, 1-gram, or 2-gram vial, respectively. {11}

To prepare initial dilution for intravenous use, 10 mL of sterile water for injection should be added to each 500-mg, 1-gram, or 2-gram vial. For direct intravenous use, the resulting solution should be administered over a 3- to 5-minute period. {11}

For reconstitution of piggyback infusion bottles or pharmacy bulk vials, see manufacturer's labeling for instructions.

Caution—Use of diluents containing benzyl alcohol is not recommended for preparation of medications for use in neonates. A fatal toxic syndrome consisting of metabolic acidosis, central nervous system (CNS) depression, respiratory problems, renal failure, hypotension, and possibly seizures and intracranial hemorrhages has been associated with this use.

Stability:
After reconstitution for intramuscular use, solutions retain at least 90% of their potency for 12 hours at room temperature (22 °C [72 °F]), for at least 5 days in plastic syringes or 7 days in the original container if refrigerated (5 °C [41 °F]), or for 13 weeks if frozen. {11} {154}

After reconstitution for intravenous use, solutions retain at least 90% of their potency for 12 hours (2-gram vial) or for 24 hours (500-mg and 1-gram vials) at room temperature, for at least 5 days in plastic syringes or 7 days in the original container if refrigerated, or for 13 weeks in plastic syringes or the original container if frozen. Reconstituted solutions further diluted up to 1000 mL in suitable diluents (see manufacturer's package insert) retain their potency for 24 hours at room temperature or for at least 5 days if refrigerated. {11} {154}

Frozen solutions should be thawed at room temperature before use. Once thawed, solutions should not be refrozen. {11}

Reconstituted solutions exhibit maximum stability at pH 5 to 7. Therefore, sterile cefotaxime sodium should not be reconstituted with diluents having a pH above 7.5 (e.g., sodium bicarbonate injection). {11}

Solutions range in color from pale yellow to light amber, depending on the concentration and diluent used. However, solutions tend to darken during storage. This does not affect their potency when stored per manufacturer's recommendations. {11}

Incompatibilities:
The admixture of cefotaxime with other medications, including pentamidine isethionate, {82} is not recommended. {11}

The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle. {11}

Additional information:
A solution containing 1 gram in 14 mL of sterile water for injection is isotonic. {11}


CEFOTETAN

Summary of Differences
Category: Cephamycin; second-generation cephalosporin.

Indications: Good activity against anaerobic organisms.

Pharmacology/pharmacokinetics: Contains N-methylthiotetrazole (NMTT) side chain.

Precautions:

• Drug interactions and/or related problems—Interacts with alcohol (disulfiram-like reaction), oral anticoagulants, and other medications that affect blood clotting.


• Laboratory value alterations—May falsely elevate serum and urine creatinine concentrations when Jaffe's reaction method is used.


• Medical considerations/contraindications—Caution required in patients with history of bleeding problems.


• Patient monitoring—PT determinations may be required.


Side/adverse effects: May cause unusual bleeding or bruising.


Parenteral Dosage Forms

Note: The dosing and strengths of the dosage forms available are expressed in terms of cefotetan base (not the disodium salt).

CEFOTETAN INJECTION

Note: Cefotetan injection should be administered over a period of 20 to 60 minutes.


Usual adult and adolescent dose
Perioperative prophylaxis
Cesarean section patients: Intravenous infusion, 1 or 2 grams (base) as soon as the umbilical cord is clamped {12}.

Other surgical patients: Intravenous infusion, 1 or 2 grams (base) one-half to one hour prior to the start of surgery {12}.

Skin and soft tissue infections
Mild to moderate, due to Klebsiella pneumoniae : Intravenous infusion, 1 or 2 grams (base) every twelve hours for five to ten days {12}.

Mild to moderate, due to other organisms: Intravenous infusion, 1 gram (base) every twelve hours for five to ten days; or 2 grams every twenty-four hours for five to ten days {12}.

Severe: Intravenous infusion, 2 grams (base) every twelve hours for five to ten days {12}.

Urinary tract infections
Intravenous infusion, 500 mg (base) every twelve hours for five to ten days; or 1 or 2 grams every twelve or twenty-four hours for five to ten days {12}.

For all other infections
Mild to moderate: Intravenous infusion, 1 or 2 grams (base) every twelve hours for five to ten days {12}.

Severe: Intravenous infusion, 2 grams (base) every twelve hours for five to ten days {12}.

Life-threatening: Intravenous infusion, 3 grams (base) every twelve hours for five to ten days {12}.


Note: Adults with renal function impairment may require a reduction in dose as follows {12}:

Creatinine clearance
(mL/min)/(mL/sec) 
Dose (base) determined by type and severity of infection 
> 30/0.5  See Usual adult and adolescent dose
10–30/0.17–0.5  Usual adult dose every 24 hours; or one half the usual adult dose every 12 hours
< 10/0.17  Usual adult dose every 48 hours; or one fourth the usual adult dose every 12 hours
Hemodialysis patients  One fourth the usual adult dose every 24 hours on the days between hemodialysis sessions; and one half the usual adult dose on the day of hemodialysis



Usual adult prescribing limits
6 grams (base) per day {12}.

Usual pediatric dose
Safety and efficacy have not been established {12}.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


1 gram (base) in 50 mL [Cefotan (sodium 3.5 mEq per gram)]{12}


2 grams (base) in 50 mL [Cefotan (sodium 3.5 mEq per gram)]{12}

Canada—
Not commercially available.

Packaging and storage:
Store at –20 °C (–4 °F). {12}

Preparation of dosage form:
The container should be thawed at room temperature (25 °C [77 °F]) or under refrigeration (5 °C [41 °F]) before administration. Thawing should not be forced by immersion in water baths or microwave irradiation. {12}

Do not use minibags in series connections. This may result in air embolism because of residual air being drawn from the primary container before administration of intravenous solution from the secondary container is complete. {12}

Stability:
After thawing, solutions retain their potency for 48 hours at room temperature, or for 21 days if refrigerated. Once thawed, solutions should not be refrozen. {12}

Do not use if the solution is cloudy or contains a precipitate. {12}

Incompatibilities:
The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle. {12}


CEFOTETAN FOR INJECTION USP

Usual adult and adolescent dose
Perioperative prophylaxis
Cesarean section patients: Intravenous, 1 or 2 grams (base) as soon as the umbilical cord is clamped {12} {67}.

Other surgical patients: Intravenous, 1 or 2 grams (base) one-half to one hour prior to the start of surgery {12} {67}.

Skin and soft tissue infections
Mild to moderate, due to Klebsiella pneumoniae : Intramuscular or intravenous, 1 or 2 grams (base) every twelve hours for five to ten days {12}.

Mild to moderate, due to other organisms: Intramuscular or intravenous, 1 gram (base) every twelve hours for five to ten days; or 2 grams, intravenously, every twenty-four hours for five to ten days {12}.

Severe: Intravenous, 2 grams (base) every twelve hours for five to ten days {12} {67}.

Urinary tract infections
Intramuscular or intravenous, 500 mg (base) every twelve hours, or 1 or 2 grams every twelve or twenty-four hours, for five to ten days {12} {67}.

For all other infections
Mild to moderate: Intramuscular or intravenous, 1 or 2 grams (base) every twelve hours for five to ten days {12} {67}.

Severe: Intravenous, 2 grams (base) every twelve hours for five to ten days {12} {67}.

Life-threatening: Intravenous, 3 grams (base) every twelve hours for five to ten days {12} {67}.


Note: Adults with renal function impairment may require a reduction in dose. See Cefotetan Injection .


Usual adult prescribing limits
See Cefotetan Injection .

Usual pediatric dose
Safety and efficacy have not been established {12}.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


1 gram (base) (available in ADD-Vantage® vials) (Rx) [Cefotan ( sodium 3.5 mEq per gram)]{12}


2 grams (base) (available in ADD-Vantage® vials) (Rx) [Cefotan ( sodium 3.5 mEq per gram)]{12}


10 grams (base) (Rx) [Cefotan (sodium 3.5 mEq per gram)]{12}

Canada—


1 gram (base) (Rx) [Cefotan (sodium 3.4 mEq per gram)]{67}


2 grams (base) (Rx) [Cefotan (sodium 3.4 mEq per gram)]{67}

Packaging and storage:
Prior to reconstitution, do not store above 22 °C (72 °F), unless otherwise specified by manufacturer. Protect from light.

Preparation of dosage form:
To prepare initial dilution for intramuscular use, 2 mL of sterile water for injection, bacteriostatic water for injection, 0.9% sodium chloride injection, or 0.5 or 1% lidocaine hydrochloride injection (without epinephrine) should be added to each 1-gram vial, or 3 mL of diluent should be added to each 2-gram vial. {12}

To prepare initial dilution for intravenous use, 10 mL of sterile water for injection should be added to each 1-gram vial, or 10 to 20 mL of diluent should be added to each 2-gram vial. For direct intermittent intravenous use, the resulting solution should be administered over a 3- to 5-minute period. {12}

For reconstitution of piggyback infusion bottles, add 50 to 100 mL of 5% dextrose injection or 0.9% sodium chloride injection to each bottle. If the Y-type method of administration is used, the primary infusion should be temporarily discontinued during infusion of cefotetan. {12}

For reconstitution of ADD-Vantage® vials, see manufacturer's package labeling for instructions.

Stability:
After reconstitution for intramuscular or intravenous use, solutions retain their potency for 24 hours at room temperature (25 °C [77 °F]), for 96 hours if refrigerated at 5 °C (41 °F), or for at least 1 week if frozen at –20 °C (–4 °F). Solutions stored in disposable glass or plastic syringes retain their potency for 24 hours at room temperature or for 96 hours if refrigerated. {12}

Frozen solutions should be thawed at room temperature prior to use. Thawed solutions retain their potency for the time periods indicated above. Once thawed, solutions should not be refrozen. {12}

After reconstitution of ADD-Vantage® vials, solutions retain their potency for 24 hours at room temperature. Solutions in ADD-Vantage® vials should not be refrigerated or frozen. {12}

Solutions range from colorless to yellow in color, depending on the concentration. {12}

Incompatibilities:
The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle. {12}


CEFOXITIN

Summary of Differences
Category: Cephamycin; second-generation cephalosporin.

Indications: Good activity against anaerobic organisms.

Precautions:

• Pediatrics—Higher doses associated with increased incidence of eosinophilia and elevated AST (SGOT).


• Laboratory value alterations—May falsely elevate serum and urine creatinine concentrations when Jaffe's reaction method is used.



Parenteral Dosage Forms

Note: The dose and strengths of the dosage forms available are expressed in terms of cefoxitin base (not the sodium salt).

CEFOXITIN INJECTION USP

Usual adult and adolescent dose
Mild or uncomplicated infections
Intravenous, 1 gram (base) every six to eight hours {13}.

Moderately severe or severe infections
Intravenous, 1 gram (base) every four hours; or 2 grams every six to eight hours {13}.

Life-threatening infections
Intravenous, 2 grams (base) every four hours; or 3 grams every six hours {13}.

Perioperative prophylaxis
Cesarean section patients: Intravenous, 2 grams (base) as soon as the umbilical cord is clamped; or 2 grams as soon as the umbilical cord is clamped, and 2 grams four and eight hours after the first dose {13}.

Other surgical patients: Intravenous, 2 grams (base) one-half to one hour prior to the start of surgery, and 2 grams every six hours after the first dose for up to twenty-four hours {13}.


Note: After an initial loading dose of 1 to 2 grams (base), adults with impaired renal function may require a reduction in dose as follows {13}:

Creatinine clearance
(mL/min)/(mL/sec) 
Dose (base) 
> 50/0.83  See Usual adult and adolescent dose
30–50/0.5–0.83   1–2 grams every 8–12 hours 
10–29/0.17–0.48  1–2 grams every 12–24 hours 
5–9/0.08–0.15  500 mg–1 gram every 12–24 hours 
< 5/0.08  500 mg–1 gram every 24–48 hours 



Usual pediatric dose
Perioperative prophylaxis
Intravenous infusion, 30 to 40 mg (base) per kg of body weight one-half to one hour prior to the start of surgery; and 30 to 40 mg per kg of body weight every six hours after the first dose for up to twenty-four hours {13}.

For all other infections
Infants and children 3 months of age and older: Intravenous infusion, 13.3 to 26.7 mg (base) per kg of body weight every four hours; or 20 to 40 mg per kg of body weight every six hours {13}.

Infants 1 to 3 months of age: Intravenous infusion, 20 to 40 mg (base) per kg of body weight every six to eight hours {140}.

Infants 1 to 4 weeks of age: Intravenous infusion, 20 to 40 mg (base) per kg of body weight every eight hours {140}.

Premature infants weighing 1500 grams or over to neonates up to 1 week of age: Intravenous infusion, 20 to 40 mg (base) per kg of body weight every twelve hours {140}.


Note: Pediatric patients with renal function impairment should receive a modified dose and a modified frequency of dosing consistent with the recommendations for adults {13}. See Usual adult and adolescent dose .


Usual pediatric prescribing limits
12 grams (base) per day {13}.

Usual geriatric dose
See Usual adult and adolescent dose .

Usual geriatric prescribing limits
2 grams (base) every eight hours for patients older than seventy-five years of age, even if serum creatinine concentrations are normal {145}.

Strength(s) usually available
U.S.—


1 gram in 50 mL (Rx) [Mefoxin (sodium 2.3 mEq per gram)]{13}


2 grams in 50 mL (Rx) [Mefoxin (sodium 2.3 mEq per gram)]{13}

Canada—
Not commercially available.

Packaging and storage:
Store between –25 and –10 °C (–13 and 14 °F), unless otherwise specified by manufacturer.

Preparation of dosage form:
The container should be thawed at room temperature (25 °C [77 °F]) or under refrigeration (2 to 8 °C [36 to 46 °F]) before administration, making sure that all ice crystals have melted. Thawing should not be forced by immersion in water baths or by microwave irradiation. {13}

Do not use minibags in series connections. This may result in air embolism because of residual air being drawn from the primary container before administration of intravenous solution from the secondary container is complete.

Stability:
After thawing, solutions retain their potency for 24 hours at room temperature or for 21 days if refrigerated at 2 to 8 °C (36 to 46 °F). Once thawed, solutions should not be refrozen. {13}

Do not use if the solution is cloudy or contains a precipitate. {13}

Incompatibilities:
The admixture of cefoxitin with other medications, including pentamidine isethionate {82}, is not recommended.

The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle.


CEFOXITIN FOR INJECTION USP

Usual adult and adolescent dose
See Cefoxitin Injection USP .

Usual pediatric dose
See Cefoxitin Injection USP .

Usual pediatric prescribing limits
See Cefoxitin Injection USP .

Usual geriatric dose
See Cefoxitin Injection USP .

Usual geriatric prescribing limits
See Cefoxitin Injection USP .

Strength(s) usually available
U.S.—


1 gram (available in ADD-Vantage® vials) (Rx) [Mefoxin ( sodium 2.3 mEq per gram)]{13}


2 grams (available in ADD-Vantage® vials) (Rx) [Mefoxin ( sodium 2.3 mEq per gram)]{13}


10 grams (Rx) [Mefoxin (sodium 2.3 mEq per gram)]{13}

Canada—


1 gram (also may be available in ADD-Vantage® vials) (Rx) [Mefoxin (sodium 2.3 mEq per gram)]{68}[Generic]


2 grams (also may be available in ADD-Vantage® vials) (Rx) [Mefoxin (sodium 2.3 mEq per gram)]{68}[Generic]


10 grams (Rx) [Mefoxin (sodium 2.3 mEq per gram)]{68}

Packaging and storage:
Prior to reconstitution, store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Preparation of dosage form:
To prepare initial dilution for intravenous use, at least 10 mL of sterile water for injection, bacteriostatic water for injection, 0.9% sodium chloride injection, or 5% dextrose injection should be added to each 1-gram vial, or 10 or 20 mL of diluent should be added to each 2-gram vial. For continuous intravenous infusion, the resulting solution may be further diluted in 50 to 1000 mL of suitable diluent (see manufacturer's package insert). {13}

To prepare initial dilution for direct intermittent intravenous use, 10 mL of sterile water for injection should be added to each 1- or 2-gram vial. The resulting solution should be administered over a 3- to 5-minute period. {13}

For reconstitution of piggyback infusion bottles or pharmacy bulk vials, see manufacturer's labeling for instructions.

Caution—Use of diluents containing benzyl alcohol is not recommended for preparation of medications for use in neonates. A fatal toxic syndrome consisting of metabolic acidosis, CNS depression, respiratory problems, renal failure, hypotension, and possibly seizures and intracranial hemorrhages has been associated with this use. {13} {68}

Stability:
After reconstitution for intravenous use to a concentration of 1 gram per 10 mL with sterile water for injection, bacteriostatic water for injection, 0.9% sodium chloride injection, or 5% dextrose injection, solutions retain their potency for 6 hours at room temperature, or for 7 days if refrigerated (below 5 °C). Initial dilutions retain their potency for an additional 18 hours at room temperature or for an additional 48 hours if refrigerated when diluted in 50 to 1000 mL of suitable diluents (see manufacturer's package insert). {13}

Solutions range from clear to light amber in color but tend to darken depending on storage conditions. This does not affect their potency. {13}

Incompatibilities:
The admixture of cefoxitin with other medications, including pentamidine isethionate {82}, is not recommended.

The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle. {13}


CEFPODOXIME

Summary of Differences
Category: Third-generation cephalosporin, with broad in vitro activity. One of three oral third-generation cephalosporins.

Precautions:

• Drug interactions and/or related problems—Interacts with antacids and histamine H 2-receptor antagonists.



Additional Dosing Information
The tablet dosage form should be taken with food.

The oral suspension dosage form may be taken with or without food.


Oral Dosage Forms

Note: The dosing and strengths of the dosage forms available are expressed in terms of cefpodoxime base (not the proxetil salt).

CEFPODOXIME PROXETIL FOR ORAL SUSPENSION

Usual adult and adolescent dose
Gonorrhea, cervical1 or urethral1 or
Gonorrhea, rectal, in women1
Oral, 200 mg (base) as a single dose {14}.

Pharyngitis1or
Tonsillitis1
Oral, 100 mg (base) every twelve hours for five to ten days {14}.

Pneumonia, community-acquired 1
Oral, 200 mg (base) every twelve hours for fourteen days {14}.

Skin and soft tissue infections 1
Oral, 400 mg (base) every twelve hours for seven to fourteen days {14}.

Urinary tract infections, uncomplicated1
Oral, 100 mg (base) every twelve hours for seven days {14}.


Note: Adults with renal function impairment may require a reduction in dose as follows {14}:

Creatinine clearance
(mL/min)/(mL/sec) 
Dosing interval 
³ 30/0.5  Every 12 hours 
<30/0.5  Every 24 hours 
Hemodialysis patients  3 times a week after hemodialysis 



Usual pediatric dose
Otitis media1
Infants and children 5 months to 12 years of age: Oral, 10 mg (base) per kg of body weight, up to 400 mg, every twenty-four hours for ten days; or 5 mg per kg of body weight, up to 200 mg, every twelve hours for ten days {14}.

Infants up to 5 months of age: Safety and efficacy have not been established {14}.

Pharyngitis1or
Tonsillitis1
Infants and children 5 months to 12 years of age: Oral, 5 mg (base) per kg of body weight, up to 100 mg, every twelve hours for five to ten days {14}.

Infants up to 5 months of age: Safety and efficacy have not been established {14}.


Usual pediatric prescribing limits
For otitis media, 400 mg per day. For pharyngitis or tonsillitis, 200 mg per day. {14}

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


50 mg (base) per 5 mL (when reconstituted according to manufacturer's instructions) (available in 50-, 75-, and 100-mL bottles) (Rx) [Vantin ( lactose) (sodium benzoate) ( sucrose)]{14}


100 mg (base) per 5 mL (when reconstituted according to manufacturer's instructions) (available in 50-, 75-, and 100-mL bottles) (Rx) [Vantin ( lactose) (sodium benzoate) ( sucrose)]{14}

Canada—
Not commercially available.

Packaging and storage:
Prior to reconstitution, store between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. {14}

Preparation of dosage form:
The bottle should be tapped to loosen the granules. The total volume of water should be added in two portions, shaking well after each addition {14}.


Final concentration  Bottle size  Total volume of water to be added  
50 mg/5 mL  100 mL   58 mL 
  75 mL  44 mL 
  50 mL  29 mL 
100 mg/5 mL  100 mL  57 mL 
  75 mL  43 mL 
  50 mL  29 mL 

Stability:
After reconstitution, suspension retains its potency for 14 days if refrigerated at 2 to 8 °C (36 to 46 °F). {14}

Auxiliary labeling:
   • Refrigerate.
   • Shake well.
   • May be taken with or without food.
   • Continue medicine for full time of treatment.
   • Beyond-use date.

Note: When dispensing, include a calibrated liquid-measuring device.



CEFPODOXIME PROXETIL TABLETS

Usual adult and adolescent dose
Bronchitis, bacterial exacerbations1
Oral, 200 mg (base) every twelve hours for ten days {14}.

Gonorrhea, cervical1 or urethral1 or
Gonorrhea, rectal, in women1
Oral, 200 mg (base) as a single dose {14}.

Pharyngitis1or
Tonsillitis1
Oral, 100 mg (base) every twelve hours for five to ten days {14}.

Pneumonia, community-acquired 1
Oral, 200 mg (base) every twelve hours for fourteen days {14}.

Skin and soft tissue infections 1
Oral, 400 mg (base) every twelve hours for seven to fourteen days {14}.

Urinary tract infections, uncomplicated1
Oral, 100 mg (base) every twelve hours for seven days {14}.


Usual pediatric dose
This dosage form usually is not used for children. See Cefpodoxime Proxetil for Oral Suspension .

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


100 mg (base) (Rx) [Vantin (lactose)]{14}


200 mg (base) (Rx) [Vantin (lactose)]{14}

Canada—
Not commercially available.

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Continue medicine for full time of treatment.
   • Take with food.


CEFPROZIL

Summary of Differences
Category: Second-generation cephalosporin, with broad in vitro activity.

Precautions:

• Medical considerations/contraindications—Cefprozil for oral solution contains 28 mg of phenylalanine per 5 mL.



Oral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

CEFPROZIL FOR ORAL SUSPENSION USP

Usual adult and adolescent dose
Bronchitis1 or
Bronchitis, bacterial exacerbations1
Oral, 500 mg every twelve hours for ten days {15}.

Pharyngitis or
Tonsillitis
Oral, 500 mg every twenty-four hours for ten days {15} {69}.

Sinusitis, acute
Oral, 250 or 500 mg every twelve hours for ten days {15} {69}.

Skin and soft tissue infections
Oral, 250 or 500 mg every twelve hours for ten days; or 500 mg every twenty-four hours for ten days {15} {69}.

[Urinary tract infections, uncomplicated]
Oral, 500 mg every twenty-four hours {69}.


Note: Adults with renal function impairment may require a reduction in dose as follows {15} {69}:

Creatinine clearance
(mL/min)/(mL/sec) 
Usual dose (%) 
³ 30/0.5  100 
0–30/0–0.5   50 
Hemodialysis patients   100, after hemodialysis  



Usual pediatric dose
Otitis media
Infants and children 6 months to 12 years of age: Oral, 15 mg per kg of body weight every twelve hours for ten days {15} {69}.

Infants up to 6 months of age: Safety and efficacy have not been established {15} {69}.

Pharyngitis or
Tonsillitis
Children 2 to 12 years of age: Oral, 7.5 mg per kg of body weight every twelve hours for ten days {15} {69}.

Infants and children up to 2 years of age: Safety and efficacy have not been established {15} {69}.

Sinusitis, acute
Infants and children 6 months to 12 years of age: Oral, 7.5 or 15 mg per kg of body weight every twelve hours for ten days {15} {69}.

Infants up to 6 months of age: Safety and efficacy have not been established {15} {69}.

Skin and soft tissue infections
Children 2 to 12 years of age: Oral, 20 mg per kg of body weight every twenty-four hours for ten days {15} {69}.

Infants and children up to 2 years of age: Safety and efficacy have not been established {15} {69}.


Usual pediatric prescribing limits
1 gram per day {69}.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


125 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 50-, 75-, and 100-mL bottles) (Rx) [Cefzil ( phenylalanine 28 mg per 5 mL) (sodium benzoate) (sodium chloride) (sucrose)]{15}


250 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 50-, 75-, and 100-mL bottles) (Rx) [Cefzil ( phenylalanine 28 mg per 5 mL) (sodium benzoate) (sodium chloride) (sucrose)]{15}

Canada—


125 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 75- and 100-mL bottles) (Rx) [Cefzil (phenylalanine 28 mg per 5 mL) (sodium benzoate) (sodium chloride) (sucrose)]{69}


250 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 75- and 100-mL bottles) (Rx) [Cefzil (phenylalanine 28 mg per 5 mL) (sodium benzoate) (sodium chloride) (sucrose)]{69}

Packaging and storage:
Prior to reconstitution, store between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Preparation of dosage form:
The bottle should be tapped to loosen the granules. The total volume of water indicated below should be added in two portions, shaking well after each addition {15}.


Bottle size  Total volume of water
to be added 
50 mL  36 mL 
75 mL  54 mL 
100 mL  72 mL 

Stability:
After reconstitution, suspension retains its potency for 14 days if refrigerated.

Auxiliary labeling:
   • Refrigerate.
   • Shake well.
   • Continue medicine for full time of treatment.
   • Beyond-use date.

Note: When dispensing, include a calibrated liquid-measuring device.



CEFPROZIL TABLETS USP

Usual adult and adolescent dose
See Cefprozil for Oral Suspension USP .

Usual pediatric dose
See Cefprozil for Oral Suspension USP .

Usual pediatric prescribing limits
See Cefprozil for Oral Suspension USP .

Usual geriatric dose
See Cefprozil for Oral Suspension USP

Strength(s) usually available
U.S.—


250 mg (Rx) [Cefzil]{15}


500 mg (Rx) [Cefzil]{15}

Canada—


250 mg (Rx) [Cefzil]{69}


500 mg (Rx) [Cefzil]{69}

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Continue medicine for full time of treatment.


CEFTAZIDIME

Summary of Differences
Category: Third-generation cephalosporin.

Indications: Good activity against Pseudomonas aeruginosa .

Precautions:

• Drug interactions and/or related problems—Does not interact with probenecid.



Additional Dosing Information
Patients with impaired hepatic function do not require a reduction in dose.


Parenteral Dosage Forms

Note: The dosing and strengths of the dosage form available are expressed in terms of ceftazidime base (not the sodium salt).

CEFTAZIDIME INJECTION USP

Usual adult and adolescent dose
Bone and joint infections
Intravenous infusion, 2 grams (base) every twelve hours {17}.

Intraabdominal infections or
Meningitis or
Pelvic infections, female1 or
Septicemia
Intravenous infusion, 2 grams (base) every eight hours {17}.

Pneumonia, uncomplicated or
Skin and soft tissue infections
Intravenous infusion, 500 mg to 1 gram (base) every eight hours {17}.

[Melioidosis ]1
Intravenous, 120 mg per kg of body weight per day administered every eight hours{163}{164}{165}{166}{167}{168}{169}{170}{171}{172}

Pulmonary infections in cystic fibrosis, due to Pseudomonas1
Intravenous infusion, 30 to 50 mg (base) per kg of body weight every eight hours, up to 6 grams per day {17}.

Urinary tract infections, complicated
Intravenous infusion, 500 mg (base) every eight to twelve hours {17}.

Urinary tract infections, uncomplicated
Intravenous infusion, 250 mg (base) every twelve hours {17}.

For all other infections, severe to life-threatening, especially in immunocompromised patients
Intravenous infusion, 2 grams (base) every eight hours {17}.


Note: After an initial loading dose of 1 gram, adults with impaired renal function (including dialysis patients) may require a reduction in dose as follows {17}:

Creatinine clearance
(mL/min)/(mL/sec) 
Dose (base) 
> 50/0.83  See Usual adult and adolescent
dose

31–50/0.52–0.83   1 gram every 12 hours  
16–30/0.27–0.5   1 gram every 24 hours 
6–15/0.1–0.25  500 mg every 24 hours 
< 5/0.08  500 mg every 48 hours  
Hemodialysis patients   1 gram after each
hemodialysis period 
Peritoneal dialysis patients  500 mg every 24 hours 



Usual pediatric dose
For bacterial infections
Neonates up to 4 weeks of age: Intravenous infusion, 30 mg (base) per kg of body weight every twelve hours {17}.

Infants and children 1 month to 12 years of age: Intravenous infusion, 30 to 50 mg (base) per kg of body weight every eight hours {17}.


Usual pediatric prescribing limits
6 grams (base) per day {17}.

Usual geriatric dose
See Usual adult and adolescent dose .

Usual geriatric prescribing limits
1 gram (base) every twenty-four hours for patients older than seventy-five years of age, even if serum creatinine concentrations are normal {145}.

Strength(s) usually available
U.S.—


1 gram in 50 mL (Rx) [Fortaz (sodium 2.3 mEq per gram)]{17}


2 grams in 50 mL (Rx) [Fortaz (sodium 2.3 mEq per gram)]{17}

Canada—
Not commercially available.

Packaging and storage:
Store between –25 and –10 °C (–13 and 14 °F), unless otherwise specified by manufacturer.

Preparation of dosage form:
The container should be thawed at room temperature (25 °C [77 °F]) or under refrigeration (5 °C [41 °F]) before administration, making sure that all ice crystals have melted. Thawing should not be forced by immersion in water bath or by microwave irradiation. {17}

Do not use minibags in series connections. This may result in air embolism because of residual air being drawn from the primary container before administration of intravenous solution from the secondary container is complete. {17}

Stability:
After thawing, solutions retain their potency for 24 hours at room temperature or for 7 days if refrigerated. Once thawed, solutions should not be refrozen. {17}

Do not use if the solution is cloudy or contains a precipitate. {17}

Incompatibilities:
The admixture of ceftazidime with other medications, including aminophylline, amsacrine, fluconazole, idarubicin hydrochloride, pentamidine isethionate, sargramostim, and vancomycin, is not recommended {82} {151}.

The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle.

Vancomycin is physically incompatible with ceftazidime and a precipitate may form, depending on the concentration. Therefore, the intravenous lines should be flushed between the administration of these two medications if they are to be given through the same tubing. {17}


CEFTAZIDIME FOR INJECTION USP

Usual adult and adolescent dose
Bone and joint infections
Intravenous, 2 grams (base) every twelve hours {16} {17} {18} {19} {71}.

Intraabdominal infections or
Meningitis or
Pelvic infections, female1 or
Septicemia
Intravenous, 2 grams (base) every eight hours {16} {17} {18} {19} {71}.

[Melioidosis ]1
Intravenous, 120 mg per kg of body weight per day administered every eight hours{163}{164}{165}{166}{167}{168}{169}{170}{171}{172}

Pneumonia, uncomplicated or
Skin and soft tissue infections
Intramuscular or intravenous, 500 mg to 1 gram (base) every eight hours {16} {17} {18} {19} {71}.

Pulmonary infections in cystic fibrosis, due to Pseudomonas1
Intravenous, 30 to 50 mg (base) per kg of body weight every eight hours, up to 6 grams per day {16} {17} {18} {19}.

Urinary tract infections, complicated
Intramuscular or intravenous, 500 mg (base) every eight to twelve hours {16} {17} {18} {19} {71}.

Urinary tract infections, uncomplicated
Intramuscular or intravenous, 250 mg (base) every twelve hours {16} {17} {18} {19} {71}.

For all other infections, severe to life-threatening, especially in immunocompromised patients
Intravenous, 2 grams (base) every eight hours {16} {17} {18} {19} {57}.


Note: Adults with renal function impairment may require a reduction in dose. See Ceftazidime Injection USP .


Usual pediatric dose
Meningitis
Infants and children 1 month to 12 years of age: Intravenous, 50 mg (base) per kg of body weight every eight hours {17} {71}.

Neonates up to 1 month of age: Intravenous, 25 to 50 mg (base) per kg of body weight every twelve hours {71}.

For all other infections
Infants and children 1 month to 12 years of age: Intravenous, 30 to 50 mg (base) per kg of body weight every eight hours {17} {18} {19}.

Neonates up to 4 weeks of age: Intravenous, 30 mg (base) per kg of body weight every twelve hours {17} {18} {19}.


Note: The safety of the arginine component in the ceftazidime L-arginine formulation has not been established for neonates, infants, or children up to 12 years of age {16}. If treatment with ceftazidime is indicated, the sodium formulation should be used {122}.


Usual pediatric prescribing limits
See Ceftazidime Injection USP .

Usual geriatric dose
See Usual adult and adolescent dose .

Usual geriatric prescribing limits
See Ceftazidime Injection USP .

Strength(s) usually available
U.S.—


500 mg (Rx) [Fortaz (sodium 2.3 mEq per gram)]{17} [Tazidime (sodium 2.3 mEq per gram)]{19}


1 gram (may be available in ADD-Vantage® vials) (Rx) [Ceptaz (L-arginine 349 mg per gram)]{16} [Fortaz (sodium 2.3 mEq per gram)]{17} [Tazicef (sodium 2.3 mEq per gram)]{18} [Tazidime (sodium 2.3 mEq per gram)]{19}


2 grams (may be available in ADD-Vantage® vials) (Rx) [Ceptaz (L-arginine 349 mg per gram)]{16} [Fortaz (sodium 2.3 mEq per gram)]{17} [Tazicef (sodium 2.3 mEq per gram)]{18} [Tazidime (sodium 2.3 mEq per gram)]{19}


6 grams (Rx) [Fortaz (sodium 2.3 mEq per gram)]{17} [Tazicef (sodium 2.3 mEq per gram)]{18} [Tazidime (sodium 2.3 mEq per gram)]{19}


10 grams (Rx) [Ceptaz (L-arginine 349 mg per gram)]{16}

Canada—


500 mg (Rx) [Fortaz]{71} [Tazidime (sodium 2.3 mEq per gram)]{57}


1 gram (also may be available in ADD-Vantage® vials) (Rx) [Ceptaz (L-arginine)]{70} [Fortaz]{71} [Tazidime (sodium 2.3 mEq per gram)]{57}


2 grams (also may be available in ADD-Vantage® vials) (Rx) [Ceptaz (L-arginine)]{70} [Fortaz]{71} [Tazidime (sodium 2.3 mEq per gram)]{57}


6 grams (Rx) [Fortaz]{71} [Tazidime (sodium 2.3 mEq per gram)]{57}


10 grams (Rx) [Ceptaz (L-arginine )]{70}

Packaging and storage:
Prior to reconstitution, store between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from light.

Preparation of dosage form:
To prepare solution for intramuscular use, 1.5 mL of suitable diluent (see manufacturer's package insert) should be added to each 500-mg vial, or 3 mL of diluent should be added to each 1-gram vial. {16} {17} {18} {19}

To prepare initial dilution for intravenous use, 3 or 5 mL of suitable diluent (see manufacturer's package insert) should be added to each 500-mg vial, or 10 mL of diluent should be added to each 1- or 2-gram vial, according to manufacturer's labeling instructions. For direct intermittent intravenous use, the resulting solution should be administered slowly over a 3- to 5-minute period. For intravenous infusion, the resulting solution may be further diluted in suitable fluids according to the manufacturer's labeling instructions. {16} {17} {18} {19}

For reconstitution of piggyback infusion bottles and pharmacy bulk vials, see manufacturer's labeling for instructions. If the Y-type method of administration is used, the primary infusion should be temporarily discontinued during infusion of ceftazidime. {16} {17} {18} {19}

After reconstitution of the sodium carbonate formulation, carbon dioxide is formed, causing positive pressure inside the vial. This may require venting. {17} {18} {19}

Do not use minibags in series connections. This may result in air embolism because of residual air being drawn from the primary container before administration of intravenous solution from the secondary container is complete. {16} {17} {18} {19}

Caution—Use of diluents containing benzyl alcohol is not recommended for preparation of medications for use in neonates. A fatal toxic syndrome consisting of metabolic acidosis, CNS depression, respiratory problems, renal failure, hypotension, and possibly seizures and intracranial hemorrhages has been associated with this use.

Stability:
After reconstitution for intramuscular use with sterile water for injection, bacteriostatic water for injection, or lidocaine hydrochloride injection, solutions retain their potency for at least 18 hours at room temperature or for 7 days if refrigerated. Solutions that are frozen immediately after reconstitution in the original container retain their potency for at least 3 months at –20 °C (–4 °F). {16} {17} {18} {19}

After reconstitution for intravenous use, solutions retain their potency for at least 18 hours at room temperature or for 7 days if refrigerated. Solutions that are frozen immediately after reconstitution with sterile water for injection in the original container retain their potency for at least 3 months at –20 °C (–4 °F). {16} {17} {18} {19}

Once thawed, solutions should not be refrozen. Thawed solutions retain their potency for at least 8 hours at room temperature or for at least 4 days if refrigerated. {16} {17} {18} {19}

Intravenous infusions at concentrations from 1 to 40 mg per mL retain their potency for at least 18 hours at room temperature or for 7 days if refrigerated, when stored in suitable fluids (see manufacturer's package insert). However, storage in sodium bicarbonate injection is not recommended since ceftazidime is less stable in sodium bicarbonate than in other fluids. {16} {17} {18} {19}

Solutions range in color from light yellow to amber, depending on the diluent and volume. Ceftazidime powder and solutions tend to darken, depending on storage conditions. This does not affect their potency. {16} {17} {18} {19}

Incompatibilities:
The admixture of ceftazidime with other medications, including pentamidine isethionate {82}, is not recommended.

The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle. {16} {17} {18} {19}

Vancomycin is physically incompatible with ceftazidime and a precipitate may form, depending on the concentration. Therefore, the intravenous lines should be flushed between the administration of these two medications if they are to be given through the same tubing. {16} {17} {18} {19}


CEFTIBUTEN

Summary of Differences
Category: Third-generation. One of three oral third-generation cephalosporins.


Additional Dosing Information
The capsule and oral suspension dosage forms are bioequivalent.

The oral suspension should be taken at least 2 hours before or 1 hour after a meal.


Oral Dosage Forms

CEFTIBUTEN CAPSULES

Usual adult and adolescent dose
Bronchitis, bacterial exacerbations1 or
Otitis media1or
Pharyngitis1 or
Tonsillitis1
Oral, 400 mg once a day for ten days {20}.


Note: Adults with renal function impairment may require a reduction in dose as follows {20}:

Creatinine clearance
(mL/min)/(mL/sec) 
Dosing 
Capsules  Oral suspension  
> 50/0.83  See Usual adult and adolescent dose
9 mg/kg once
every 24 hours 
30–49/0.5–0.82  200 mg once
every 24 hours 
4.5 mg/kg once
every 24 hours 
5–29/0.1–0.49  100 mg once
every 24 hours 
2.25 mg/kg once
every 24 hours 
For patients undergoing hemodialysis two or three times a week, a single dose of 400 mg (capsules) or 9 mg/kg, up to 400 mg (oral suspension), may be administered at the end of each hemodialysis session. 



Usual adult and adolescent prescribing limits
400 mg per day {20}.

Usual pediatric dose
This dosage form usually is not used for children. See Ceftibuten for Oral Suspension .

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


400 mg (Rx) [Cedax (benzyl alcohol) ( butylparaben) (methylparaben) ( propylparaben)]{20}

Canada—
Not commercially available.

Packaging and storage:
Store between 2 and 25 °C (36 and 77 °F) in a tight container {20}.

Auxiliary labeling:
   • Continue medicine for full time of treatment.


CEFTIBUTEN FOR ORAL SUSPENSION

Usual adult and adolescent dose
See Ceftibuten Capsules .

Usual adult and adolescent prescribing limits
See Ceftibuten Capsules .

Usual pediatric dose
Otitis media1 or
Pharyngitis1 or
Tonsillitis1
Infants and children 6 months to 12 years of age: Oral, 9 mg per kg of body weight once a day for ten days {20}.

Infants up to 6 months of age: Safety and efficacy have not been established {20}.


Usual pediatric prescribing limits
400 mg per day {20}.

Usual geriatric dose
See Ceftibuten Capsules .

Strength(s) usually available
U.S.—


90 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 30-, 60-, 90-, and 120-mL bottles) (Rx) [Cedax ( sodium benzoate) (sucrose 1 gram per 5 mL)]{20}


180 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 30-, 60-, and 120-mL bottles) (Rx) [Cedax ( sodium benzoate) (sucrose 1 gram per 5 mL)]{20}

Canada—
Not commercially available.

Packaging and storage:
Store between 2 and 25 °C (36 and 77 °F) {20}.

Preparation of dosage form:
The bottle should be tapped to loosen the powder. The total volume of water indicated below should be added in two portions, shaking well after each addition {20}.


Final concentration  Bottle size  Total amount of water 
90 mg/5 mL  30 mL   28 mL 
60 mL  53 mL 
90 mL  78 mL 
120 mL  103 mL 
180 mg/5 mL  30 mL  28 mL 
60 mL  53 mL 
120 mL  103 mL 

Stability:
After reconstitution, the suspension may be stored for up to 14 days between 2 and 8 °C (36 and 46 °F) {20}.

Auxiliary labeling:
   • Refrigerate.
   • Shake well.
   • Take on an empty stomach, at least 2 hours before or 1 hour after meals.
   • Continue medicine for full time of treatment.
   • Beyond-use date.


CEFTIZOXIME

Summary of Differences
Category: Third-generation cephalosporin.

Precautions:

• Pediatrics—Associated with transient elevation in eosinophils, ALT (SGPT), AST (SGOT), and CK.



Additional Dosing Information
Intramuscular doses of 2 grams should be administered as divided doses in different sites.


Parenteral Dosage Forms

Note: The dosing and strengths of the dosage forms available are expressed in terms of ceftizoxime base (not the sodium salt).

CEFTIZOXIME INJECTION USP

Usual adult and adolescent dose
Pelvic inflammatory disease 1
Intravenous infusion, 2 grams (base) every eight hours {21}.

Urinary tract infections, uncomplicated
Intravenous infusion, 500 mg (base) every twelve hours {21}.

For all other infections
Mild to moderate: Intravenous infusion, 1 gram (base) every eight to twelve hours {21}.

Severe or refractory: Intravenous infusion, 1 gram (base) every eight hours; or 2 grams every eight to twelve hours {21}.

Life-threatening: Intravenous infusion, 3 to 4 grams (base) every eight hours {21}.


Note: Dosages of up to 2 grams every four hours have been given for life-threatening infections {21}.
After an initial loading dose of 500 mg to 1 gram (base), adults with impaired renal function may require a reduction in dose as follows {21}:

Creatinine clearance (mL/min)/(mL/sec)  Dose (base) 
Less severe infections  Life-threatening infections 
³80/1.33  See Usual adult and
adolescent dose

See Usual adult and
adolescent dose

50–79/0.83–1.32  500 mg
every 8 hours 
750 mg to 1.5 grams
every 8 hours 
5–49/0.08–0.82  250 to 500 mg
every 12 hours 
500 mg to 1 gram
every 12 hours 
0–4/0–0.07  500 mg every 48 hours; or 250 mg every 24 hours  500 mg to 1 gram every 48 hours; or 500 mg every 24 hours 



Usual pediatric dose
For bacterial infections
Children 6 months of age and older: Intravenous infusion, 50 mg (base) per kg of body weight every six to eight hours {21}.

Infants up to 6 months of age: Safety and efficacy have not been established {21}.


Usual pediatric prescribing limits
200 mg (base) per kg of body weight (not to exceed the maximum adult dose for serious infection) {21}.

Usual geriatric dose
See Usual adult and adolescent dose .

Usual geriatric prescribing limits
1.5 grams (base) for patients older than seventy-five years of age, even if serum creatinine concentrations are normal {145}.

Strength(s) usually available
U.S.—


1 gram (base) per 50 mL (Rx) [Cefizox (sodium 2.6 mEq per gram)]{21}


2 grams (base) per 50 mL (Rx) [Cefizox (sodium 2.6 mEq per gram)]{21}

Canada—
Not commercially available.

Packaging and storage:
Store between –25 and –10 °C (–13 and 14 °F), unless otherwise specified by manufacturer.

Preparation of dosage form:
The container should be thawed at room temperature (25 °C [77 °F]) or under refrigeration (5 °C [41 °F]) before administration, making sure that all ice crystals have melted. Thawing should not be forced by immersion in water baths or by microwave irradiation. {21}

Do not use minibags in series connections. This may result in air embolism because of residual air being drawn from the primary container before administration of intravenous solution from the secondary container is complete. {21}

Stability:
After thawing, solutions retain their potency for 48 hours at room temperature or for 28 days if refrigerated at 5 °C (41 °F). Once thawed, solutions should not be refrozen. {21}

Do not use if the solution is cloudy or contains a precipitate. {21}

Incompatibilities:
The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle.


CEFTIZOXIME FOR INJECTION USP

Usual adult and adolescent dose
Gonorrhea, uncomplicated 1
Intramuscular, 1 gram (base) as a single dose {22}.

Pelvic inflammatory disease 1
Intravenous, 2 grams (base) every eight hours {22}.

Urinary tract infections, uncomplicated
Intramuscular or intravenous, 500 mg (base) every twelve hours {22} {72}.

For all other infections
Mild to moderate: Intramuscular or intravenous, 1 gram (base) every eight to twelve hours {22} {72}.

Severe or refractory: Intramuscular or intravenous, 1 gram (base) every eight hours; or 2 grams every eight to twelve hours {22} {72}.

Life-threatening: Intravenous, 3 to 4 grams (base) every eight hours {22} {72}.


Note: Dosages of up to 2 grams (base) every four hours have been given for life-threatening infections {22}.
Adults with renal function impairment may require a reduction in dose {22} {72}. See Ceftizoxime Injection USP .


Usual pediatric dose
For bacterial infections
Children 6 months to 12 years of age: Intramuscular or intravenous, 50 mg (base) per kg of body weight every six to eight hours {22} {72}.

Infants and children up to 6 months of age: Safety and efficacy have not been established {22}.


Usual pediatric prescribing limits
See Ceftizoxime Injection USP .

Usual geriatric dose
See Usual adult and adolescent dose .

Usual geriatric prescribing limits
See Ceftizoxime Injection USP .

Strength(s) usually available
U.S.—


500 mg (base) (Rx) [Cefizox (sodium 2.6 mEq per gram)]{22}


1 gram (base) (Rx) [Cefizox (sodium 2.6 mEq per gram)]{22}


2 grams (base) (Rx) [Cefizox (sodium 2.6 mEq per gram)]{22}


10 grams (base) (Rx) [Cefizox (sodium 2.6 mEq per gram)]{22}

Canada—


1 gram (base) (Rx) [Cefizox (sodium 2.6 mEq per gram)]{72}


2 grams (base) (Rx) [Cefizox (sodium 2.6 mEq per gram)]{72}

Packaging and storage:
Prior to reconstitution, store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from excess light.

Preparation of dosage form:
To prepare initial dilution for intramuscular use, 1.5, 3, or 6 mL of sterile water for injection should be added to each 500-mg, 1-gram, or 2-gram vial, respectively. {22}

To prepare initial dilution for intravenous use, 5, 10, or 20 mL of sterile water for injection should be added to each 500-mg, 1-gram, or 2-gram vial, respectively. For direct intravenous use, the resulting solution should be administered slowly over a 3- to 5-minute period. For continuous or intermittent infusions, the resulting solution should be further diluted in 50 to 100 mL of suitable fluids (see manufacturer's package insert). {22}

For reconstitution of piggyback infusion bottles and pharmacy bulk vials, see manufacturer's labeling for instructions.

Stability:
After reconstitution for intramuscular or intravenous use with suitable diluents (see manufacturer's package insert), solutions retain their potency for 24 hours at room temperature or for 48 to 96 hours (see manufacturer's package insert) if refrigerated at 5 °C (41 °F). {22}

Solutions may vary in color from yellow to amber. This does not affect their potency. {22}

Incompatibilities:
The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle.

Additional information:
A solution containing 1 gram in 13 mL of sterile water for injection is isotonic. {22}


CEFTRIAXONE

Summary of Differences
Category: Third-generation cephalosporin.

Pharmacology/pharmacokinetics: Long half-life; may be dosed once a day.

Precautions:

• Pediatrics—Should be used with caution when administered to hyperbilirubinemic neonates, especially premature neonates.


• Drug interactions and/or related problems—Does not interact with probenecid.


Side/adverse effects: Associated with “biliary sludge” or pseudolithiasis.


Additional Dosing Information
Patients with impaired hepatic function do not generally require a reduction in dose. However, in patients with both impaired hepatic and renal function, the daily dose should not exceed 2 grams.

Intravenous infusion should be administered over a period of 30 minutes.


Parenteral Dosage Forms

Note: The dosing and strengths of the dosage forms available are expressed in terms of ceftriaxone base (not the sodium salt).

CEFTRIAXONE INJECTION USP

Usual adult and adolescent dose
Perioperative prophylaxis
Intravenous infusion, 1 gram (base) one-half to two hours prior to the start of surgery{23}.

For all other infections
Intravenous infusion, 1 to 2 grams (base) every twenty-four hours; or 500 mg to 1 gram every twelve hours{23}.


Usual adult and adolescent prescribing limits
4 grams (base) per day{23}.

Usual pediatric dose
Meningitis
Intravenous infusion, 100 mg (base) per kg of body weight, up to 4 grams, on the first day; then 100 mg per kg of body weight every twenty-four hours, or 50 mg per kg of body weight every twelve hours, up to 4 grams per day, for seven to fourteen days {23}.

Skin and soft tissue infections
Intravenous infusion, 50 to 75 mg (base) per kg of body weight every twenty-four hours, or 25 to 37.5 mg per kg of body weight every twelve hours, up to 2 grams per day {23}.

For all other infections, serious
Intravenous infusion, 25 to 37.5 mg (base) per kg of body weight every twelve hours, up to 2 grams per day {23}.


Usual pediatric prescribing limits
4 grams (base) per day for meningitis, and 2 grams per day for all other infections {23}.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


1 gram (base) in 50 mL (Rx) [Rocephin (sodium 3.6 mEq per gram)]{23}


2 grams (base) in 50 mL (Rx) [Rocephin (sodium 3.6 mEq per gram)]{23}

Canada—
Not commercially available.

Packaging and storage:
Store between –25 and –10 °C (–13 and 14 °F), unless otherwise specified by manufacturer.

Preparation of dosage form:
The container should be thawed at room temperature before administration, making sure that all ice crystals have melted. {23}

Do not use minibags in series connections. This may result in air embolism because of residual air being drawn from the primary container before administration of intravenous solution from the secondary container is complete. {23}

Stability:
Once thawed, solutions should not be refrozen. {23}

Do not use if the solution is cloudy or contains a precipitate. {23}

Incompatibilities:
The admixture of ceftriaxone with other medications, including pentamidine isethionate {82}, or with labetalol hydrochloride {43} is not recommended. {23}

The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle.

The admixture of ceftriaxone and vancomycin and fluconazole are physically incompatible. When concomitantly administering ceftriaxone by intermittent intravenous infusion it is recommended that they be given sequentially, with thorough flushing of the intravenous lines (with one of the compatible fluids) between administrations.
{174}

CEFTRIAXONE FOR INJECTION USP

Usual adult and adolescent dose
Gonorrhea, uncomplicated
Intramuscular, 250 mg (base) as a single dose {23} {73}.

Perioperative prophylaxis
Intravenous, 1 gram (base) one-half to two hours prior to the start of surgery {23} {73}.

For all other infections
Intramuscular or intravenous, 1 to 2 grams (base) every twenty-four hours; or 500 mg to 1 gram every twelve hours {23} {73}.


Usual adult prescribing limits
See Ceftriaxone Injection USP .

Usual pediatric dose
Meningitis
Intramuscular or intravenous, 100 mg (base) per kg of body weight, up to 4 grams, on the first day; then 100 mg per kg of body weight every twenty-four hours, or 50 mg per kg of body weight every twelve hours, up to 4 grams per day, for seven to fourteen days {23}.

Otitis media1
Intramuscular, 50 mg (base) per kg of body weight, up to 1 gram, as a single dose {23}.

Skin and soft tissue infections
Intramuscular or intravenous, 50 to 75 mg (base) per kg of body weight every twenty-four hours, or 25 to 37.5 mg per kg of body weight every twelve hours, up to 2 grams per day {23}.

For all other serious infections
Intramuscular or intravenous, 25 to 37.5 mg (base) per kg of body weight every twelve hours, up to 2 grams per day {23} {73}.


Usual pediatric prescribing limits
See Ceftriaxone Injection USP .

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


250 mg (base) (Rx) [Rocephin (sodium 3.6 mEq per gram)]{23}


500 mg (base) (Rx) [Rocephin (sodium 3.6 mEq per gram)]{23}


1 gram (base) (also available in ADD-Vantage® vials) (Rx) [Rocephin (sodium 3.6 mEq per gram)]{23}


2 grams (base) (also available in ADD-Vantage® vials) (Rx) [Rocephin (sodium 3.6 mEq per gram)]{23}


10 grams (base) (Rx) [Rocephin (sodium 3.6 mEq per gram)]{23}

Canada—


250 mg (base) (Rx) [Rocephin (sodium 3.6 mEq per gram)]{73}


1 gram (base) (also available in ADD-Vantage® vials) (Rx) [Rocephin (sodium 3.6 mEq per gram)]{73}


2 grams (base) (Rx) [Rocephin (sodium 3.6 mEq per gram)]{73}


10 grams (base) (Rx) [Rocephin (sodium 3.6 mEq per gram)]{73}

Packaging and storage:
Prior to reconstitution, store below 25 °C (77 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from light.

Preparation of dosage form:
To prepare initial dilution for intramuscular use, 0.9 mL of sterile water for injection, 0.9% sodium chloride injection, 5% dextrose injection, bacteriostatic water for injection (with 0.9% benzyl alcohol), or 1% lidocaine hydrochloride injection (without epinephrine) should be added to each 250-mg vial, 1.8 mL of diluent should be added to each 500-mg vial, 3.6 mL of diluent should be added to each 1-gram vial, or 7.2 mL of diluent should be added to each 2-gram vial to provide a concentration of approximately 250 mg per mL {23}. Alternatively, to reduce the volume of intramuscular injection, a solution of 350 mg per mL may be prepared by adding 1 mL of diluent to each 500-mg vial, 2.1 mL of diluent to each 1-gram vial, or 4.2 mL of diluent to each 2-gram vial {23}. The 350-mg-per-mL solution is bioequivalent to a 250-mg-per-mL solution {51}.

To prepare initial dilution for intravenous use, 2.4 mL of appropriate diluent (see manufacturer's package insert) should be added to each 250-mg vial, 4.8 mL of diluent should be added to each 500-mg vial, 9.6 mL of diluent should be added to each 1-gram vial, or 19.2 mL of diluent should be added to each 2-gram vial to provide a concentration of approximately 100 mg per mL. The reconstituted solution may be further diluted to 50 or 100 mL with an appropriate diluent for intravenous infusion. {23}

For reconstitution of piggyback infusion bottles and pharmacy bulk vials, see manufacturer's labeling for instructions.

Caution—Use of diluents containing benzyl alcohol is not recommended for preparation of medications for use in neonates. A fatal toxic syndrome consisting of metabolic acidosis, CNS depression, respiratory problems, renal failure, hypotension, and possibly seizures and intracranial hemorrhages has been associated with this use.

Stability:
After reconstitution for intramuscular use, solutions retain at least 90% of their potency for 1 to 3 days at room temperature (25 °C [77 °F]) or for 3 to 10 days if refrigerated at 4 °C (39 °F), depending on concentration and diluent. {23}

After reconstitution for intravenous use, solutions retain at least 90% of their potency for 3 days at room temperature (25 °C [77 °F]) or for 10 days if refrigerated at 4 °C (39 °F), when stored in glass or polyvinyl chloride (PVC) containers in suitable diluents (see manufacturer's package insert). {23}

After reconstitution for intravenous use with 5% dextrose injection or 0.9% sodium chloride injection, solutions at concentrations of 10 to 40 mg per mL retain their potency for 26 weeks at -20 °C (-4 °F) when stored in PVC or polyolefin containers. Frozen solutions should be thawed at room temperature. Once thawed, solutions should not be refrozen. {23}

Solutions may vary in color from light yellow to amber, depending on length of time in storage, concentration, and diluent. {23}

Incompatibilities:
The admixture of ceftriaxone with other medications, including pentamidine isethionate {82}, or with labetalol hydrochloride {43} is not recommended. {23}

The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle.

The admixture of ceftriaxone and vancomycin and fluconazole are physically incompatible. When concomitantly administering ceftriaxone by intermittent intravenous infusion it is recommended that they be given sequentially, with thorough flushing of the intravenous lines (with one of the compatible fluids) between administrations.
{174}

CEFUROXIME

Summary of Differences
Category: Second-generation cephalosporin.

Pharmacology/pharmacokinetics:

• Cefuroxime oral suspension reaches only 91% of the area under the plasma concentration–time curve (AUC) and 71% of the peak serum concentration that cefuroxime tablets reach.


• Parenteral cefuroxime is the only second-generation cephalosporin to adequately penetrate into the CSF; however, sterilization is delayed compared with third-generation cephalosporins.


Precautions:

• Laboratory value alteration—May give false-positive test results with Coombs' test, copper reduction tests (including Benedict's solution, Clinitest®, and Fehling's solution) ; a false negative for ferricyanide blood glucose test .and a fall in prothrombin levels



Additional Dosing Information
For oral dosage forms only:
   • Cefuroxime axetil tablets may be given without regard to meals; however, absorption is enhanced when they are given with food.
   • Cefuroxime axetil oral suspension should be taken with food.
   • Cefuroxime axetil tablets and oral suspension are not bioequivalent and are not substitutable on a mg-per-mg basis.


Oral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

The dosing and strengths of the dosage forms available are expressed in terms of cefuroxime base (not the axetil salt).

CEFUROXIME AXETIL FOR ORAL SUSPENSION

Usual adult and adolescent dose
The oral suspension usually is used only for children. See Cefuroxime Axetil Tablets USP .

Usual pediatric dose
Impetigo1 or
Otitis media, acute or
Sinusitis, acute bacterial maxillary
Infants and children 3 months to 12 years of age: Oral, 15 mg (base) per kg of body weight every twelve hours, up to 1000 mg per day, for ten days {24} {74}.

Infants up to 3 months of age: Safety and efficacy have not been established {174}{24} {74}.

Pharyngitis or
Tonsillitis
Infants and children 3 months to 12 years of age: Oral, 10 mg (base) per kg of body weight every twelve hours, up to 500 mg per day, for ten days {24} {74}.

Infants up to 3 months of age: Safety and efficacy have not been established {24} {74}.


Usual pediatric prescribing limits
500 mg per day for pharyngitis and tonsillitis, and 1000 mg per day for impetigo otitis media and sinusitis {174} {24} {74}.

Strength(s) usually available
U.S.—


125 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 50- and 100-mL bottles) (Rx) [Ceftin (sucrose )]{24}


250 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 50- and 100-mL bottles) (Rx) [Ceftin (sucrose )]{24}

Canada—


125 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 70- and 100-mL bottles) (Rx) [Ceftin (sucrose )]{74}


250 mg single dose packets (Rx) [Ceftin (sucrose)]{74}

Packaging and storage:
Prior to reconstitution, store between 2 and 30 °C (36 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Preparation of dosage form:
Cefuroxime axetil should not be reconstituted with milk, hot water, or other hot fluids. {74}

For the oral suspension—The bottle should be shaken to loosen the powder. The total amount of water for reconstitution should be added as indicated below. The solution should be shaken vigorously to reconstitute {24} {74}.


Final concentration  Labeled volume after reconstitution  Total volume of water to be added 
125 mg/5 mL  50 mL  20 mL 
70 mL  27 mL 
100 mL  37 mL 
250 mg/5 mL   50 mL  19 mL 
100 mL  35 mL 
For the single dose packets—Empty the contents of the packet into a glass. Add 10 mL or more of cold water; apple, grape, or orange juice; or lemonade. Stir well and consume the entire volume immediately. {74}

Stability:
After reconstitution, suspension retains its potency for 10 days if refrigerated or stored at room temperature (between 2 and 25 °C [36 and 77 °F]). {24}

Auxiliary labeling:
   • Take with food.
   • Does not require refrigeration.
   • Continue medicine for full time of treatment.
   • Shake well.
   • Beyond-use date.

Note: When dispensing, include a calibrated liquid-measuring device.



CEFUROXIME AXETIL TABLETS USP

Usual adult and adolescent dose
Bronchitis, bacterial exacerbations1or
Skin and soft tissue infections
Oral, 250 or 500 mg (base) two times a day for ten days {24} {74}.

Bronchitis
Oral, 250 or 500 mg (base) two times a day for five to ten days {24}.

Gonorrhea, uncomplicated
Oral, 1000 mg (base) as a single dose {24} {74}.

Lyme disease, early1
Oral, 500 mg (base) two times a day for twenty days {24}.

Pharyngitis or
Sinusitis, acute maxillary or
Tonsillitis
Oral, 250 mg (base) two times a day for ten days {24} {74}.

[Pneumonia]
Oral, 500 mg (base) two times a day {74}.

Urinary tract infections, uncomplicated1
Oral, 250 mg (base) two times a day for seven to ten days {24}.


Usual pediatric dose
Otitis media, acute or
Sinusitis, acute bacterial maxillary
Children who can swallow tablets whole: Oral, 250 mg (base) two times a day for ten days {174}{24}.

Children who cannot swallow tablets whole: See Cefuroxime Axetil for Oral Suspension .

Pharyngitis or
Tonsillitis
Children who can swallow tablets whole: Oral,250mg (base) two times a day for ten days {24}.

Children who cannot swallow tablets whole: See Cefuroxime Axetil for Oral Suspension .


Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


250 mg (base) (Rx) [Ceftin (methylparaben) (propylparaben)]{24}


500 mg (base) (Rx) [Ceftin (methylparaben) (propylparaben)]{24}{180}

Canada—


250 mg (base) (Rx) [Ceftin (methylparaben) (propylparaben)]{74}


500 mg (base) (Rx) [Ceftin (methylparaben) (propylparaben)]{74}

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Continue medicine for full time of treatment.



Parenteral Dosage Forms

Note: The dosing and strengths of the dosage forms available are expressed in terms of cefuroxime base (not the sodium salt).

CEFUROXIME INJECTION USP

Usual adult and adolescent dose
General dose
Intravenous, 750 mg to 1.5 gm of cefuroxime every 8 hours, usually for 5 to 10 days.{178} Canadian product information states usual duration of treatment is for 5 to 14 days.{177}.

Bone and joint infections (treatment)
Gonococcal infections, disseminated, severe or complicated (treatment)1
Pneumonia, severe or complicated (treatment)
Skin and skin-structure infections, severe or complicated (treatment),1
Urinary tract infections, severe or complicated (treatment)1
Intravenous infusion, 1.5 grams (base) every eight hours {26}.{177}{178}

Gonococcal infections, disseminated1 or
Pneumonia, uncomplicated or
Skin and soft tissue infections or
Urinary tract infections, uncomplicated
Intravenous infusion, 750 mg (base) every eight hours {26}.

Meningitis, bacterial
Intravenous infusion, up to 3 grams (base) every eight hours {26}.

Perioperative prophylaxis
Open heart surgery patients: Intravenous infusion, 1.5 grams (base) at the induction of anesthesia, then 1.5 grams every twelve hours, for a total of 6 grams {26}.

Other surgery patients: Intravenous infusion, 1.5 grams (base) one-half to one hour prior to the start of surgery, then 750 mg every eight hours thereafter {26}.

For all other infections
Life-threatening or less susceptible organisms: Intravenous infusion, 1.5 grams (base) every six hours.{26}{178} Canadian product information states for severe or life threatening infections, intravenous 1.5 gm every 8 hours (4.5 gm per day){177}.


Note: Adults with impaired renal function may require a reduction in dose as follows {26}:

Creatinine clearance
(mL/min)/(mL/sec) 
Dose (base) 
> 20/0.33  750 mg to 1.5 grams every 8 hours 
10–20/0.17–0.33  750 mg every 12 hours 
< 10/0.17  750 mg every 24 hours  
Hemodialysis patients   750 mg at the end of each dialysis period 



Usual adult prescribing limits
Bacterial Meningitis-Up to 3 gm of cefuroxime every 8 hours.{178}

Usual pediatric dose
General dose
For those three months of age and older: Intravenous, 50 to 150 mg per kg of body weight per day in equally divided doses every 6 to 8 hours. A higher dosage of 100 mg per kg of body weight per day (not to exceed the maximum adult dosage) should be used for the more severe or serious infections.{178}
[Neonates (up to 1 month of age)]Intravenous, 30 to 100 mg per kg of body weight per day in 2 or 3 equally divided doses. Note that in the first few weeks of life, the serum half-life of cefuroxime can be 3 to 5 times that in adults.{177}

[ Infants and children (1 month to 12 years)]Intravenous, 30 to 100 mg per kg of body weight per day in 3 or 4 equally divided doses. A dose of 60 mg per kg of body weight per day is appropriate for most infections.{177}

Note: Pediatric patients with renal insufficiency the frequency of dosing should be modified consistent with the recommendations for adults.{178}


Bone and joint infections (treatment)
For those three months of age and older—Intravenous, 150 mg per kg of body weight per day (not exceeding the maximum adult dosage) in equally divided doses every 8 hours. In clinical trials a course of oral antibiotics was administered to pediatric patients following the completion of parenteral administration{178}

[Infants and children (1 month to 12 years)]Intravenous, 70 to 150 mg per kg of body weight per day every 8 hours. In clinical trials a course of oral antibiotics was administered to pediatric patients following the completion of parenteral administration{177}

Meningitis, bacterial (treatment)
For those 3 months of age and older—Intravenous, 200 to 240 mg per kg of body weight per day in equally divided doses every 6 to 8 hours.{178}

[Infants and children (1 month to 12 years)]Intravenous, 200 to 240 mg per kg of body weight per day in 3 or 4 equally divided doses.{177}

[Neonates (up to 1 month of age)]Intravenous, 100 mg per kg of body weight per day in 2 or 3 equally divided doses.{177}


Note: Pediatric patients with impaired renal function may require a reduction in the frequency of dosing consistent with adult dosing recommendations in renal impairment {26}. See Usual adult and adolescent dose .


Usual pediatric prescribing limits
Up to the maximal adult dosage for the indication. {26}See Usual adult prescribing limits.

Usual geriatric dose
See Usual adult and adolescent dose

Strength(s) usually available
U.S.—


750 mg as frozen, iso-osmotic, sterile, nonpyrogenic solution in a plastic container (Rx) [Zinacef (Dextrose Hydrous, USP 1.4 gm) (Sodium Citrate Hydrous, USP 300 mg) (sodium 111 mg (4.8 mEq)) (hydrochloric acid) (sodium hydroxide)]{178}


1.5 gm as frozen, iso-osmotic, sterile, nonpyrogenic solution in a plastic container (Rx) [Zinacef (Sodium Citrate Hydrous, USP 600 mg) (sodium 222 mg (9.7 mEq)) (hydrochloric acid) (sodium hydroxide )]{178}

Note: The plastic container is fabricated from a specially designed multilayer plastic, PL 2040. Solutions are in contact with polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.{178}


Canada—
Not commercially available.

Packaging and storage:
Store frozen below -20° C{178}

Preparation of dosage form:
The container should be thawed at room temperature (25 °C [77 °F]) or under refrigeration (5 °C [41 °F]) before administration, making sure that all ice crystals have melted. Thawing should not be forced by immersion in water baths or by microwave irradiation. {26}Do not force thaw by immersion in water baths or by microwave irradiation{178}

Do not use minibags in series connections. This may result in air embolism because of residual air being drawn from the primary container before administration of intravenous solution from the secondary container is complete. {26}

Mix after solution has reached room temperature. Check or minute leaks by squeezing bag firmly. Discard bag if leaks are found as sterility may be impaired. {178}

Do not add supplementary medication.{178}.

Do not use unless solution is clar and seal is intact.{178}

Stability:
After thawing, solutions retain their potency for 24 hours at room temperature or for 28 days if refrigerated at 5 °C (41 °F). Once thawed, solutions should not be refrozen. {26}

Do not use if the solution is cloudy or contains a precipitate. {26}

Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected{178}.

Solution ranges in color from light yellow to amber. {26}

Incompatibility
The admixture of cefuroxime with other antibacterials is not recommended. {26}

The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle.


CEFUROXIME FOR INJECTION USP

Usual adult and adolescent dose
General dose
Intravenous or intramuscular, 750 mg to 1.5 gm of cefuroxime every 8 hours, usually for 5 to 10 days.{178} Canadian product information states usual duration of treatment is for 5 to 14 days.{177}.

Bone and joint infections (treatment) or
Gonococcal infections, disseminated, severe or complicated (treatment)1 or
Pneumonia, severe or complicated (treatment) or
Skin and skin-structure infections, severe or complicated (treatment), 1 or
Urinary tract infections, severe or complicated (treatment)1
Intramuscular or intravenous, 1.5 grams (base) every eight hours {25} {26} {58}{177}{178}.

Gonococcal infections, disseminated1 or
Pneumonia, uncomplicated or
Skin and soft tissue infections or
Urinary tract infections, uncomplicated
Intramuscular or intravenous, 750 mg (base) every eight hours {25} {26} {58}.

Gonorrhea, uncomplicated
Intramuscular, 1.5 grams (base) as a single dose at two different sites, in combination with 1 gram of oral probenecid {25} {26}.

Meningitis, bacterial
Intravenous, up to 3 grams (base) every eight hours {25} {26} {58}.

Perioperative prophylaxis
Open heart surgery patients: Intravenous, 1.5 grams (base) at the induction of anesthesia, then 1.5 grams every twelve hours, for a total of 6 grams {25} {26} {58}.

Other surgery patients: Intravenous, 1.5 grams (base) one-half to one hour prior to the start of surgery, then 750 mg (intramuscularly or intravenously) every eight hours thereafter {25} {26} {58}.

In Canada after surgery, 750 mg intravenously or intramuscularly at 8 hours and 16 hours when the procedure is prolonged. Continued prophylactic administration of any antibiotic does not appear to be associated with a reduced incidence of subsequent infection, but will increase the possibility of adverse reactions and the development of bacterial resistance.{177}

For all other infections
Severe or complicated: Intramuscular or intravenous, 1.5 grams (base) every eight hours {25} {26} {58}.

Life-threatening or less susceptible organisms: Intramuscular or intravenous, 1.5 grams (base) every six hours {25} {26}.{178}. Canadian product information states for severe or life threatening infections, intravenous 1.5 gm every 8 hours (4.5 gm per day){177}


Note: Adults with renal function impairment may require a reduction in dose {25} {26} {58}. See Cefuroxime Sodium Injection USP .


Usual adult prescribing limits
Bacterial Meningitis-Up to 3 gm of cefuroxime every 8 hours.{178}

Usual pediatric dose
General dose
For those three months of age and older: Intravenous, 50 to 150 mg per kg of body weight per day in equally divided doses every 6 to 8 hours. A higher dosage of 100 mg per kg of body weight per day (not to exceed the maximum adult dosage) should be used for the more severe or serious infections.{178}
[Neonates (up to 1 month of age)]Intravenous, 30 to 100 mg per kg of body weight per day in 2 or 3 equally divided doses. Note that in the first few weeks of life, the serum half-life of cefuroxime can be 3 to 5 times that in adults.{177}

[ Infants and children (1 month to 12 years)]Intravenous, 30 to 100 mg per kg of body weight per day in 3 or 4 equally divided doses. A dose of 60 mg per kg of body weight per day is appropriate for most infections.{177}

Note: Pediatric patients with renal insufficiency the frequency of dosing should be modified consistent with the recommendations for adults.{178}


Bone and joint infections (treatment)
For those three months of age and older—Intravenous, 150 mg per kg of body weight per day (not exceeding the maximum adult dosage) in equally divided doses every 8 hours. In clinical trials a course of oral antibiotics was administered to pediatric patients following the completion of parenteral administration{178}

[Infants and children (1 month to 12 years)]Intravenous, 70 to 150 mg per kg of body weight per day every 8 hours. In clinical trials a course of oral antibiotics was administered to pediatric patients following the completion of parenteral administration{177}

Meningitis, bacterial (treatment)
For those 3 months of age and older—Intravenous, 200 to 240 mg per kg of body weight per day in equally divided doses every 6 to 8 hours.{178}

[Infants and children (1 month to 12 years)]Intravenous, 200 to 240 mg per kg of body weight per day in 3 or 4 equally divided doses.{177}

[Neonates (up to 1 month of age)]Intravenous, 100 mg per kg of body weight per day in 2 or 3 equally divided doses.{177}


Note: Pediatric patients with renal function impairment may require a reduction in the frequency of dosing consistent with adult dosing recommendations in renal impairment {25} {26}. See Cefuroxime Sodium Injection USP .


Usual pediatric prescribing limits
Up to the maximal adult dosage for the indication. {178}See Cefuroxime Injection USP, Usual adult prescribing limits .

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—

Note: Zinacef contains 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity.{178}



750 mg (also may be available in ADD-Vantage® vials) (Rx) [Kefurox (sodium 2.4 mEq per gram)]{25} [Zinacef (sodium 2.4 mEq per gram)]{26}[Generic]


1.5 grams (also may be available in ADD-Vantage® vials) (Rx) [Kefurox (sodium 2.4 mEq per gram)]{25} [Zinacef (sodium 2.4 mEq per gram)]{26}[Generic]


7.5 grams (Rx) [Kefurox (sodium 2.4 mEq per gram)]{25} [Zinacef (sodium 2.4 mEq per gram)]{26}[Generic]


750 mg infusion pack (Rx) [Zinacef ( sodium)]{178}


1.5 gm infusion pack (Rx) [Zinacef ( sodium)]{178}

Canada—


750 mg (also may be available in ADD-Vantage® vials) (Rx) [Kefurox (sodium 2.4 mEq per gram)]{58} [Zinacef]{75}


1.5 grams (also may be available in ADD-Vantage® vials) (Rx) [Kefurox (sodium 2.4 mEq per gram)]{58} [Zinacef]{75}{177}


7.5 grams (Rx) [Kefurox (sodium 2.4 mEq per gram)]{58} [Zinacef]{75}{177}

Packaging and storage:
Prior to reconstitution, store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from light.

When frozen, store at or below -4°F ( -20°C){178}

Preparation of dosage form:
To prepare initial dilution for intramuscular use, 3 or 3.6 mL of sterile water for injection (see manufacturer's labeling instructions) should be added to each 750-mg vial and the entire volume withdrawn to provide a concentration of approximately 220 mg per mL. {25} {26}

To prepare initial dilution for intravenous use, see manufacturer's labeling instructions. For direct intermittent intravenous use, the resulting solution should be administered slowly over a 3- to 5-minute period. For infusion, each 750-mg or 1.5-gram dose may be diluted with 50 to 100 mL of appropriate diluent (see manufacturer's package insert). {25} {26}

For reconstitution of piggyback infusion bottles and pharmacy bulk vials, see manufacturer's labeling for instructions. If the Y-type method of administration is used, the primary infusion should be temporarily discontinued during infusion of cefuroxime. {25} {26}

Stability:
After reconstitution for intramuscular use, suspensions retain their potency for 24 hours at room temperature or for 48 hours if refrigerated at 5 °C (41 °F). {25} {26}

ADD-Vantage diluent containers and activated to dissolve the drug are stable for 24 hours at room temperature or for 7 days under refrigeration (5° C). Joined vials that have not been activated may be used within a 14 day period. Freezing solutions in the ADD-Vantage system is not recommended.{178}

After reconstitution for intravenous use, solutions retain their potency for 24 hours at room temperature or for 48 hours if refrigerated at 5 °C (41 °F) {25} {26}. The 7.5 gm bulk containers are stable for 24 hours at room temperature and 7 days under refrigeration (5° C){178} Solutions stored in polyvinyl chloride (PVC) minibags in 50 or 100 mL of 5% dextrose injection or 0.9% sodium chloride injection retain their potency for 6 months at -20 °C (-4 °F) {26}.

Frozen solutions should be thawed at room temperature. Thawing should not be forced by immersion in water baths or by microwave irradiation. Thawed solutions retain their potency for up to 24 hours at room temperature or for 7 days if refrigerated. {26}

Intravenous infusions at concentrations of 7.5 and 15 mg per mL in sterile water for injection, 5% dextrose injection, or 0.9% sodium chloride injection retain their potency for 24 hours at room temperature or for 7 days if refrigerated {25} {26}. Use of sodium bicarbonate is not recommended for dilution {26}.

Solutions may vary in color from light yellow to amber, depending on concentration and diluent. In addition, cefuroxime powder, suspensions, and solutions tend to darken, depending on storage conditions. This does not affect their potency. {25} {26}

Incompatibility
The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle. {25} {26}

Sodium Bicarbonate Injection USP is not recommended for the dilution of cefuroxime.{178}


CEPHALEXIN

Summary of Differences
Category: First-generation cephalosporin.


Additional Dosing Information
When daily doses greater than 4 grams are required, parenteral cephalosporins should be considered.

No dosage adjustment is necessary for renal function impairment.


Oral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

CEPHALEXIN CAPSULES USP

Usual adult and adolescent dose
Cystitis, uncomplicated or
Pharyngitis or
Skin and soft tissue infections or
Tonsillitis
Oral, 500 mg every twelve hours {27}.

Note: Treatment of cystitis should be administered only to adults and adolescents 15 years of age and older, and should continue for seven to fourteen days {27}.


[Endocarditis, prophylaxis]1
Oral, 2 grams as a single dose one hour prior to the start of surgery {31}.

For all other infections
Mild to moderate: Oral, 250 mg every six hours {27}.

Severe: Oral, up to 1 gram every six hours {27}.


Usual adult prescribing limits
4 grams per day {27}.

Usual pediatric dose
This dosage form usually is not used for children. See Cephalexin for Oral Suspension USP .

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


250 mg (Rx) [Keflex]{27}[Generic]


500 mg (Rx) [Keflex]{27}[Generic]

Canada—


250 mg (Rx) [Novo-Lexin]{76}


500 mg (Rx) [Novo-Lexin]{76}

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from light.

Auxiliary labeling:
   • Continue medicine for full time of treatment.


CEPHALEXIN FOR ORAL SUSPENSION USP

Usual adult and adolescent dose
See Cephalexin Capsules USP .

Usual adult prescribing limits
See Cephalexin Capsules USP .

Usual pediatric dose
[Endocarditis, prophylaxis]1
Children over 40 kg of body weight: See Usual adult and adolescent dose .

Children 1 year of age and older, and up to 40 kg of body weight: Oral, 50 mg per kg of body weight one hour prior to the start of surgery {31}.

[Impetigo ]1
Oral, 15 mg per kg of body weight three times per day for ten days {156}.

Otitis media
Children over 40 kg of body weight: See Usual adult and adolescent dose .

Children 1 year of age and older, and up to 40 kg of body weight: Oral, 18.75 to 25 mg per kg of body weight every six hours {27}.

Pharyngitis or
Skin and soft tissue infections or
Tonsillitis
Children over 40 kg of body weight: See Usual adult and adolescent dose .

Children 1 year of age and older, and up to 40 kg of body weight: Oral, 12.5 to 25 mg per kg of body weight every twelve hours {27}.

For all other infections
Children over 40 kg of body weight: See Usual adult and adolescent dose .

Children 1 year of age and older, and up to 40 kg of body weight:


Mild to moderate—Oral, 12.5 to 25 mg per kg of body weight every twelve hours; or 6.25 to 12.5 mg per kg of body weight every six hours {27}.


Severe—Oral, 25 to 50 mg per kg of body weight every twelve hours; or 12.5 to 25 mg per kg of body weight every six hours {27}.

Infants and children 1 month to 1 year of age: Oral, 6.25 to 12.5 mg per kg of body weight every six hours {140}.


Usual pediatric prescribing limits
2 grams for prophylaxis of bacterial endocarditis {153}.

Usual geriatric dose
See Cephalexin Capsules USP .

Strength(s) usually available
U.S.—


125 mg per 5 mL (when reconstituted according to manufacturer's instructions) (may be available in 100- and 200-mL bottles) (Rx) [Keflex ( sucrose)]{27}[Generic](may contain sucrose)


250 mg per 5 mL (when reconstituted according to manufacturer's instructions) (may be available in 100- and 200-mL bottles) (Rx) [Keflex ( sucrose)]{27}[Generic](may contain sucrose)

Canada—


125 mg per 5 mL (when reconstituted according to manufacturer's instructions) (may be available in 100-, 150-, and 200-mL bottles) (Rx) [Keflex (sodium)]{59} [Novo-Lexin ( sodium)]{76} [PMS-Cephalexin ( sodium)]{78}


250 mg per 5 mL (when reconstituted according to manufacturer's instructions) (may be available in 100-, 150-, and 200-mL bottles) (Rx) [Keflex (sodium)]{59} [Novo-Lexin ( sodium)]{76} [PMS-Cephalexin ( sodium)]{78}

Packaging and storage:
Prior to reconstitution, store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Preparation of dosage form:
See manufacturer's labeling for instructions.

Stability:
After reconstitution, suspensions retain their potency for 14 days if refrigerated {27}.

Auxiliary labeling:
   • Refrigerate.
   • Shake well.
   • Continue medicine for full time of treatment.
   • Beyond-use date.

Note: When dispensing, include a calibrated liquid-measuring device.



CEPHALEXIN TABLETS USP

Usual adult and adolescent dose
See Cephalexin Capsules USP .

Usual adult prescribing limits
See Cephalexin Capsules USP .

Usual pediatric dose
This dosage form usually is not used for children. See Cephalexin for Oral Suspension USP .

Usual geriatric dose
See Cephalexin Capsules USP .

Strength(s) usually available
U.S.—


250 mg (Rx)[Generic] (may be scored)


500 mg (Rx)[Generic] (may be scored)

Canada—


250 mg (Rx) [Apo-Cephalex (scored)]{77} [Keflex]{59} [Novo-Lexin]{76} [Nu-Cephalex]{61} [PMS-Cephalexin]{78}


500 mg (Rx) [Apo-Cephalex (scored)]{77} [Keflex]{59} [Novo-Lexin]{76} [Nu-Cephalex]{61} [PMS-Cephalexin]{78}

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Continue medicine for full time of treatment.


CEPHALEXIN HYDROCHLORIDE TABLETS USP

Usual adult dose
See Cephalexin Capsules USP .

Usual adult prescribing limits
See Cephalexin Capsules USP .

Usual pediatric dose
Safety and efficacy have not been established {28}.

Usual geriatric dose
See Cephalexin Capsules USP .

Strength(s) usually available
U.S.—


500 mg (Rx) [Keftab (sucrose)]{28}

Canada—
Not commercially available.

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Continue medicine for full time of treatment.


CEPHALOTHIN

Summary of Differences
Category: First-generation cephalosporin.

Precautions:

• Drug interactions and/or related problems—May be more likely to interact with nephrotoxic medications.


• Laboratory value alterations—May falsely elevate serum and urine creatinine concentrations when Jaffe's reaction method is used.



Additional Dosing Information
Since pain, induration, tenderness, and elevated temperature may occur on intramuscular administration, cephalothin should be administered by deep intramuscular injection or by intravenous injection.

When intravenous doses greater than 6 grams daily are given for more than 3 days, thrombophlebitis may occur. To help minimize the incidence of thrombophlebitis, larger veins may be used.


Parenteral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

The dosing and strengths of the dosage forms available are expressed in terms of cephalothin base (not the sodium salt).

CEPHALOTHIN FOR INJECTION USP

Usual adult and adolescent dose
[Furunculosis, with cellulitis ]or
[Pneumonia, uncomplicated] or
[Urinary tract infections]
Intramuscular or intravenous, 500 mg (base) every six hours {60}.

[Perioperative prophylaxis ]
Intravenous, 2 grams (base) one-half to one hour prior to the start of surgery; 2 grams during surgery; and 2 grams every six hours following surgery for up to forty-eight hours {60}.

[For all other infections ]
Intramuscular or intravenous, 500 mg to 2 grams (base) every four to six hours {60}.


Note: After an initial loading dose of 1 to 2 grams (base), adults with renal function impairment may require a reduction in dose as follows {60}:

Creatinine clearance (mL/min)/(mL/sec)   Dose (base) 
> 80/1.33  See Usual adult and adolescent dose
50–80/0.83–1.33   Up to 2 grams every 6 hours 
25–50/0.42–0.83  Up to 1.5 grams every 6 hours 
10–25/0.17–0.42  Up to 1 gram every 6 hours 
2–10/0.03–0.17  Up to 500 mg every 6 hours 
<2/0.03  Up to 500 mg every 8 hours  



Usual adult prescribing limits
12 grams (base) per day {60}.

Usual pediatric dose
[For bacterial infections ]
Intramuscular or intravenous, 13.3 to 26.6 mg (base) per kg of body weight every four hours; or 20 to 40 mg per kg of body weight every six hours {60}.


Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—
Not commercially available.

Canada—


1 gram (base) (may be available in ADD-Vantage® vials) (Rx) [Ceporacin]{79} [Keflin (sodium 2.8 mEq per gram)]{60}

Packaging and storage:
Prior to reconstitution, store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Preparation of dosage form:
To prepare initial dilution for intramuscular use, 4.5 mL of sterile water for injection should be added to each 1-gram vial. {60}

To prepare initial dilution for intravenous use, 10 mL of sterile water for injection, 5% dextrose injection, or 0.9% sodium chloride injection should be added to each 1-gram vial. For direct or intermittent use, the resulting solution should be administered over a 3- to 5-minute period. For continuous infusion, the resulting solution should be further diluted in suitable fluids (see manufacturer's package insert). {60}

Stability:
After reconstitution, solutions retain their potency for 8 hours at room temperature or for 72 hours if refrigerated. Solutions reconstituted with bacteriostatic diluent and used for intramuscular administration retain their potency for up to 7 days when refrigerated. {60}

Concentrated solutions will darken in color, especially at room temperature. However, slight discoloration does not affect potency. {60}

Incompatibilities:
The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle.


CEPHAPIRIN

Summary of Differences
Category: First-generation cephalosporin.


Additional Dosing Information
Cephapirin should be administered by deep intramuscular injection or by intravenous injection only.


Parenteral Dosage Forms

Note: The dosing and strengths of the dosage forms available are expressed in terms of cephapirin base (not the sodium salt).

CEPHAPIRIN FOR INJECTION USP

Usual adult and adolescent dose
Perioperative prophylaxis 1
Intramuscular or intravenous, 1 to 2 grams (base) one-half to one hour prior to the start of surgery; 1 to 2 grams during surgery; and 1 to 2 grams every six hours following surgery for up to twenty-four hours {29}.

Skin and soft tissue infections 1 or
Urinary tract infections1
Intramuscular or intravenous, 500 mg (base) every four to six hours {29}.

For all other infections 1
Serious: Intramuscular or intravenous, 1 gram (base) every four to six hours {29}.

Very serious or life-threatening: Intravenous, up to 12 grams (base) per day {29}.


Note: Patients with impaired renal function (moderately severe oliguria or serum creatinine above 5 mg per 100 mL) may receive 7.5 to 15 mg (base) per kg of body weight every twelve hours {29}.
Patients with severely reduced renal function and who are to be dialyzed should receive 7.5 to 15 mg (base) per kg of body weight just prior to dialysis and every twelve hours thereafter {29}.


Usual adult prescribing limits
12 grams (base) per day {29}.

Usual pediatric dose
For bacterial infections 1
Infants up to 3 months of age: Dosage has not been established {29}.
Infants and children 3 months of age and older: Intramuscular or intravenous, 10 to 20 mg (base) per kg of body weight every six hours {29}.


Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


500 mg (base) (Rx) [Cefadyl (sodium 2.36 mEq per gram)]{29}


1 gram (base) (Rx) [Cefadyl (sodium 2.36 mEq per gram)]{29}


2 grams (base) (Rx) [Cefadyl (sodium 2.36 mEq per gram)]{29}


4 grams (base) (Rx) [Cefadyl (sodium 2.36 mEq per gram)]{29}


20 grams (base) (Rx) [Cefadyl (sodium 2.36 mEq per gram)]{29}

Canada—
Not commercially available.

Packaging and storage:
Prior to reconstitution, store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Preparation of dosage form:
To prepare initial dilution for intramuscular use, 1 mL of sterile water for injection or bacteriostatic water for injection should be added to each 500-mg vial, or 2 mL of diluent should be added to each 1-gram vial. {29}

To prepare initial dilution for intravenous use, 10 mL or more of bacteriostatic water for injection, dextrose injection, or 0.9% sodium chloride injection should be added to each 500-mg, 1-gram, or 2-gram vial. For direct injection, the resulting solution should be administered slowly over a 3- to 5-minute period. For intermittent infusion, the resulting solution should be diluted with suitable fluids (see manufacturer's package insert). {29}

For reconstitution of pharmacy bulk vials or piggyback infusion bottles, see manufacturer's labeling for instructions.

Stability:
After reconstitution, solutions retain their potency for 12 to 48 hours at room temperature (25 °C [77 °F]), depending on the diluent, or for 10 days if refrigerated at 4 °C (39 °F). Color changes during the indicated storage times do not affect potency. {29}

If frozen immediately after reconstitution with sterile water for injection, bacteriostatic water for injection containing either benzyl alcohol or parabens, 0.9% sodium chloride injection, or 5% dextrose injection, solutions retain their potency for up to 60 days at –15 °C (5 °F). After thawing at room temperature, solutions retain their potency for at least 12 hours at room temperature or for 10 days if refrigerated at 4 °C (39 °F). {29}

At concentrations of 2 to 30 mg per mL in suitable fluids (see manufacturer's package insert), intravenous infusions retain their potency for 24 hours at room temperature. At a concentration of 4 mg per mL in suitable fluids (see manufacturer's package insert), intravenous infusions retain their potency for 10 days if refrigerated or for 14 days if frozen at –15 °C (5 °F). After thawing at room temperature, these infusions retain their potency for 24 hours at room temperature. {29}

Incompatibilities:
The admixture of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle.


CEPHRADINE

Summary of Differences
Category: First-generation cephalosporin.


Additional Dosing Information
May be taken with or without food.


Oral Dosage Forms

CEPHRADINE CAPSULES USP

Usual adult and adolescent dose
Pneumonia, lobar1 or
Prostatitis1or
Urinary tract infections, serious1
Oral, 500 mg every six hours; or 1 gram every twelve hours {30}.

Respiratory tract infections, other than lobar pneumonia1 or
Skin and soft tissue infections1
Oral, 250 mg every six hours; or 500 mg every twelve hours {30}.

Urinary tract infections, uncomplicated1
Oral, 500 mg every twelve hours {30}.

For all other infections, severe or chronic1
Oral, up to 1 gram every six hours {30}.


Note: Adults with impaired renal function may require a reduction in dose as follows {30}:

Creatinine clearance
(mL/min)/(mL/sec) 
Dose 
> 20/0.33  500 mg every 6 hours  
5–20/0.08–0.33   250 mg every 6 hours 
< 5/0.08  250 mg every 12 hours  
Chronic intermittent
hemodialysis patients 
250 mg at the start of hemodialysis; 250 mg after 12 hours; and 250 mg 36–48 hours after start 



Usual adult prescribing limits
4 grams per day {30}.

Usual pediatric dose
This dosage form usually is not used for children. See Cephradine for Oral Suspension USP .

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


250 mg (Rx) [Velosef (lactose)]{30}[Generic]


500 mg (Rx) [Velosef (lactose)]{30}[Generic]

Canada—
Not commercially available.

Packaging and storage:
Store below 30 °C (86 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Continue medicine for full time of treatment.


CEPHRADINE FOR ORAL SUSPENSION USP

Usual adult and adolescent dose
See Cephradine Capsules USP .

Usual adult prescribing limits
See Cephradine Capsules USP .

Usual pediatric dose
Otitis media, due to Haemophilus influenzae1
Infants and children 9 months of age and older: Oral, 18.75 to 25 mg per kg of body weight every six hours; or 37.5 to 50 mg per kg of body weight every twelve hours {30}.

Infants up to 9 months of age: Oral, 18.75 to 25 mg per kg of body weight every six hours {30} {157}.

For all other infections 1
Infants and children 9 months of age and older:


Mild or moderate—Oral, 6.25 to 12.5 mg per kg of body weight every six hours; or 12.5 to 25 mg per kg of body weight every twelve hours {30}.


Severe or chronic—Oral, up to 1 gram every six hours {30}.

Infants up to 9 months of age:


Mild or moderate—Oral, 6.25 to 12.5 mg per kg of body weight every six hours {30} {157}.


Severe—Oral, up to 1 gram every six hours {30} {157}.


Note: Pediatric patients with renal function impairment may require a reduction in dose proportional to their weight and severity of infection {30}.


Usual pediatric prescribing limits
4 grams per day {30}.

Usual geriatric dose
See Cephradine Capsules USP .

Strength(s) usually available
U.S.—


125 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 100- and 200-mL bottles) (Rx) [Velosef (sucrose )]{30}[Generic] ( may contain sucrose)


250 mg per 5 mL (when reconstituted according to manufacturer's instructions) (available in 100- and 200-mL bottles) (Rx) [Velosef (sucrose )]{30}[Generic] ( may contain sucrose)

Canada—
Not commercially available.

Packaging and storage:
Prior to reconstitution, store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Preparation of dosage form:
See manufacturer's labeling instructions.

Stability:
After reconstitution, suspensions retain their potency for 7 days at room temperature or for 14 days if refrigerated {30}.

Auxiliary labeling:
   • Refrigerate.
   • Shake well.
   • Continue medicine for full time of treatment.
   • Beyond-use date.

Note: When dispensing, include a calibrated liquid-measuring device.




Revised: 02/26/2003



References
  1. Cefaclor package insert (Ceclor, Eli Lilly—US), Rev 12/96, Rec 9/97; Rev 1/98, Rec 7/98.
  1. Cefaclor package insert (Ceclor CD, Dura—US), New 8/96, Rec 9/96.
  1. Cefadroxil package insert (Duricef, Bristol-Meyers Squibb—US), Rev 10/94, Rec 8/97; Rev 2/97, Rec 6/98.
  1. Cefamandole package insert (Mandol, Eli Lilly—US), New 3/96, Rec 8/97.
  1. Cefazolin package insert (Ancef, SmithKline Beecham—US), Rev 11/97, Rec 2/98.
  1. Cefazolin package insert (Kefzol, Eli Lilly—US), Rev 8/94, Rec 8/97; Rev 11/97, Rec 7/98.
  1. Cefepime package insert (Maxipime, Bristol-Meyers Squibb—US), Rev 5/97, Rec 8/97; Rev 1/98, Rec 6/98.
  1. Cefixime package insert (Suprax, Lederle—US), Rev 7/96, Rec 8/97.
  1. Cefonicid package insert (Monocid, SmithKline Beecham—US), New 8/94, Rec 8/97.
  1. Cefoperazone package insert (Cefobid, Pfizer—US), Rev 2/97, Rec 8/97.
  1. Cefotaxime package insert (Claforan, Hoechst-Roussel—US), Rev 10/96, Rec 5/97.
  1. Cefotetan package insert (Cefotan, Zeneca—US), Rev 2/97, Rec 8/97.
  1. Cefoxitin package insert (Mefoxin, Merck—US), Rev 8/96, Rec 8/97.
  1. Cefpodoxime package insert (Vantin, Pharmacia & Upjohn—US), Rev 3/97, Rec 8/97.
  1. Cefprozil package insert (Cefzil, Bristol-Meyers Squibb—US), Rev 5/97, Rec 8/97.
  1. Ceftazidime package insert (Ceptaz, Glaxo Wellcome—US), Rev 9/96, Rec 8/97; Rev 2/98, Rec 4/98.
  1. Ceftazidime package insert (Fortaz, Glaxo Wellcome—US), Rev 3/96, Rec 8/97; Rev 2/98, Rec 4/98.
  1. Ceftazidime package insert (Tazicef, SmithKline Beecham—US), Rev 7/97, Rec 2/98.
  1. Ceftazidime package insert (Tazidime, Eli Lilly—US), Rev 4/96, Rec 8/97.
  1. Ceftibuten package insert (Cedax, Schering—US), Rev 11/96, Rec 8/97.
  1. Ceftizoxime (for intravenous use only) package insert (Cefizox, Fujisawa—US), Rev 4/97, Rec 1/98.
  1. Ceftizoxime (for intramuscular or intravenous use) package insert (Cefizox, Fujisawa—US), Rev 4/97, Rec 8/97.
  1. Ceftriaxone package insert (Rocephin, Roche—US), Rev 1/96, Rec 8/97; Rev 1/98, Rec 6/98.
  1. Cefuroxime axetil package insert (Ceftin, Glaxo Wellcome—US), Rev 10/97, Rec 11/97; Rev 4/98, Rec 6/98.
  1. Cefuroxime package insert (Kefurox, Eli Lilly—US), Rev 8/95, Rec 8/97; Rev 8/96, Rec 2/98.
  1. Cefuroxime package insert (Zinacef, Glaxo Wellcome—US), Rev 1/97, Rec 8/97; Rev 4/98, Rec 6/98.
  1. Cephalexin package insert (Keflex, Dista—US), Rev 9/96, Rec 8/97.
  1. Cephalexin hydrochloride package insert (Keftab, Dura—US), New 9/96, Rec 8/97; Rev 10/97, Rec 2/98.
  1. Cephapirin package insert (Cefadyl, Apothecon—US), Rev 6/92, Rec 8/97.
  1. Cephradine package insert (Velosef, Apothecon—US), Rev 7/91, Rec 8/97.
  1. Dajani AS, Taubert KA, Wilson W, et al. Prevention of bacterial endocarditis. JAMA 1997; 277: 1794-801.
  1. References for Table 1: Cefaclor 1, 2, 40, 54; Cefadroxil 3, 138; Cefamandole 4, 55, 132; Cefazolin 5, 6, 56, 132; Cefdinir 160; Cefepime 7, 85; Cefixime 8, 181; Cefonicid 9, 132; Cefoperazone 10, 132; Cefotaxime 11, 87, 132; Cefotetan 12; Cefoxitin 13, 68, 132, 134; Cefpodoxime 14; Cefprozil 15, 36, 37, 38; Ceftazidime 16–19, 42; Ceftibuten 20, 52, 53, 88; Ceftizoxime 21, 22, 132; Ceftriaxone 23, 132; Cefuroxime 24–26, 44, 46, 132; Cephalexin 27, 61, 132; Cephalothin 60, 132; Cephapirin 29; Cephradine 30, 132.
  1. References for Table 2: Cefaclor 1, 2, 40, 54, 132; Cefadroxil 3, 62, 132; Cefamandole 4, 55; Cefazolin 5, 6, 56, 132; Cefdinir 160; Cefepime 7, 64, 80, 83–86; Cefixime 8, 181; Cefonicid 9, 132; Cefoperazone 10, 132; Cefotaxime 11, 42, 66, 132; Cefotetan 12, 49, 50; Cefoxitin 13, 68, 132; Cefpodoxime 14, 135, 136; Cefprozil 15, 36, 37, 39, 69; Ceftazidime 16–19, 42, 71; Ceftibuten 20, 52, 53; Ceftizoxime 21, 22, 132; Ceftriaxone 23, 41, 42, 132; Cefuroxime 24–26, 46, 75, 132; Cephalexin 27, 132; Cephalothin 60, 132; Cephapirin 29; Cephradine 30, 132.
  1. Canada JR, editor. USP dictionary of USAN and international drug names 1998. Rockville, MD: The United States Pharmacopeial Convention Inc; 1997. Cefaclor: p. 138; Cefadroxil, Cefamandole nafate: p. 139; Cefazolin sodium: p. 140; Cefepime, Cefepime hydrochloride, Cefixime: p. 141; Cefonicid sodium: p. 142; Cefoperazone sodium, Cefotaxime sodium, Cefotetan disodium: p. 143; Cefoxitin sodium, Cefpodoxime proxetil: p. 144; Cefprozil, Ceftazidime: p. 145; Ceftibuten, Ceftizoxime sodium, Ceftriaxone sodium: p. 146; Cefuroxime axetil, Cefuroxime sodium: p. 147; Cephalexin: p. 148; Cephalothin sodium, Cephapirin sodium, Cephradine: p. 149.
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  1. Leitner F, Pursiano TA, Buck RE, et al. BMY 28100, a new oral cephalosporin. Antimicr Agents Chemother 1987; 31(2): 238-43.
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  1. Schaad UB, Suter S, Gianella-Borradori A, et al. A comparison of ceftriaxone and cefuroxime for the treatment of bacterial meningitis in children. N Engl J Med 1990; 322(3): 141-7.
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  1. Carver PL, Nightingale CH, Quintiliani R. Pharmacokinetics and pharmacodynamics of total and unbound cefoxitin and cefotetan in healthy volunteers. J Antimicr Chemother 1989; 23: 99-106.
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  1. Cefaclor (Ceclor, Eli Lilly). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 278-80.
  1. Cefamandole (Mandol, Eli Lilly). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 935-7..
  1. Cefazolin (Kefzol, Eli Lilly). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 835-7.
  1. Ceftazidime (Tazidime, Eli Lilly). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 1637-9.
  1. Cefuroxime (Kefurox, Eli Lilly). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 834-5.
  1. Cephalexin (Keflex, Eli Lilly). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 832-3.
  1. Cephalothin (Keflin, Eli Lilly). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 833-4.
  1. Cephalexin product monograph (Nu-Cephalex, Nu-Pharm—Canada), Rev 9/89, Rec 9/97.
  1. Cefadroxil (Duricef, Bristol). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 539-40.
  1. Cefazolin (Ancef, SmithKline Beecham). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 83-4.
  1. Cefepime (Maxipime, Bristol-Meyers Squibb). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 950-1.
  1. Cefixime (Suprax, Rhone-Poulenc Rorer). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 1597-8.
  1. Cefotaxime (Claforan, Hoechst Marion Roussel). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 324-6.
  1. Cefotetan (Cefotan, Wyeth-Ayerst). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 284-6.
  1. Cefoxitin (Mefoxin, MSD). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 958-60.
  1. Cefprozil (Cefzil, Bristol-Meyers Squibb). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 288-90.
  1. Ceftazidime (Ceptaz, Glaxo Wellcome). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 298-300.
  1. Ceftazidime (Fortaz, Glaxo Wellcome). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 644-6.
  1. Ceftizoxime (Cefizox, SmithKline Beecham). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 283-4.
  1. Ceftriaxone (Rocephin, Roche). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 1477-9.
  1. Cefuroxime axetil (Ceftin, Glaxo Wellcome). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 287-8.
  1. Cefuroxime sodium (Zinacef, Glaxo Wellcome). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 1894-6.
  1. Cephalexin (Novo-Lexin, Novopharm). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 1171.
  1. Cephalexin (Apo-Cephalex, Apotex). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 99.
  1. Cephalexin (PMS-Cephalexin, Pharmascience). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 1323.
  1. Cephalothin (Ceporacin, Bioniche).

    In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ontario, Canada: Canadian Pharmaceutical Association; 1998. p. 298.
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  1. Barbhaiya RH, Forgue ST, Gleason CR, et al. Pharmacokinetics of cefepime after single and multiple intravenous administrations in healthy subjects. Antimicrob Agents Chemother 1992; 36(3): 552-7.
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  1. Barr WH, Lin CC, Radwanski E, et al. The pharmacokinetics of ceftibuten in humans. Diagn Microbiol Infect Dis 1991; 14: 93-100.
  1. Panel comments, 8/88.
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  1. Panel comment, 4/30/90.
  1. Panel comment, 7/90.
  1. Panel comment, 8/27/89.
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  1. Panel comment, 9/9/85.
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  1. Panel comment, 12/93.
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  1. Drug evaluations. Chicago: American Medical Association, September 1995: 1413-80.
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  1. Vancocin package insert (Eli Lilly—US), Rev 6/96, Rec 9/97.
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  1. Panel comment, 8/3/89.
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  1. Panel comment, 4/98.
  1. Panel comment, 4/98.
  1. Panel comment, 4/98.
  1. Manufacturer comment, 4/98.
  1. Panel comment, 4/98.
  1. Panel comment, 4/98.
  1. Manufacturer comment, 4/98.
  1. Manufacturer comment, 4/98.
  1. Panel comment, 4/98.
  1. Manufacturer comment, 4/98.
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  1. Reviewers' consensus on monograph revision of 6/98.
  1. Reviewers' consensus on monograph revision of 6/98.
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  1. Product Information: Omnicef, cefdinir. Parke-Davis, Morris Plains, NJ, USA, Rev. 7/99.
  1. Product Information Maxipime, cefepime. Dura Pharmaceuticals, San Diego, CA, USA, (PI revised 5/99), reviewed 4/2000.
  1. Product Information Mandol, cefamandole. Eli Lilly, Indianapolis, IN, USA, (PI revised 10/96), reviewed 6/2000.
  1. Panel consensus, 1/2000.
  1. Simpson AJH, Suputtamongkol Y, Smith MD, et al. Comparison of imipenem and ceftazidime as therapy for severe melioidosis. Clin Infect Dis 1999; 29: 381-7.
  1. Sookpranee M, Boonma P, Susaengrat W, et al. Multicenter prospective randomized trial comparing ceftazidime plus co-trimoxazole with chloramphenicol plus doxycycline and co-trimoxazole for treatment of severe melioidosis. Antimicrob Agents Chemother 1992; 36(1): 158-62.
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  1. Thamprajamchit S, Chetchotisakd P, Thinkhamrop B. Cefoperazone/sulbactam + co-trimoxazole vs ceftazidime + co-trimoxazole in the treatment of severe melioidosis: a randomized double-blind controlled study. J Med Assoc Thai 1998; 265-71.
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  1. Smith MD, Suputtamongkol Y, Chaowagul W, et al. Elevated serum procalcitonin levels in patients with melioidosis. Clin Infect Dis 1995; 20: 641-5.
  1. Walsh AL, Smith MD, Wuthiekanun V, et al. Prognostic significance of quantitative bacteremia in septicemic melioidosis. Clin Infect Dis 1995; 21: 1498-500.
  1. Carmeli Y, Samore MH. Comparison of treatment with imipenem vs ceftazidime as a predisposing factor for nosocomial acquisition of Stenotrophomonas maltophilia: a historical cohort study. Clin Infect Dis 1997; 24(6): 1131-4.
  1. Tiangpitayakorn C, Sirirurg S, Piyasangthong N, et al. Speed of detection of Burkholderia pseudomallei in blood cultures and its correlation with the clinical outcome. Am J Trop Med Hyg 1997; 24(6): 96-9.
  1. Product Information: Rocephin®, ceftriaxone sodium. Hoffmann-LaRoche, New Jersey (PI revised 9/2000) PI reviewed 3/2001
  1. Product Information: Ceftin®, cefuroxime axetil. Glaxo Wellcome, Triangle Park, North Carolina (PI revised 08/2000) PI reviewed 05/2001
  1. Product Information: Spectracef™, cefditoren. TAP Pharmaceuticals, Lake Forest, Illinois (PI revised 08/2001) PI reviewed 11/2001
  1. Expert committee comment, 01/2001.
  1. Product Information: Zinacef®, cefuroxime. GlaxoSmithKline Inc., Mississauga, Ontario, Canada, (PI revised 05/01/2002) reviewed 10/2002.
  1. Product Information: Zinacef®,cefuroxime.GlaxoSmithKline Inc., Research Triangle Park, NC, (PI revised 10/2001) reviewed 10/2002
  1. CDC: Notice to Readers: Discontinuation of cefixime tablets-United States. MMWR 2002; 51: 1052
  1. Product Information: Ceftin®, cefuroxime. GlaxoSmithKline Inc., Research Triangle Park, NC, (PI revised 11/2002) reviewed 12/2002
  1. Product Information: Suprax, cefixime. Aventis, Laval, Quebec (PI revised 12/2000) reviewed 01/2003
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