Class: Third Generation Cephalosporins
Chemical Name: [6R - [6α,7β(Z)]] - 7 - [[(2 - Amino - 4 - thiazoyl)[(carboxymethoxy)imino]acetyl]amino] - 3 - ethenyl - 8 - oxo - 5 - thia - 1 - azabicyclo[4.2.0]oct - 2 - ene - 2 - carboxylic acid
CAS Number: 79350-37-1
Uses for Cefixime
Acute Otitis Media (AOM)
Treatment of AOM1 2 3 5 23 43 56 61 62 63 75 138 164 165 caused by Haemophilus influenzae,1 2 23 61 62 63 Moraxella catarrhalis,1 2 23 61 62 63 or Streptococcus pyogenes (group A β-hemolytic streptococci).1 2 23 62 63
When anti-infectives indicated, AAP recommends high-dose amoxicillin or amoxicillin and clavulanate as drugs of choice for initial treatment of AOM; certain cephalosporins (cefdinir, cefpodoxime, cefuroxime, ceftriaxone) recommended as alternatives for initial treatment in penicillin-allergic patients without a history of severe and/or recent penicillin-allergic reactions.184
Pharyngitis and Tonsillitis
Treatment of pharyngitis and tonsillitis caused by susceptible S. pyogenes (group A β-hemolytic streptococci).1 2 3 5 23 44 56 64 75 Generally effective in eradicating S. pyogenes from nasopharynx; efficacy in prevention of subsequent rheumatic fever not established to date.1
AAP, IDSA, AHA, and others recommend a penicillin regimen (10 days of oral penicillin V or oral amoxicillin or single dose of IM penicillin G benzathine) as treatment of choice for S. pyogenes pharyngitis and tonsillitis;82 86 104 152 other anti-infectives (oral cephalosporins, oral macrolides, oral clindamycin) recommended as alternatives in penicillin-allergic patients.82 86 104 152
If an oral cephalosporin used, 10-day regimen of first generation cephalosporin (cefadroxil, cephalexin) preferred instead of other cephalosporins with broader spectrums of activity (e.g., cefaclor, cefdinir, cefixime, cefpodoxime, cefuroxime).82 86 152
Respiratory Tract Infections
Treatment of mild to moderate community-acquired pneumonia† (CAP) caused by S. pneumoniae,2 23 44 70 72 103 H. influenzae,1 2 23 44 70 72 103 M. catarrhalis,2 44 70 72 103 137 166 Escherichia coli, H. parahaemolyticus, or H. parainfluenzae.2 3 44 64 75
Treatment of mild to moderate sinusitis† caused by S. pneumoniae,2 23 44 70 72 103 H. influenzae,1 2 23 44 70 72 103 M. catarrhalis,2 44 70 72 103 137 166 E. coli, H. parahaemolyticus, or H. parainfluenzae.2 3 44 75 Because of variable activity against S. pneumoniae and H. influenzae, IDSA no longer recommends second or third generation oral cephalosporins for empiric monotherapy of acute bacterial sinusitis.192 Oral amoxicillin or amoxicillin and clavulanate usually recommended for empiric treatment.192 193 If an oral cephalosporin used as an alternative in children (e.g., in penicillin-allergic individuals), combination regimen that includes a third generation cephalosporin (cefixime or cefpodoxime) and clindamycin (or linezolid) recommended.192 193
Urinary Tract Infections (UTIs)
Treatment of uncomplicated UTIs1 2 5 40 51 64 74 75 182 caused by susceptible E. coli1 2 40 51 64 74 75 182 or Proteus mirabilis;1 2 40 51 74 75 182 also has been used for treatment of uncomplicated UTIs caused by susceptible Citrobacter spp.†,2 51 64 74 C. diversus†,2 74 C. freundii†,2 74 Enterobacter spp.†,2 40 51 E. aerogenes†,2 40 74 E. agglomerans†,2 64 Klebsiella spp.†,2 40 51 182 K. pneumoniae†,2 64 74 Morganella morganii†,2 Proteus spp.†,2 51 64 or Serratia†.2 51 74
Has been used for treatment of uncomplicated UTIs1 2 5 40 51 64 74 75 182 caused by susceptible gram-positive bacteria, including Staphylococcus epidermidis†,2 Staphylococcus spp.†,2 51 Streptococcus agalactiae†,2 40 nonhemolytic streptococci†,2 40 51 or Enterococcus faecalis†.2 40 Consider that treatment failures have been reported and gram-positive bacteria (e.g., staphylococci, S. agalactiae, enterococci) have been isolated in urine during or after cefixime treatment and usually are resistant to cefixime.2 51 74
Gonorrhea and Associated Infections
Because of concerns related to recent reports of N. gonorrhoeae with reduced susceptibility to cephalosporins, CDC states that oral cephalosporins no longer recommended as first-line treatment for uncomplicated gonorrhea.197 For treatment of uncomplicated urogenital, anorectal, or pharyngeal gonorrhea, CDC recommends a combination regimen that includes a single dose of IM ceftriaxone and either a single dose of oral azithromycin or 7-day regimen of oral doxycycline.197
Cefixime recommended by CDC as an alternative in patients with urogenital or rectal† gonorrhea when ceftriaxone cannot be used or not available;197 used in conjunction with single dose of oral azithromycin or 7-day regimen of oral doxycycline.197
Consider that N. gonorrhoeae with reduced susceptibility to cefixime, including some treatment failures, reported in US and other countries.194 195 196 197 198 Perform test-of-cure follow-up (culture or nucleic acid amplification test [NAAT]) 1 week after cefixime treatment.197
If infection persists (treatment failure), culture relevant clinical specimens and perform in vitro susceptibility tests.197 Also consult infectious disease specialist, STD/HIV Prevention Training Center (), or CDC (404-639-8659) for treatment advice and report the case to CDC through local or state health departments within 24 hours of diagnosis.197
For all gonorrhea patients, ensure that their sex partners from preceding 60 days are evaluated promptly with culture and treated with a recommended regimen if indicated.197
Has been used for treatment of disseminated Lyme disease†.181 Other cephalosporins (cefotaxime, ceftriaxone, cefuroxime axetil) usually recommended by IDSA and others when a cephalosporin is used in the treatment of Lyme disease.104 185
Salmonella and Shigella Infections
Cefixime Dosage and Administration
Administer orally as capsules, conventional tablets, chewable tablets, or oral suspension.1
Capsules and conventional tablets: Administer without regard to meals.1 (See Food under Pharmacokinetics.)
Chewable tablets: Must be chewed or crushed before swallowing.1
Reconstitute oral suspension at the time of dispensing by adding amount of water specified on the container in 2 equal portions; shake after each addition.1 The reconstituted suspension contains 100, 200, or 500 mg/5 mL.1
Shake oral suspension well just prior to administration of each dose.1
Available as cefixime trihydrate; dosage expressed in terms of cefixime.1
Capsules containing 400 mg of cefixime are bioequivalent to conventional 400-mg tablets when administered under fasting conditions.1
Chewable tablets are bioequivalent to oral suspension.1
Conventional tablets and oral suspension are not bioequivalent1 (see Absorption under Pharmacokinetics).
General Pediatric Dosage
Children beyond neonatal period: AAP recommends 8 mg/kg daily in 1 or 2 equally divided doses for treatment of mild or moderate infections.82 AAP states the drug is inappropriate for treatment of severe infections.82
Children weighing 5–7.5 kg: Oral suspension containing 100 mg/5 mL is preferred preparation.1
Children weighing 7.6–10 kg: Oral suspension containing 100 or 200 mg/5 mL is preferred preparation.1
Children weighing <10 kg: Chewable tablets not recommended.1
Acute Otitis Media (AOM)
Do not use capsules or conventional tablets for treatment of AOM.1
Pharyngitis and Tonsillitis
Children 6 months to 12 years of age: 8 mg/kg once daily or 4 mg/kg every 12 hours for ≥10 days.1
Respiratory Tract Infections
Acute Exacerbations of Chronic BronchitisOral
Empiric Treatment of Acute Bacterial Sinusitis†Oral
8 mg/kg daily in 2 equally divided doses for 10–14 days.192
Urinary Tract Infections (UTIs)
Gonorrhea and Associated Infections
Uncomplicated Urethral, Endocervical, or Rectal† GonorrheaOral
Prepubertal children weighing <45 kg: 8 mg/kg (up to 400 mg) as a single dose.82
Children ≥8 years of age or weighing ≥45 kg: 400 mg as a single dose.82
Use in conjunction with single dose of oral azithromycin or 7-day regimen of oral doxycycline.82 197 Not recommended by CDC as first-line treatment.197 (See Gonorrhea and Associated Infections under Uses.)
Salmonella and Shigella Infections†
Acute Otitis Media (AOM)
Do not use capsules or conventional tablets for treatment of AOM.1
Pharyngitis and Tonsillitis
400 mg once daily or 200 mg every 12 hours for ≥10 days.1
Respiratory Tract Infections
Acute Exacerbations of Chronic BronchitisOral
Urinary Tract Infections (UTIs)
Gonorrhea and Associated Infections
Uncomplicated Urethral, Endocervical, or Rectal† GonorrheaOral
Use in conjunction with oral azithromycin (single 1-g dose) or oral doxycycline (100 mg twice daily for 7 days).197 Not recommended by CDC as first-line treatment.197 (See Gonorrhea and Associated Infections under Uses.)
200 mg daily for 100 days (administered with oral probenecid).181
Dosage adjustments necessary in patients with Clcr <60 mL/minute.1 2 Adults with Clcr 21–59 mL/minute: 260 mg daily as oral suspension, preferably as oral suspension containing 200 or 500 mg/5 mL; conventional tablets and chewable tablets not recommended.1
Adults with Clcr ≤20 mL/minute: 200 mg daily as conventional tablets or chewable tablets, 172 mg daily as oral suspension containing 100 mg/5 mL, 176 mg daily as oral suspension containing 200 mg/5 mL, or 180 mg daily as oral suspension containing 500 mg/5 mL.1
Adults undergoing hemodialysis: 260 mg daily as oral suspension, preferably as oral suspension containing 200 or 500 mg/5 mL; conventional tablets and chewable tablets not recommended.1
Adults undergoing continuous peritoneal dialysis: 200 mg daily as conventional tablets or chewable tablets, 172 mg daily as oral suspension containing 100 mg/5 mL, 176 mg daily as oral suspension containing 200 mg/5 mL, or 180 mg daily as oral suspension containing 500 mg/5 mL.1
Cautions for Cefixime
Known hypersensitivity to cefixime or other cephalosporins.1
Superinfection/Clostridium difficile-associated Diarrhea and Colitis
Possible emergence and overgrowth of nonsusceptible bacteria or fungi, especially Enterobacter, Pseudomonas, enterococci, staphylococci, or Candida.1 5 Careful observation of the patient is essential.1 Institute appropriate therapy if superinfection occurs.1
Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.1 42 177 178 C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including cefixime, and may range in severity from mild diarrhea to fatal colitis.1 42 177 178 C. difficile produces toxins A and B which contribute to development of CDAD;1 40 42 hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.1
Consider CDAD if diarrhea develops during or after therapy and manage accordingly.1 42 177 178 Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.42
If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible.42 177 178 Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.1 42 177 178
Hypersensitivity reactions such as anaphylaxis (including shock and fatalities), angioedema, serum sickness-like reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.1 5 40 41 43 56 64 75
If an allergic reaction occurs, discontinue cefixime and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).1
Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.1 Cefixime is contraindicated in individuals hypersensitive to cephalosporins.1 Avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.173
Selection and Use of Anti-infectives
To reduce development of drug-resistant bacteria and maintain effectiveness of cefixime and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.1
When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1
Chewable tablets containing 100, 150, and 200 mg of cefixime contain aspartame (NutraSweet), which is metabolized in the GI tract to provide 3.3, 5, and 6.7 mg of phenylalanine, respectively.1
Coombs’ Test Results
Decreased Prothrombin Activity
Patients with renal or hepatic impairment, poor nutritional status, prolonged anti-infective therapy, and previous anticoagulant therapy (stabilized) appear to be at risk.1 Monitor PT in such patients and administer exogenous vitamin K as indicated.1
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1
Common Adverse Effects
GI effects (diarrhea,1 2 33 40 41 43 44 51 56 63 64 67 75 103 loose or frequent stools,1 abdominal pain,1 2 23 40 41 44 51 56 64 67 75 nausea,1 2 23 40 41 44 51 63 64 74 75 dyspepsia,1 2 23 40 41 44 51 75 flatulence).1 2 40 41 75
Interactions for Cefixime
Specific Drugs and Laboratory Tests
Drug or Test
Antacids (aluminum- or magnesium-containing)
No clinically important effect on cefixime pharmacokinetics 32
Anticoagulants, oral (warfarin)
Possible increased PT (with or without bleeding)1
Increased carbamazepine concentrations1
Monitor carbamazepine concentrations1
Possible increased plasma concentrations and AUC of cefixime143
Increased cefixime plasma concentrations and AUC2
Tests for glucose
Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution1
Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)1
Tests for ketones
Possible false-positive reaction for ketones in urine if nitroprusside tests used; not reported with tests using nitroferricyanide1
Capsules containing 400 mg of cefixime are bioequivalent to conventional tablets containing 400 mg of the drug when administered under fasting conditions.1
Chewable tablets are bioequivalent to the oral suspension.1
Conventional tablets and oral suspension are not bioequivalent;1 studies in adults indicate oral suspension results in peak serum concentrations 25–50% higher than concentrations attained with tablets.1
Capsules: Food decreases absorption by about 15% (based on AUC) or 25% (based on peak serum concentrations).1
Distribution into CSF unknown.1
Plasma Protein Binding
Adults with moderate renal impairment (Clcr 20–40 mL/minute): Serum half-life averages 6.4 hours.1
Adults with severe renal impairment (Clcr 5–20 mL/minute): Serum half-life averages 11.5 hours.1
Capsules, Conventional Tablets, Chewable Tablets
Actions and Spectrum
Based on spectrum of activity, classified as a third generation cephalosporin.3 13 15 50 69 75 Expanded spectrum of activity against gram-negative bacteria compared with first and second generation cephalosporins;2 3 5 14 23 59 60 75 less active against Enterobacteriaceae than some other third-generation cephalosporins.15 75 101
Gram-positive aerobes: Active in vitro against Streptococcus pneumoniae1 and Streptococcus pyogenes (group A β-hemolytic streptococci).1 2 3 13 14 20 23 50 59 60 66 77 78 79 Also active in vitro against S. agalactiae (group B streptococci)1 2 13 15 18 23 50 59 60 66 75 and groups C, F, and G streptococci.13 23 59 60 66 Most staphylococci, enterococci, and Listeria monocytogenes are resistant.1 2 3 13 14 18 20 23 59 60 66 69 75 78 101
Strains of staphylococci resistant to penicillinase-resistant penicillins (methicillin-resistant [oxacillin-resistant] staphylococci) should be considered resistant to cefixime, although results of in vitro susceptibility tests may indicate susceptibility.132
Gram-negative aerobes: Active in vitro against Neisseria gonorrhoeae,1 2 3 5 11 14 23 59 60 75 Haemophilus influenzae (including β-lactamase-producing strains),1 2 3 5 8 10 13 14 18 20 23 50 59 65 66 68 75 76 77 78 Moraxella catarrhalis (including β-lactamase-producing strains),1 2 3 5 13 20 23 58 59 66 75 77 78 Escherichia coli,1 and Proteus mirabilis.1 15 21 23 59 60 75 Also active in vitro against H. parainfluenzae,1 2 8 13 Klebsiella,1 Pasteurella multocida,1 P. vulgaris,1 Providencia,1 Salmonella,1 Shigella,1 and Serratia.1 Most Enterobacter5 60 75 and Pseudomonas are resistant.2 5 13 14 15 20 23 59 60 66 75 101
Advice to Patients
Advise patients that antibacterials (including cefixime) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).1
Importance of completing full course of therapy, even if feeling better after a few days.1
Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with cefixime or other antibacterials in the future.1
Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.1 Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.1
Importance of discontinuing cefixime and informing clinician if an allergic reaction occurs.1
Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
400 mg (of cefixime)
100 mg (of cefixime) per 5 mL
200 mg (of cefixime) per 5 mL
500 mg (of cefixime) per 5 mL
100 mg (of cefixime)
150 mg (of cefixime)
200 mg (of cefixime)
400 mg (of cefixime)
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2015. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Suprax 100MG/5ML Suspension (LUPIN PHARMACEUTICALS): 100/$293.93 or 300/$850.38
AHFS DI Essentials. © Copyright, 2004-2015, Selected Revisions October 1, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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