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Cefotetan Disodium

Class: Cephamycins
Chemical Name: [6R - (6α,7α)] - 7 - [[[4 - (2 - Amino - 1 - carboxy - 2 - oxoethylidene) - 1,3 - dithietan - 2 - yl]carbonyl]amino] - 7 - methoxy - 3 - [[(1 - methyl - 1H - tetrazol - 5 - yl)thio]methyl] - 8 - oxo - 5 - thia - 1 - azabicyclo - [4.2.0]oct - 2 - ene - 2 - carboxylic acid disodium salt
CAS Number: 74356-00-6

Introduction

Antibacterial; β-lactam antibiotic; cephamycin.1 2 3 4 5 26 62 110 157

Uses for Cefotetan Disodium

Bone and Joint Infections

Treatment of bone and joint infections caused by Staphylococcus aureus.1 2 110 157

Gynecologic Infections

Treatment of gynecologic infections caused by susceptible S. aureus (including penicillinase-producing strains), S. epidermidis, Streptococcus agalactiae (group B streptococci), other streptococci (except enterococci), Escherichia coli, Neisseria gonorrhoeae, Proteus mirabilis, Bacteroides (except B. distasonis, B. ovatus, B. thetaiotaomicron), Fusobacterium, and gram-positive anaerobic cocci (including Peptococcus and Peptostreptococcus).1 2 66 110 157

Treatment of pelvic inflammatory disease (PID).344 346 419 Cefotetan (or cefoxitin) in conjunction with doxycycline considered a regimen of choice by CDC and others when a parenteral regimen indicated for treatment of PID.344 346 Because cefotetan (like cephalosporins) is not active against Chlamydia, concomitant use of a drug active against Chlamydia (e.g., doxycycline) is necessary when these organisms are suspected pathogens.1 110 157 344

Intra-abdominal Infections

Treatment of intra-abdominal infections caused by susceptible Streptococcus (except enterococci), E. coli, Klebsiella (including K. pneumoniae), Bacteroides (except B. distasonis, B. ovatus, B. thetaiotaomicron), or Clostridium.1 2 110 157

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May be effective for treatment of mild to moderate infections caused by B. fragilis,88 but other anti-infectives (e.g., metronidazole, clindamycin) preferred,88 97 especially for severe or life-threatening infections.88

IDSA states cefotetan not recommended for empiric treatment of intra-abdominal infections because of increasing prevalence of B. fragilis resistant to the drug.161

Respiratory Tract Infections

Treatment of lower respiratory tract infections caused by susceptible S. pneumoniae, S. aureus (including penicillinase-producing strains), Haemophilus influenzae (including ampicillin-resistant strains), E. coli, Klebsiella (including K. pneumoniae), P. mirabilis, or Serratia marcescens.1 2 53 110 157

Skin and Skin Structure Infections

Treatment of skin and skin structure infections caused by susceptible S. aureus (including penicillinase-producing strains), S. epidermidis, S. pyogenes (group A β-hemolytic streptococci), other streptococci (except enterococci), E. coli, K. pneumoniae, Peptococcus niger, or Peptostreptococcus.1 110 157

Urinary Tract Infections (UTIs)

Treatment of UTIs caused by susceptible E. coli, Klebsiella (including K. pneumoniae), P. mirabilis, P. vulgaris, Providencia rettgeri, or Morganella morganii.1 2 51 52 110 157

Should not be used alone for UTIs if Pseudomonas aeruginosa is a possible pathogen since most strains are resistant.2 88

Perioperative Prophylaxis

Perioperative prophylaxis in women undergoing hysterectomy1 2 67 110 157 360 374 or cesarean section.1 2 68 130 149 157 Cefazolin, cefotetan, cefoxitin, or ampicillin and sulbactam usually recommended for women undergoing vaginal, abdominal, or laparoscopic hysterectomy;360 374 cefazolin usually recommended for women undergoing cesarean section.360 374

Perioperative prophylaxis in patients undergoing colorectal or other GI surgery.1 2 69 72 110 157 360 374 Cefoxitin, cefotetan, cefazolin (in conjunction with metronidazole), ampicillin and sulbactam, or ertapenem usually recommended.360 374 Many clinicians recommend using both a parenteral and oral regimen (i.e., neomycin in conjunction with erythromycin or metronidazole and mechanical bowel preparation) for perioperative prophylaxis in patients undergoing colorectal surgery,153 360 374

Perioperative prophylaxis in patients undergoing uncomplicated (nonperforated) appendectomy.360 Cefoxitin, cefotetan, or cefazolin (in conjunction with metronidazole) usually recommended for patients undergoing appendectomy.360

Perioperative prophylaxis in patients undergoing biliary tract surgery.1 2 70 157 360 374 Cefazolin usually recommended for high-risk patients undergoing open biliary tract surgery;360 374 alternatives include cefotetan, cefoxitin, or ampicillin and sulbactam.360 374 Prophylaxis not considered necessary for low-risk patients undergoing elective laparoscopic cholecystectomy.360 374

Has been used for perioperative prophylaxis in patients undergoing transurethral surgery;1 2 71 110 157 not usually recommended for urinary tract surgery.360 374

Cefotetan Disodium Dosage and Administration

Administration

Administer by IV injection1 or infusion1 110 157 or by deep IM injection.1

IV route preferred for treatment of bacteremia, septicemia, or other severe or life-threatening infections and in patients with lowered resistance resulting from debilitating conditions (e.g., malnutrition, trauma, surgery, diabetes, heart failure, malignancy), particularly if shock is present or impending.1 110 157

For solution and drug compatibility information, see Compatibility under Stability.

IV Injection

Reconstitution

Vials containing 1 or 2 g of cefotetan: Reconstitute with 10 or 10–20 mL, respectively, of sterile water for injection to provide solution containing approximately 95 or 95–182 mg/mL, respectively.1 Shake to dissolve; let stand until clear.1

Rate of Administration

Inject appropriate dose of reconstituted solution directly into a vein over a 3- to 5-minute period or slowly into the tubing of a compatible IV solution.1

IV Infusion

IV infusions should preferably be given using butterfly or scalp vein-type needles.1 110 157 Other IV solutions flowing through a common administration tubing or set should be discontinued while cefotetan is infused.1 110 157

Reconstitution

Vials containing 1 or 2 g of cefotetan: Reconstitute with 10 or 10–20 mL, respectively, of sterile water for injection to provide solutions containing approximately 95 or 95–182 mg/mL, respectively.1 Shake to dissolve; let stand until clear.1

Pharmacy bulk package vial containing 10 g of cefotetan: Reconstitute with 50 or 100 mL of sterile water for injection, 5% dextrose injection, or 0.9% sodium chloride injection to provide solution containing approximately 180 or 95 mg/mL, respectively.110 Shake to dissolve; let stand until clear.110 Not intended for direct IV infusion; prior to administration, doses from reconstituted pharmacy bulk package vial must be further diluted in a compatible IV infusion solution within 4 hours.110 Transfer individual doses to a compatible IV solution using suitable sterile transfer device or dispensing set; do not use syringe with needle since leakage could occur.110 Consult manufacturer’s directions for additional information.110

Duplex drug delivery system containing 1 or 2 g of cefotetan powder and 50 mL of 3.58 or 2.08% dextrose injection, respectively, in separate chambers: Reconstitute (activate) according to the manufacturer’s directions.157 If refrigerated after reconstitution (see Storage under Stability), allow solution to reach room temperature prior to administration.157

Rate of Administration

Administer by IV infusion over 20–60 minutes.1 2 52 53 110

IM Administration

Administer IM injections deeply into a large muscle, such as upper outer quadrant of gluteus maximus.1 Use aspiration to ensure needle is not in a blood vessel.1

Reconstitution

Vials containing 1 or 2 g of cefotetan: Prepare IM injections by adding 2 or 3 mL of sterile or bacteriostatic water for injection, 0.9% sodium chloride injection, or 0.5 or 1% lidocaine hydrochloride injection to provide solutions containing approximately 400 or 500 mg/mL, respectively.1 Shake to dissolve; let stand until clear.1

Dosage

Available as cefotetan disodium; dosage expressed in terms of cefotetan.1 110 157

Pediatric Patients

General Pediatric Dosage
Mild to Moderate Infections in Children Beyond Neonatal Period
IV or IM

AAP recommends 60 mg/kg daily given in 2 divided doses.292

Severe Infections in Children Beyond Neonatal Period
IV or IM

AAP recommends 100 mg/kg daily given in 2 divided doses.292

Perioperative Prophylaxis
Colorectal Surgery, Appendectomy (Nonperforated), Biliary Tract, or Other GI Surgery
IV

Children ≥1 year of age: Some clinicians recommend 40 mg/kg given within 1 hour prior to incision.374

If procedure is prolonged >3–4 hours, major blood loss occurs, or other factors are present that shorten drug half-life, additional intraoperative doses may be given.360 374

Duration of prophylaxis should be <24 hours for most procedures;360 374 no evidence to support continuing prophylaxis after wound closure or until all indwelling drains and intravascular catheters are removed.360 374

Adults

General Adult Dosage
Less Severe Infections
IV or IM

1 or 2 g every 12 hours.1 110 157

Severe Infections
IV

2 g every 12 hours.1 110 157

Life-threatening Infections
IV

3 g every 12 hours.1 110 157

Gynecologic Infections
Pelvic Inflammatory Disease (PID)
IV

2 g every 12 hours;344 346 used in conjunction with IV or oral doxycycline (100 mg every 12 hours).344 346

Cefotetan may be discontinued 24–48 hours after clinical improvement occurs and oral doxycycline (100 mg every 12 hours) continued to complete 14 days of treatment.344 346

Skin and Skin Structure Infections
Mild to Moderate Infections
IV

1 g every 12 hours or 2 g every 24 hours.1 110 157 For infections caused by K. pneumoniae, 1 or 2 g every 12 hours.1 110 157

IM

1 g every 12 hours.1 For infections caused by K. pneumoniae, 1 or 2 g every 12 hours.1

Severe Infections
IV

2 g every 12 hours.1 110 157

Urinary Tract Infections (UTIs)
IV or IM

500 mg every 12 hours; 1 or 2 g every 12 hours; or 1 or 2 g every 24 hours.1 110 157

Perioperative Prophylaxis
Gynecologic and Obstetric Surgery
IV

Hysterectomy (vaginal, abdominal, laparoscopic): 1 or 2 g given within 0.5–1 hour prior to incision.1 110 157 360 374

Cesarean section: 1 or 2 g given within 0.5–1 hour prior to incision.1 110 157 360 374 Manufacturers recommend giving dose as soon as umbilical cord is clamped,1 110 157 but there is some evidence that giving dose prior to incision is more effective than after clamping.360 374

If procedure is prolonged >3–4 hours, major blood loss occurs, or other factors are present that shorten drug half-life, additional intraoperative doses may be given (e.g., every 6 hours, measured from time preoperative dose is initiated).360 374

Duration of prophylaxis should be <24 hours for most procedures; no evidence to support continuing prophylaxis after wound closure or until all indwelling drains and intravascular catheters are removed.360 374

Colorectal Surgery, Appendectomy (Nonperforated), Biliary Tract, or Other GI Surgery
IV

1 or 2 g given within 0.5–1 hour prior to incision.1 110 157 360 374

If procedure is prolonged >3–4 hours, major blood loss occurs, or other factors are present that shorten drug half-life, additional intraoperative doses may be given (e.g., every 6 hours, measured from time preoperative dose is initiated).360 374

Duration of prophylaxis should be <24 hours for most procedures; no evidence to support continuing prophylaxis after wound closure or until all indwelling drains and intravascular catheters are removed.360 374

Transurethral Surgery
IV

1 or 2 g given within 0.5–1 hour prior to incision.1 110 157

Prescribing Limits

Adults

Maximum 6 g daily.1 110 157

Special Populations

Renal Impairment

Adults with renal impairment: Dosage adjustments required based on Clcr.1 2 37 39 43 110 157 (See Table 1.)

Table 1. Dosage of Cefotetan for Adults with Renal Impairment139110157

Clcr (mL/min)

Dosage

>30

Usual dose every 12 hours

10–30

Usual dose every 24 hours or 50% of usual dose every 12 hours

<10

Usual dose every 48 hours or 25% of usual dose every 12 hours

Hemodialysis patients

25% of usual dose every 24 hours on days between dialysis and 50% of usual dose on the day of dialysis

Geriatric Patients

Cautious dosage selection because of age-related decreases in renal function.1 110 157 (See Renal Impairment under Dosage and Administration.)

Cautions for Cefotetan Disodium

Contraindications

  • Known hypersensitivity to cefotetan or cephalosporins.1 110 157

  • History of cephalosporin-associated hemolytic anemia.1 110 157

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.1 110 157 Careful observation of patient is essential.1 110 157 Institute appropriate therapy if superinfection occurs.1 110 157

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.1 110 157 302 303 304 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 cefotetan, and may range in severity from mild diarrhea to fatal colitis.1 110 157 302 303 304 C. difficile produces toxins A and B which contribute to development of CDAD;1 110 157 302 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.1 110 157

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.1 110 157 302 303 304 Obtain careful medical history since CDAD may occur as late as ≥2 months after anti-infective therapy is discontinued.1 110 157

If CDAD suspected or confirmed, discontinue anti-infective therapy not directed against C. difficile whenever possible.1 110 157 302 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.1 110 157 302 303 304

Hemolytic Anemia

Severe hemolytic anemia (including fatalities) reported rarely with cefotetan;1 110 114 117 118 119 120 127 157 hemolytic anemia reported in a few women undergoing obstetric and gynecologic procedures who received a single dose for perioperative prophylaxis.127 Similar immune-mediated hemolytic anemia reported with some cephalosporins (e.g., cefotaxime, ceftizoxime [no longer commercially available in the US], ceftriaxone).1 110 146 147 148 157

Periodically monitor for signs and symptoms of hemolytic anemia; assess hematologic parameters when appropriate.1 110 157

If hemolytic anemia develops within 2–3 weeks after initiation of cefotetan, the diagnosis of immune-mediated hemolytic anemia should be considered and the drug discontinued until the etiology of anemia is determined.1 110 157 Consider blood transfusions as needed.1 110 157

Prolonged PT

Prolonged PT (with or without bleeding) reported rarely.1 2 76 77 78 110 131 132 133 157

Monitor PT in patients at risk, including geriatric patients and those with renal or hepatic impairment, malnutrition, or cancer.1 110 132 133 157 Administer vitamin K when indicated.1 76 110 132 133 157

Sensitivity Reactions

Hypersensitivity Reactions

Possible hypersensitivity reactions, including rash (maculopapular or erythematous), pruritus, fever, eosinophilia, urticaria, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.1 110 157 a

If allergic reaction occurs, discontinue cefotetan and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).1 110 157

Cross-hypersensitivity

Partial cross-allergenicity among β-lactam antibiotics, including penicillins, cephalosporins, and cephamycins.1 37 60 110 157

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cefotetan, cephalosporins, penicillins, or other drugs.1 110 157 a Cautious use recommended in individuals hypersensitive to penicillins;1 110 157 a 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.a

General Precautions

History of GI Disease

Use with caution in patients with history of GI disease, particularly colitis.1 110 157 (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis [CDAD] under Cautions.)

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of cefotetan and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.1 110 157

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 110 157 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1 110 157

In certain serious infections when causative organism is unknown and in cases of confirmed or suspected gram-positive or -negative sepsis, concomitant use of an aminoglycoside may be indicated pending results of in vitro susceptibility tests.1 110 157 (See Aminoglycosides under Interactions.)

Patients with Diabetes

Like other dextrose-containing solutions, use Duplex drug delivery system containing 1 or 2 g of cefotetan powder and 50 mL of 3.58 or 2.08% dextrose injection, respectively, with caution in patients with overt or known subclinical diabetes mellitus or in patients with carbohydrate intolerance for any reason.157

Sodium Content

Contains approximately 80 mg (3.5 mEq) of sodium per g of cefotetan.1 110 157

Specific Populations

Pregnancy

Category B.1 110 157

Lactation

Distributed into milk in low concentrations; use with caution.1 110 157

Pediatric Use

Safety and efficacy not established in children.1 110 157 (See Pediatric Patients under Dosage and Administration.)

Geriatric Use

Safety and efficacy in those ≥60 years of age similar to that in younger adults, but possibility exists of greater sensitivity to the drug in some geriatric patients.1 110 157

Substantially eliminated by kidneys; risk of toxicity may be greater in those with impaired renal function.1 110 157 Select dosage with caution and consider monitoring renal function because of age-related decreases in renal function.1 110 157 (See Renal Impairment under Dosage and Administration.)

Renal Impairment

Decreased clearance and increased half-life.1 110 157

Reduce dosage in those with renal impairment.1 110 157 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

GI effects, hematologic effects (eosinophilia, positive direct Coombs test, thrombocytosis), elevated hepatic enzymes, hypersensitivity reactions, local reactions at administration site.1 110 157

Interactions for Cefotetan Disodium

Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Comments

Alcohol

Possibility of disulfiram-like reactions (flushing, sweating, headache, tachycardia) if alcohol ingested within 72 hours after cefotetan1 2 108 110 157

Avoid ingesting alcohol during and for 72 hours after cefotetan1 2 108 110

Appears to result from accumulation of acetaldehyde2 73 74 75

Aminoglycosides

Possible increased risk of nephrotoxicity1 61 110 157

In vitro evidence of additive or synergistic antibacterial activity against S. aureus and some gram-negative bacilli2 5 17 24 96

Closely monitor renal function if used concomitantly1 110 157

Administer separately; do not admix1 110 157

Probenecid

Concomitant probenecid does not appear to affect pharmacokinetics of cefotetan since the drug is excreted principally by glomerular filtration and nonrenal mechanisms87

Tests for creatinine

High concentrations may cause falsely elevated serum or urine creatinine values when the Jaffe reaction is used1 110 157

Tests for glucose

Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution1 110 157

Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix)1 110 157

Cefotetan Disodium Pharmacokinetics

Absorption

Bioavailability

Not absorbed from the GI tract; must be given parenterally.46

Appears to be completely absorbed following IM administration;2 41 peak plasma concentrations attained 1.5–4 hours after a dose.2 41 42 64

Distribution

Extent

Widely distributed into body tissues and fluids including gallbladder,2 64 80 skin,1 64 80 110 157 muscle,1 64 80 110 157 fat,1 64 80 110 157 myometrium,1 48 64 110 157 endometrium,1 48 64 79 110 157 fallopian tube,48 64 79 cervix,1 110 157 ovary,1 64 110 157 uterus and adnexa,64 81 prostatic tissue,2 64 kidney,1 64 110 157 ureter,1 64 110 157 bladder,1 64 110 157 maxillary sinus mucosa,1 110 157 tonsils,1 2 64 110 157 sputum,2 64 bile,1 2 37 46 64 110 157 and wound,2 80 prostatic,64 and peritoneal fluids.1 2 49 64 80 110 157

Only low concentrations attained in CSF.2 88

Crosses the placenta1 2 64 81 110 157 and is distributed into milk in low concentrations.1 2 64 110 157

Plasma Protein Binding

76–91%.1 2 5 26 37 38 57 64 110 157

Elimination

Metabolism

Does not appear to be metabolized,1 2 38 110 157 but 1–10% of a dose is present in plasma and urine as a tautomer of the drug.1 2 39 40 45 47 64 82 110 157 This tautomer has microbiologic activity and pharmacokinetics similar to cefotetan.1 39 44 64 82 110 157

Elimination Route

Eliminated principally in urine by glomerular filtration;1 2 37 38 39 40 41 42 47 64 82 110 157 also eliminated by biliary excretion.39 57 64

49–81% of a dose eliminated unchanged in urine;1 2 37 38 39 40 41 42 47 64 82 110 157 approximately 20% excreted in bile.57 64

Half-life

Adults with normal renal function: Distribution half-life 0.2–1.1 hours39 41 45 47 and elimination half-life 2.8–4.6 hours.1 2 37 38 39 41 42 45 47 57 64 82 110 157

Special Populations

Patients with impaired renal function: Renal elimination decreased, serum concentrations increased, and half-life prolonged.1 2 39 43 45 64 110 157 Half-life may be 10 hours in those with moderate renal impairment.1 110 157

Stability

Storage

Parenteral

Powder for Injection or IV Infusion

Vials containing 1 or 2 g of cefotetan: ≤22° C;1 protect from light.1

IV solutions containing 95–182 mg of cefotetan/mL prepared using sterile water are stable for 24 hours at 25°C, 96 hours when refrigerated at 5°C, or at least 1 week when frozen at -20°C.1 64 65

IM solutions containing 400 or 500 mg/mL prepared using sterile or bacteriostatic water, 0.9% sodium chloride, or 0.5 or 1% lidocaine hydrochloride are stable for 24 hours at 25°C, 96 hours when refrigerated at 5°C, or at least 1 week when frozen at -20°C.1 64 Reconstituted solutions transferred to disposable glass or plastic syringes are stable for 24 hours at room temperature or 96 hours when refrigerated.1

Powder and reconstituted solutions may darken to a deeper yellow; does not indicate loss of potency.64 87

Powder for IV Infusion

Pharmacy bulk package vial containing 10 g of cefotetan: 20–25°C;110 protect from light.110 Transfer reconstituted solution and dilute in compatible IV infusion solution within 4 hours after vial originally entered;110 discard any portion of reconstituted pharmacy bulk package not used within 4 hours.110 Following dilution in compatible IV infusion solution, use within 24 hours if stored at room temperature, within 96 hours if refrigerated at 5°C, or within 1 week if frozen.110

Duplex drug delivery system containing 1 or 2 g of cefotetan powder and 50 mL of dextrose injection in separate chambers: 20–25°C (may be exposed to 15–30°C).157 Following reconstitution (activation), use within 12 hours if stored at room temperature or within 5 days if stored in a refrigerator; do not freeze.157

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution CompatibilityHID

Compatible

Dextrose 5% in water

Sodium chloride 0.9%

Drug Compatibility
Y-site CompatibilityHID

Compatible

Allopurinol sodium

Amifostine

Aztreonam

Bivalirudin

Dexmedetomidine HCl

Diltiazem HCl

Docetaxel

Etoposide phosphate

Famotidine

Fenoldopam mesylate

Filgrastim

Fluconazole

Fludarabine phosphate

Gemcitabine HCl

Granisetron HCl

Heparin sodium

Hetastarch in lactated electrolyte injection (Hextend)

Insulin, regular

Linezolid

Melphalan HCl

Meperidine HCl

Morphine sulfate

Paclitaxel

Palonosetron HCl

Propofol

Remifentanil HCl

Sargramostim

Tacrolimus

Teniposide

Theophylline

Thiotepa

Incompatible

Pemetrexed disodium

Promethazine HCl

Vinorelbine tartrate

Variable

Vancomycin HCl

Actions and Spectrum

  • Cephamycin; sometimes classified as a second generation cephalosporin based on spectrum of activity.1 62 88 110 157

  • Usually bactericidal.1 2 3 5 13 64 110 157

  • Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.1 64 110 157

  • Spectrum of activity includes some gram-positive and -negative aerobic bacteria and some anaerobic bacteria; inactive against Chlamydia, fungi, and viruses.1 110 157

  • Gram-positive aerobes: Active in vitro and in clinical infections against S. aureus (including penicillinase-producing strains), S. epidermidis, S. pneumoniae, S. pyogenes (group A β-hemolytic streptococci), and S. agalactiae (group B streptococci).1 2 3 4 5 6 11 15 17 18 26 64 110 157 Oxacillin-resistant staphylococci (methicillin-resistant staphylococci) and most enterococci (e.g., Enterococcus faecalis) are resistant.1 2 3 4 5 6 11 17 18 64 110 157

  • Gram-negative aerobes: Active in vitro and in clinical infections against E. coli, H. influenzae (including ampicillin-resistant strains), Klebsiella (including K. pneumoniae), M. morganii, N. gonorrhoeae, P. mirabilis, P. vulgaris, P. rettgeri, and S. marcescens.1 157 Also active in vitro against Citrobacter, K. oxytoca, Moraxella catarrhalis, Salmonella, Shigella, and Yersinia enterocolitica.1 2 3 4 15 16 17 18 22 20 26 64 110 157 Many strains of Enterobacter (e.g., E. aerogenes, E. cloacae) and most Ps. aeruginosa and Acinetobacter are resistant.1 110 157

  • Anaerobes: Active in vitro and in clinical infections against Bacteroides fragilis,1 2 4 7 8 9 10 18 20 29 30 64 110 157 B. vulgatus,1 110 157 Prevotella bivia,1 2 4 9 10 20 30 64 110 157 P. disiens,1 2 4 9 10 20 30 64 110 157 P. melaninogenica,1 110 157 Fusobacterium,1 2 4 8 10 20 29 64 110 157 Clostridium (except C. difficile),1 110 157 Peptococcus,1 2 4 8 29 64 110 157 and Peptostreptococcus.1 2 4 5 8 9 20 29 64 110 157 Also active in vitro against B. splanchnicus,1 110 157 Prevotella oralis,1 110 157 Propionibacterium,1 2 8 32 110 157 and Veillonella.1 2 20 29 64 110 157

Advice to Patients

  • Advise patients that antibacterials (including cefotetan) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).1 110 157

  • Importance of completing full course of therapy, even if feeling better after a few days.1 110 157

  • 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 cefotetan or other antibacterials in the future.1 110 157

  • Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.1 110 157 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.1 110 157

  • Advise patients to avoid ingesting alcohol for 72 hours after cefotetan.1 110 157

  • Importance of informing clinicians if an allergic reaction occurs.1 110 157

  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.1 110 157

  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1 110 157

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Cefotetan Disodium in Dextrose

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection

1 g (of cefotetan)*

Cefotetan Disodium for Injection

2 g (of cefotetan)*

Cefotetan Disodium for Injection

For injection, for IV infusion

1 g (of cefotetan)*

Cefotetan Disodium for Injection (available in dual-chambered Duplex drug delivery system with 3.58% dextrose injection)

B Braun

2 g (of cefotetan)*

Cefotetan Disodium for Injection (available in dual-chambered Duplex drug delivery system with 2.08% dextrose injection)

B Braun

10 g (of cefotetan) pharmacy bulk package*

Cefotetan Disodium for Injection

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions October 3, 2014. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. APP Pharmaceuticals, LLC. Cefotetan for injection prescribing information. Schaumburg, IL; 2010 Sep.

2. Ward A, Richards DM. Cefotetan: a review of its antibacterial activity, pharmacokinetic properties and therapeutic use. Drugs. 1985; 30:382-426. [IDIS 207781] [PubMed 3905336]

3. Ayers LW, Jones RN, Barry AL et al. Cefotetan, a new cephamycin: comparison of in vitro antimicrobial activity with other cephems, β-lactamase stability, and preliminary recommendations for disk diffusion testing. Antimicrob Agents Chemother. 1982; 22:859-77. [IDIS 160705] [PubMed 6983862]

4. Philips I, King A, Shannon K et al. Cefotetan: in vitro antibacterial activity and susceptibility to β-lactamases. J Antimicrob Chemother. 1983; 11(Suppl A):1-9. [PubMed 6601650]

5. Grassi GG, Alesina R, Ferrara A et al. In-vitro antibacterial activity of cefotetan. J Antimicrob Chemother. 1983; 11(Suppl A):45-58. [PubMed 6573325]

6. Grimm H. Susceptibility of bacterial pathogens to cefotetan judged by MIC and disc tests. J Antimicrob Chemother. 1983; 11(Suppl A):37-43. [PubMed 6573324]

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