Version November 2024
Usual dosage range: IM, IV: 1 to 2 g every 12 hours (maximum dose/day: IV: 6 g/day; IM: 4 g/day).
Pelvic inflammatory disease: IV: 2 g every 12 hours in combination with doxycycline. Total duration of therapy (which may include oral step-down therapy) is 14 days; oral therapy can usually be initiated within 24 to 48 hours of clinical improvement (Ref).
Skin and soft tissue infection:
Mild to moderate:
IM: 1 g every 12 hours.
IV: 1 g every 12 hours or 2 g every 24 hours.
Severe: IV: 2 g every 12 hours.
Surgical prophylaxis: IV: 2 g within 60 minutes prior to surgery. Doses may be repeated in 6 hours if procedure is lengthy or if there is excessive blood loss (Ref).
Urinary tract infection: IM, IV: 500 mg every 12 hours or 1 to 2 g every 12 to 24 hours.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
IM, IV:
Manufacturer’s labeling: Note: Renal function estimated using the Cockcroft-Gault formula:
CrCl >30 mL/minute: No dosage adjustment necessary.
CrCl 10 to 30 mL/minute: Administer usual dose every 24 hours or 50% of the usual dose administered every 12 hours
CrCl <10 mL/minute: Administer usual dose every 48 hours or 25% of the usual dose administered every 12 hours.
End-stage renal disease (ESRD) on intermittent hemodialysis: Dialyzable (5% to 20%); administer 25% the usual dose every 24 hours on days between dialysis; administer 50% the usual dose on the day of dialysis (administer after dialysis).
Alternate recommendations: Note: Renally adjusted dose recommendations are based on a dose of 1 to 2 g every 12 hours (Ref):
GFR >50 mL/minute/1.73 m2: No dosage adjustment necessary.
GFR 10 to 50 mL/minute/1.73 m2: Administer every 24 hours.
GFR <10 mL/minute/1.73 m2: Administer every 48 hours.
Peritoneal dialysis: 1 g every 24 hours
Continuous renal replacement therapy: Administer every 24 hours.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
(For additional information see "Cefotetan: Pediatric drug information")
General dosing, susceptible infection: Infants, Children, and Adolescents: IM, IV: 30 to 50 mg/kg/dose every 12 hours; maximum dose: 3,000 mg/dose (Ref).
Intra-abdominal infection: Limited data available: Note: Not recommended for empiric treatment due to high rates of resistant anaerobes, including Bacteroides fragilis, and potential for decreased efficacy.
Infants, Children, and Adolescents: IV: 20 to 40 mg/kg/dose every 12 hours (Ref).
Pelvic inflammatory disease: Limited data available: Children ≥45 kg and Adolescents: IV: 2,000 mg every 12 hours in combination with doxycycline for 14 days. Oral step-down therapy can usually be initiated within 24 to 48 hours of clinical improvement and may be used to complete 14-day treatment course (Ref).
Peritonitis, prophylaxis for patients receiving peritoneal dialysis undergoing GI or GU procedures: Limited data available: Infants, Children, and Adolescents: IV: 30 to 40 mg/kg administered 30 to 60 minutes before procedure; maximum dose: 2,000 mg/dose (Ref).
Surgical prophylaxis: Limited data available: Children and Adolescents: IV: 40 mg/kg within 60 minutes prior to procedure; may repeat dose in 6 hours for prolonged procedure or excessive blood loss; maximum dose: 2,000 mg/dose (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Infants, Children, and Adolescents: Dosage adjustments are not provided in the manufacturer's labeling; however, the following guidelines have been used by some clinicians (Ref). Note: Renally adjusted dose recommendations are based on doses of 20 to 40 mg/kg/dose every 12 hours:
GFR ≥30 mL/minute/1.73 m2: No adjustment required.
GFR 10 to 29 mL/minute/1.73 m2: 20 to 40 mg/kg/dose every 24 hours.
GFR <10 mL/minute/1.73 m2: 20 to 40 mg/kg/dose every 48 hours.
Intermittent hemodialysis: 20 to 40 mg/kg/dose every 48 hours; give after dialysis on dialysis days.
Peritoneal dialysis (PD): 20 to 40 mg/kg/dose every 48 hours.
Continuous renal replacement therapy (CRRT): 20 to 40 mg/kg/dose every 12 hours.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
1% to 10%:
Gastrointestinal: Diarrhea (1%)
Hepatic: Increased liver enzymes (1%; including increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase)
Hypersensitivity: Hypersensitivity reaction (1%)
<1%:
Dermatologic: Pruritus, skin rash
Endocrine & metabolic: Increased lactate dehydrogenase
Gastrointestinal: Nausea
Hematologic & oncologic: Eosinophilia, positive direct Coombs’ test, thrombocythemia
Local: Discomfort at injection site, injection-site phlebitis
Postmarketing:
Dermatologic: Urticaria
Gastrointestinal: Clostridioides difficile colitis
Hematologic & oncologic: Agranulocytosis, hemolytic anemia (Martin 2006), leukopenia, prolonged prothrombin time (Williams 1991), thrombocytopenia (Christie 1988)
Hypersensitivity: Anaphylaxis (Jeon 2018)
Renal: Increased blood urea nitrogen, increased serum creatinine, nephrotoxicity
Hypersensitivity to cefotetan, any component of the formulation, or other cephalosporins; previous cephalosporin-associated hemolytic anemia.
Concerns related to adverse effects:
• Elevated INR: May be associated with increased INR and subsequent bleeding, especially in nutritionally deficient patients, prolonged treatment, or patients with cancer, hepatic or renal disease. Monitor coagulation parameters and manage as clinically indicated (eg, administration of phytonadione).
• Hemolytic anemia: May rarely cause hemolytic anemia (including fatalities). Has been associated with a higher risk of hemolytic anemia relative to other cephalosporins (approximately threefold); monitor carefully during use and consider cephalosporin-associated immune anemia in patients who have received cefotetan within 2 to 3 weeks (either as treatment or prophylaxis). Discontinue drug, if applicable, and institute supportive measures as clinically indicated.
• Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, may occur. If an allergic reaction occurs, discontinue treatment and institute appropriate supportive measures.
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• GI disease: Use with caution in patients with a history of GI disease, particularly colitis.
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution Reconstituted, Injection:
Cefotan: 2 g (1 ea [DSC])
Solution Reconstituted, Injection [preservative free]:
Cefotan: 1 g (1 ea); 2 g (1 ea)
Generic: 1 g (1 ea); 2 g (1 ea)
Solution Reconstituted, Intravenous [preservative free]:
Generic: 1 g (1 ea [DSC]); 2 g (1 ea [DSC])
Yes
Solution (reconstituted) (Cefotan Injection)
1 g (per each): $30.28
2 g (per each): $60.55
Solution (reconstituted) (cefoTEtan Disodium Injection)
1 g (per each): $29.06
2 g (per each): $58.13
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IM: Inject deep IM into large muscle mass.
IV: Inject via direct IV over 3 to 5 minutes. Infuse via intermittent infusion over 30 minutes.
Parenteral:
IM: Inject deep IM into large muscle mass such as the upper outer quadrant of the gluteus maximus.
IV intermittent: Infuse over 20 to 60 minutes.
IV push: Inject over 3 to 5 minutes.
Bone and joint infection: Treatment of bone and joint infection caused by Staphylococcus aureus (methicillin susceptible). Note: In the native vertebral osteomyelitis guidelines, cefotetan is not recommended for the treatment of staphylococcal infection (Ref).
Gynecologic infection: Treatment of gynecologic infection caused by S. aureus (methicillin susceptible), Staphylococcus epidermidis (methicillin susceptible), Streptococcus spp., Streptococcus agalactiae, Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae, Bacteroides fragilis, Prevotella melaninogenica, Bacteroides vulgatus, Fusobacterium spp., and gram-positive anaerobic cocci (including Peptococcus niger and Peptostreptococcus spp.).
Limitations of use: Cefotetan has no activity against Chlamydia (Chlamydophila) trachomatis. When treating pelvic inflammatory disease, add appropriate antichlamydial coverage.
Lower respiratory tract infection: Treatment of lower respiratory tract infection caused by Streptococcus pneumoniae, S. aureus (methicillin susceptible), Haemophilus influenzae, Klebsiella spp. (including K. pneumoniae), E. coli, P. mirabilis, and Serratia marcescens.
Sepsis/septic shock: Treatment of confirmed or suspected sepsis, in combination with an aminoglycoside.
Skin and soft tissue infection: Treatment of skin and skin structure infection due to S. aureus (methicillin susceptible), S. epidermidis (methicillin susceptible), Streptococcus pyogenes, Streptococcus spp., E. coli, K. pneumoniae, P. niger, and Peptostreptococcus spp.
Surgical prophylaxis: Preoperative administration in surgical procedures that are classified as clean contaminated or potentially contaminated (eg, cesarean section, abdominal or vaginal hysterectomy, transurethral surgery, biliary tract surgery, GI surgery).
Urinary tract infection: Treatment of urinary tract infection caused by E. coli, Klebsiella spp. (including K. pneumoniae), P. mirabilis, Proteus vulgaris, Providencia rettgeri, and Morganella morganii.
CefoTEtan may be confused with ceFAZolin, cefOXitin, cefTAZidime, Ceftin, cefTRIAXone
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Alcohol (Ethyl): CefoTEtan may enhance the adverse/toxic effect of Alcohol (Ethyl). Risk C: Monitor therapy
Aminoglycosides: Cephalosporins may enhance the nephrotoxic effect of Aminoglycosides. Cephalosporins may decrease the serum concentration of Aminoglycosides. Risk C: Monitor therapy
Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Furosemide: May enhance the nephrotoxic effect of Cephalosporins. Risk C: Monitor therapy
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Mycophenolate: Antibiotics may decrease serum concentrations of the active metabolite(s) of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor therapy
Probenecid: May increase the serum concentration of Cephalosporins. Risk C: Monitor therapy
RifAMPin: Cephalosporins (N-methylthiotetrazole [NMTT] Side Chain Containing) may enhance the adverse/toxic effect of RifAMPin. Specifically, the risk for bleeding may be increased. Management: Avoid concomitant use of rifampin with cephalosporins that contain an N-methylthiotetrazole (NMTT) side chain when possible. If combined, closely monitor prothrombin time or other coagulation tests and administer vitamin K as needed. Risk D: Consider therapy modification
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Concurrent use with ethanol may cause a disulfiram-like reaction. Management: Monitor patients.
Cefotetan crosses the placenta and produces therapeutic concentrations in the amniotic fluid and cord serum. Cefotetan is one of the antibiotics recommended for prophylactic use prior to cesarean delivery.
Cefotetan is present in breast milk
Although the manufacturer recommends to use with caution, cephalosporins are generally considered acceptable for use in breastfeeding women (Ito 2000). In general, antibiotics that are present in breast milk may cause nondose-related modification of bowel flora. Monitor infants for GI disturbances, such as thrush or diarrhea (WHO 2002).
Some products may contain sodium.
Monitor renal, hepatic, and hematologic function periodically with prolonged therapy. Monitor prothrombin time in patients at risk of prolongation during cephalosporin therapy (nutritionally-deficient, prolonged treatment, renal or hepatic disease). Monitor for signs and symptoms of hemolytic anemia, including hematologic parameters where appropriate.
Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.
Distribution: Widely to body tissues and fluids including bile, gallbladder, kidney, skin, tonsils, uterus, sputum, prostatic and peritoneal fluids.
Protein binding: 88%.
Half-life elimination:
Infants and Children: 1.85 to 3.5 hours (Martin 1994).
Adults: 3 to 4.6 hours, prolonged in patients with moderately impaired renal function (up to 10 hours).
Time to peak, serum: IM: 1 to 3 hours.
Excretion: Urine (51% to 81%, as unchanged drug).
Anti-infective considerations:
Parameters associated with efficacy:
Time dependent; associated with time free drug concentration (fT) > minimum inhibitory concentration (MIC): Goal: ≥40% to 50% (fT) > MIC (bacteriostatic), ≥60% to 70% (fT) > MIC (bactericidal) (Abdul-Aziz 2020; Craig 1996; Craig 1998; Turnidge 1998).
Expected drug exposure in normal renal function:
Adults, Cmax (peak):
Single dose:
500 mg: ~69 to 79 mg/L (Liu 2020; Yates 1983).
1 g: ~126 to 142 mg/L (Liu 2020; Smith 1986; Yates 1983).
2 g: ~237 to 337 mg/L (Carver 1989; Liu 2020; Yates 1983).
Steady state: 1 g twice daily: 147.58 ± 22.71 mg/L (Liu 2020).
Postantibiotic effect: Generally <1 hour; varies based on organism (Craig 1991; Craig 1998). For Bacteroides spp, highly variable ranging from 0 to 36 hours (Siverhus 1988).
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