CEFOTAN IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CEFOTAN IN PLASTIC CONTAINER (CEFOTAN IN PLASTIC CONTAINER).
Cefotetan is a cephamycin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), thereby inhibiting transpeptidation and cross-linking of peptidoglycan. It has broad-spectrum activity against gram-negative and gram-positive bacteria, including anaerobes, and is resistant to beta-lactamases.
| Metabolism | Cefotetan is not significantly metabolized; it is excreted primarily unchanged in the urine via glomerular filtration and tubular secretion. Approximately 20% is metabolized via hepatic esterases to a less active metabolite. |
| Excretion | Primarily renal (76-85% unchanged in urine via glomerular filtration and tubular secretion); biliary excretion accounts for <10%, with small amounts in feces. |
| Half-life | 2.8-3.2 hours in normal renal function; prolonged to 12-30 hours in severe renal impairment (CrCl <10 mL/min). |
| Protein binding | 78-91% bound to serum proteins, primarily albumin. |
| Volume of Distribution | 0.6-0.7 L/kg; indicates distribution into extracellular fluid and tissues. |
| Bioavailability | 100% after intravenous administration. |
| Onset of Action | Intravenous administration achieves therapeutic concentrations within 30 minutes. |
| Duration of Action | 12 hours; allows twice-daily dosing for most infections. |
1 to 2 g intravenously or intramuscularly every 12 hours for 5 to 10 days. Maximum dose 6 g daily.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl 30-50 mL/min: 1-2 g every 24 hours. CrCl 10-29 mL/min: 1-2 g every 48 hours. CrCl <10 mL/min: 1-2 g every 48 hours. Hemodialysis: administer dose after dialysis. |
| Liver impairment | No specific adjustment required for Child-Pugh A or B. For Child-Pugh C, use with caution and monitor for adverse effects. |
| Pediatric use | Infants and children >1 month: 20-40 mg/kg IV/IM every 12 hours. Maximum dose 2 g/dose. For severe infections: 40-60 mg/kg every 12 hours. |
| Geriatric use | No specific dose adjustment based solely on age. Adjust dose for renal function as per renal adjustment guidelines. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CEFOTAN IN PLASTIC CONTAINER (CEFOTAN IN PLASTIC CONTAINER).
| Breastfeeding | Cefotetan is excreted in human milk in low concentrations. M/P ratio not reported. Considered compatible with breastfeeding due to poor oral bioavailability and minimal infant exposure. Caution in infants with hypersensitivity or diarrhea. |
| Teratogenic Risk | FDA Pregnancy Category B. No evidence of teratogenicity in animal studies. Adequate well-controlled studies in pregnant women are lacking. Use only if clearly needed. First trimester: No known risk; Second and third trimesters: No known risk. |
■ FDA Black Box Warning
WARNING: Cefotetan may cause severe and sometimes fatal bleeding events, including hypoprothrombinemia and hemorrhage, particularly in patients with renal impairment, elderly, malnourished, or receiving anticoagulants. Vitamin K administration may be necessary. Coagulation parameters should be monitored.
| Serious Effects |
["Hypersensitivity to cefotetan or other cephalosporins","Known anaphylactic reaction to penicillins (contraindicated if immediate-type hypersensitivity)","Cefotetan should not be used in patients with a history of severe bleeding disorder"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis; cross-allergenicity with penicillins","Bleeding risk: hypoprothrombinemia and hemorrhage; monitor PT/INR; administer vitamin K if needed","Clostridioides difficile-associated diarrhea","Renal impairment: dose adjustment required; monitor renal function","Superinfection with prolonged use","Drug-induced hemolytic anemia (rare)"] |
| Food/Dietary | No known food interactions beyond the need to avoid alcohol. Cefotan may be given without regard to meals. |
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| Fetal Monitoring |
| Monitor for signs of hypersensitivity reactions (rash, urticaria, anaphylaxis). Monitor renal function and coagulation parameters (prothrombin time) due to potential hypoprothrombinemia. Assess for superinfection during prolonged therapy. |
| Fertility Effects | No human data on fertility effects. Animal studies showed no impairment of fertility. |
| Clinical Pearls | Cefotan (cefotetan) is a second-generation cephalosporin with potent anaerobic activity, similar to cefoxitin. It is associated with a disulfiram-like reaction when alcohol is consumed; avoid alcohol for at least 72 hours after infusion. Monitor renal function; dose adjustment required for CrCl <30 mL/min. Cefotan may prolong prothrombin time; consider vitamin K prophylaxis in malnourished or elderly patients. Use cautiously in patients with penicillin allergy (cross-sensitivity ~10%). |
| Patient Advice | Do not drink alcohol while taking this medication and for 3 days after stopping, as it may cause severe nausea, vomiting, headache, and flushing. · Report any signs of bleeding (easy bruising, dark stools, blood in urine) or unusual tiredness. · Complete the full course of therapy even if you feel better. · Inform your doctor if you have kidney disease, a history of colitis, or an allergy to penicillins or cephalosporins. · This medication is given intravenously; do not skip doses. If a dose is missed, contact your healthcare provider. |