CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER (CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER).
Cefotetan is a cephamycin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), resulting in cell lysis and death.
| Metabolism | Not metabolized; primarily eliminated unchanged in urine via glomerular filtration and tubular secretion. |
| Excretion | Primarily renal (unchanged drug) ~88%; minor biliary/fecal ~6-9%. |
| Half-life | Terminal elimination half-life 3-4 hours in normal renal function; prolonged in renal impairment (e.g., up to 13 hours in severe renal failure). |
| Protein binding | 68-90% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | 8-10 L (0.13-0.16 L/kg), indicating distribution primarily into extracellular fluid. |
| Bioavailability | Intravenous only; bioavailability 100%. |
| Onset of Action | Intravenous administration: rapid, within minutes; peak concentrations at end of infusion. |
| Duration of Action | Approximately 12 hours for susceptible bacteria; dosing every 12 hours recommended due to sustained bactericidal levels. |
| Molecular Weight | 575.62 |
1 to 2 g intravenously every 12 hours for 5 to 10 days. For severe infections, 2 g intravenously every 12 hours.
| Dosage form | INJECTABLE |
| Renal impairment | For CrCl 30-50 mL/min: 1-2 g every 24 hours. For CrCl 10-29 mL/min: 1-2 g every 48 hours. For CrCl <10 mL/min: 1-2 g every 48 hours. For hemodialysis: administer 25% of usual dose every 48 hours, or 1-2 g after dialysis. |
| Liver impairment | No specific adjustments for Child-Pugh class A or B; use with caution in severe hepatic impairment (Child-Pugh C) and monitor for bleeding risk due to vitamin K-dependent clotting factor inhibition. |
| Pediatric use | For neonates (1-4 weeks): 20 mg/kg every 12 hours. For infants and children (1 month to 18 years): 20-40 mg/kg every 12 hours, not to exceed adult dose of 2 g per dose. |
| Geriatric use | Dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased renal function; CrCl-based adjustment recommended. |
| 1st trimester | Avoid unless clearly needed; no adequate studies in pregnant women. Animal studies show no evidence of harm. |
| 2nd trimester | Use only if clearly indicated; crosses placenta. No known teratogenic effects in humans. |
| 3rd trimester | Use with caution; potential for adverse effects on fetal coagulation if given near term (vitamin K depletion). |
Clinical note
Comprehensive clinical and safety monograph for CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER (CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER).
| Placental transfer | Crosses placenta in therapeutic concentrations. Peak cord serum levels approximately 15-40% of maternal levels. |
| Breastfeeding | Cefotetan is excreted into breast milk in low concentrations; unlikely to cause significant adverse effects in nursing infants. However, may alter infant's gut flora. Use with caution. |
■ FDA Black Box Warning
Coagulation abnormalities, including hypoprothrombinemia and bleeding, have been reported with cefotetan. Vitamin K administration may be necessary in patients at risk. Cefotetan may cause hemolytic anemia, including severe cases with fatalities.
| Serious Effects |
Hypersensitivity to cefotetan or any cephalosporinSevere hypersensitivity to penicillins or other beta-lactams (possible cross-reactivity)
| Precautions | Hypersensitivity reactions, including anaphylaxis, may occur. Cross-allergenicity with penicillins and other beta-lactams., Clostridioides difficile-associated diarrhea (CDAD) reported; may range from mild diarrhea to fatal colitis., Coagulation abnormalities; monitor prothrombin time in patients with renal impairment, poor nutrition, or elderly., Hemolytic anemia; discontinue if signs or symptoms occur., Seizures may occur with high doses, especially in patients with renal impairment., Superinfection with non-susceptible organisms may occur. |
| Food/Dietary | Avoid ethanol and any foods/drugs containing alcohol (e.g., alcoholic beverages, mouthwash, some cough syrups, cooking wines) for at least 72 hours after the last dose due to disulfiram-like reaction risk. |
Loading safety data…
| Lactation Rating | L2 (Probably Compatible) |
| Teratogenic Risk | Cefotetan is a cephalosporin antibiotic classified as FDA Pregnancy Category B. Animal studies have not demonstrated fetal harm, but no adequate and well-controlled studies in pregnant women exist. Use only if clearly needed. No specific trimester risks identified. |
| Fetal Monitoring | Monitor for signs of hypersensitivity reactions, superinfection, and diarrhea. Routine monitoring for bleeding time or coagulation abnormalities is recommended due to cefotetan's N-methylthiotetrazole side chain. In pregnancy, monitor renal function and hematologic parameters. |
| Fertility Effects | No specific studies on fertility effects in humans. In animal studies, no impairment of fertility was observed. Reproductive impact is not expected at therapeutic doses. |
| Clinical Pearls | Cefotetan is a second-generation cephalosporin with anaerobic activity similar to cefoxitin, but it causes hypoprothrombinemia and disulfiram-like reactions with alcohol. Administer with vitamin K in high-risk patients. The duplex container provides a ready-to-use solution; do not add other drugs. Monitor renal function; dose adjustment required for CrCl <30 mL/min. |
| Patient Advice | Avoid alcohol and alcohol-containing products during treatment and for 72 hours after the last dose to prevent severe nausea, vomiting, and flushing (disulfiram-like reaction). · Inform your healthcare provider if you are taking blood thinners (e.g., warfarin) or have a history of bleeding problems; extra monitoring may be needed. · This medication is given intravenously; report any signs of injection site pain, swelling, or redness. · Complete the full course of therapy even if you feel better; do not skip doses. · Antibiotics may cause diarrhea; contact your doctor if you develop watery or bloody stools. |