PRECEF
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PRECEF (PRECEF).
Cefoperazone is a third-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis and death.
| Metabolism | Primarily excreted unchanged in bile; minor hepatic metabolism. Not significantly metabolized by cytochrome P450 enzymes. |
| Excretion | Primarily renal (80-90% as unchanged drug via glomerular filtration and tubular secretion); biliary/fecal <10%. |
| Half-life | 0.5-1 hour in adults with normal renal function; prolonged to 2-8 hours in moderate to severe renal impairment (CrCl <30 mL/min). |
| Protein binding | 20-30% bound to serum albumin. |
| Volume of Distribution | 0.15-0.25 L/kg, consistent with extracellular fluid distribution. |
| Bioavailability | Intramuscular: 90-100%. |
| Onset of Action | Intravenous: 2-5 minutes; Intramuscular: 10-30 minutes. |
| Duration of Action | 4-6 hours after IV/IM administration; sustained up to 12 hours in renal impairment. |
1-2 g IV every 6-8 hours; maximum 12 g/day.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl >50 mL/min: no adjustment. CrCl 10-50 mL/min: 1 g every 12-24 hours. CrCl <10 mL/min: 1 g every 24-48 hours. |
| Liver impairment | No specific Child-Pugh based adjustments; use caution in severe impairment. |
| Pediatric use | 50-100 mg/kg/day IV divided every 6-8 hours; maximum 12 g/day. |
| Geriatric use | Start at lower end of dosing range; adjust based on renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PRECEF (PRECEF).
| Breastfeeding | Excreted in breast milk in low concentrations (M/P ratio not established). Considered compatible with breastfeeding; monitor infant for gastrointestinal disturbances. |
| Teratogenic Risk | FDA Pregnancy Category B. No evidence of teratogenicity in animal studies; no adequate human studies. Caution in first trimester; weigh risk vs benefit. |
| Fetal Monitoring | Monitor maternal renal function and CBC; fetal growth ultrasound if used in severe infections during pregnancy. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to cefoperazone or other cephalosporins","Severe hypersensitivity to penicillins (cross-sensitivity possible)"]
| Precautions | ["Hypersensitivity reactions, including anaphylaxis, may occur","Pseudomembranous colitis has been reported","Bleeding risk due to hypoprothrombinemia (contains N-methylthiotetrazole side chain)","Disulfiram-like reaction with alcohol consumption"] |
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| Fertility Effects | No reported adverse effects on fertility in animal studies. |