CLAFORAN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLAFORAN (CLAFORAN).
Cefotaxime is a bactericidal cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), thereby disrupting peptidoglycan cross-linking.
| Metabolism | Primarily metabolized by esterases in liver and tissues to desacetylcefotaxime (active metabolite); minimal hepatic CYP450 metabolism. |
| Excretion | Primarily renal (80-90% unchanged in urine via glomerular filtration and tubular secretion); biliary/fecal <10%. |
| Half-life | 0.8-1.4 hours in normal renal function (prolonged to 11-30 hours in severe renal impairment, CrCl <10 mL/min). No clinically relevant accumulation with standard dosing in renal impairment with dose adjustment. |
| Protein binding | 40-50% bound, primarily to albumin. |
| Volume of Distribution | 0.2-0.3 L/kg (low, indicating distribution limited to extracellular fluid). Higher in neonates (0.3-0.5 L/kg). |
| Bioavailability | IM: 90-100%; Oral: Not applicable (given parenterally). |
| Onset of Action | IV: Rapid, within minutes; IM: 15-30 minutes. |
| Duration of Action | 6-8 hours (bactericidal levels maintained for about 6-8 hours after a 1 g IV dose). |
1-2 g IV/IM every 8 hours. Maximum dose: 12 g/day in divided doses.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 50-80 mL/min: 1-2 g every 8 hours. GFR 30-50 mL/min: 1 g every 12 hours. GFR 10-30 mL/min: 1 g every 24 hours. GFR <10 mL/min: 0.5 g every 24 hours. For dialysis, administer 0.5-1 g after each hemodialysis session. |
| Liver impairment | No dose adjustment required for hepatic impairment. Cefotaxime is minimally hepatically metabolized. |
| Pediatric use | Neonates: 50 mg/kg IV/IM every 12 hours (postnatal age <7 days) or every 8 hours (postnatal age ≥7 days). Infants and children: 50-180 mg/kg/day IV/IM divided every 6-8 hours, depending on severity. Maximum 12 g/day. |
| Geriatric use | No specific dose adjustment based solely on age; base adjustment on renal function (see renal adjustment). Elderly often have reduced GFR; calculate creatinine clearance and adjust accordingly. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CLAFORAN (CLAFORAN).
| Breastfeeding | Excreted in breast milk in low concentrations (M/P ratio not established). Considered compatible with breastfeeding by AAP. Caution in neonates with G6PD deficiency or hyperbilirubinemia. |
| Teratogenic Risk | No evidence of teratogenicity in humans; animal studies show no fetal harm. FDA pregnancy category B. Crosses placenta, but risk of congenital anomalies is not increased. Use only if clearly needed. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA black box warnings.
| Serious Effects |
["Hypersensitivity to cefotaxime or any cephalosporin","History of severe immediate hypersensitivity (e.g., anaphylaxis) to penicillins or other beta-lactam antibiotics","Infants under 1 month of age (safety not established)"]
| Precautions | ["Hypersensitivity reactions (including anaphylaxis) in patients with penicillin or other beta-lactam allergies","Clostridioides difficile-associated diarrhea (CDAD)","Seizures and encephalopathy, especially in patients with renal impairment","Prolonged PT/increased bleeding risk with vitamin K deficiency","Risk of superinfection with prolonged use","Bacterial resistance: not effective against MRSA, enterococci, or anaerobes"] |
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| Monitor maternal renal and hepatic function. Assess for superinfection, bleeding, and diarrhea. Fetal monitoring not routinely required. |
| Fertility Effects | No known adverse effects on fertility in humans. Animal studies show no impairment of fertility. |