CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical safety rating: safe
No significant drug interactions Can cause hypernatremia and fluid overload.
Cefotaxime is a third-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), disrupting peptidoglycan cross-linking, leading to cell lysis.
| Metabolism | Partially metabolized in the liver to desacetylcefotaxime (active metabolite), primarily excreted unchanged via kidneys. |
| Excretion | Renal: ~80-90% unchanged via glomerular filtration and tubular secretion. Biliary: <5%. Fecal: minimal. |
| Half-life | Terminal elimination half-life ~0.8-1.4 hours in adults with normal renal function. Prolonged to 4-8 hours in severe renal impairment (CrCl <20 mL/min). |
| Protein binding | ~35%, primarily to albumin. |
| Volume of Distribution | 0.25-0.5 L/kg in adults; higher in neonates (0.5-0.7 L/kg). Reflects distribution into extracellular fluid. |
| Bioavailability | IM: ~100%. |
| Onset of Action | IV: immediate; IM: 30-60 minutes. |
| Duration of Action | 6-8 hours after IM/IV administration; higher doses or renal impairment may prolong. |
1-2 g IV every 8 hours; maximum 12 g/day. For severe infections, 2 g every 8 hours.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl 50-80 mL/min: 1-2 g every 8-12 hours; CrCl 20-49 mL/min: 1-2 g every 12-24 hours; CrCl 5-19 mL/min: 1-2 g every 24 hours; CrCl <5 mL/min: 1-2 g every 48 hours. Hemodialysis: 1-2 g after each dialysis session. |
| Liver impairment | No adjustment required for Child-Pugh A. Child-Pugh B/C: No specific guidelines; monitor for adverse effects. |
| Pediatric use | Neonates 0-7 days: 50 mg/kg IV every 12 hours; Neonates 8-28 days: 50 mg/kg IV every 8 hours; Infants/children 1 month-12 years: 50 mg/kg IV every 8 hours (max 2 g/dose); Children >12 years: same as adult. |
| Geriatric use | No specific dose adjustment based on age alone; adjust dose based on renal function as per renal adjustment guidelines. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
No significant drug interactions Can cause hypernatremia and fluid overload.
| FDA category | Animal |
| Breastfeeding | Cefotaxime is excreted into human breast milk in low concentrations. The M/P ratio has not been established. It is generally considered compatible with breastfeeding due to low oral bioavailability in infants. Caution is advised with monitoring for potential effects on infant gastrointestinal flora. |
| Teratogenic Risk | Cefotaxime is classified as FDA Pregnancy Category B. Animal studies have not demonstrated teratogenic effects. There are no adequate and well-controlled studies in pregnant women. Risks to the fetus are considered low; however, cefotaxime should be used during pregnancy only if clearly needed. |
■ FDA Black Box Warning
No FDA black box warning.
| Common Effects | fluid replacement |
| Serious Effects |
Hypersensitivity to cefotaxime or any cephalosporin, history of severe immediate hypersensitivity reaction to penicillins or other beta-lactams.
| Precautions | Hypersensitivity reactions including anaphylaxis, Clostridioides difficile-associated diarrhea, seizures (especially in renal impairment), superinfection, prolonged use may lead to bacterial resistance, caution in patients with history of gastrointestinal disease (colitis), and renal impairment requires dose adjustment. |
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| Fetal Monitoring | Monitor maternal renal function and complete blood counts during prolonged therapy. Assess for signs of hypersensitivity reactions. Fetal monitoring is not routinely required but consider ultrasound if there are concerns about intrauterine infections. |
| Fertility Effects | Animal studies have not shown evidence of impaired fertility. There are no human data on the effects of cefotaxime on fertility; it is unlikely to have significant reproductive impact at therapeutic doses. |