CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical safety rating
safeNo 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. |
| Molecular Weight | 455.45 |
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 | No adequate and well-controlled studies in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Use only if clearly needed and potential benefit justifies potential risk to the fetus. |
| 2nd trimester | Safe use during second trimester has not been established; however, cephalosporins are generally considered low risk. Use when clearly indicated. |
| 3rd trimester | Generally considered safe; no known association with teratogenicity. Use when clinically indicated. |
Clinical note
No significant drug interactions Can cause hypernatremia and fluid overload.
| FDA category | Animal |
| Placental transfer | Cefotaxime crosses the placenta with fetal serum levels approximately 30-50% of maternal serum levels. |
| Breastfeeding | Cefotaxime is excreted into human milk in small amounts. It is not expected to cause adverse effects in nursing infants. Caution is advised, especially with high maternal doses or prolonged therapy. |
| Lactation Rating | L1 (Safe) |
| 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. |
| 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. |
■ FDA Black Box Warning
No FDA black box warning.
| Common Effects | fluid replacement |
| Serious Effects |
Hypersensitivity to cefotaxime or any cephalosporinImmediate-type hypersensitivity (e.g., anaphylactic reaction) to penicillins
| 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. |
| Food/Dietary | Avoid alcohol and alcohol-containing foods or medications (e.g., mouthwash, cough syrups) during treatment and for 72 hours after stopping due to risk of disulfiram-like reaction. No other food interactions known. |
| Clinical Pearls | Claforan (cefotaxime) is a third-generation cephalosporin with broad-spectrum gram-negative coverage, including many Enterobacteriaceae. In sodium chloride 0.9% (NS), it is stable for 24 hours at room temperature. Administer over 30 minutes for intermittent infusion. Note: Cross-allergenicity with penicillins occurs in ~10% of patients; use caution. Monitor renal function in elderly and high-dose therapy. For surgical prophylaxis, give within 60 minutes before incision. May cause a disulfiram-like reaction with alcohol due to the NMTT side chain. Adjust dose in severe renal impairment (CrCl <20 mL/min: decrease dose or extend interval). |
| Patient Advice | Do not drink alcohol or take any products containing alcohol while on this medication and for 72 hours after stopping; doing so may cause severe nausea, vomiting, flushing, and headache. · Complete the full course of antibiotics as prescribed, even if you feel better. · Report any signs of allergic reaction such as rash, itching, swelling, or difficulty breathing immediately. · Notify your doctor if you experience severe diarrhea, especially watery or bloody stools, which may indicate C. difficile infection. · This medication is given intravenously; do not mix with other medications unless instructed by your healthcare provider. |
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