CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER (CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER).
Cefotaxime is a third-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), blocking transpeptidation, and activating autolytic enzymes.
| Metabolism | Partially hepatic via esterases to active metabolite desacetylcefotaxime; also undergoes renal tubular secretion and glomerular filtration. |
| Excretion | Primarily renal: approximately 60-80% of the dose is excreted unchanged in urine via glomerular filtration and tubular secretion. Small amounts are eliminated in bile (<10%) and feces (<1%). |
| Half-life | Terminal elimination half-life is approximately 0.6-1.2 hours in adults with normal renal function. In neonates, it is prolonged (2-6 hours). In renal impairment, half-life extends significantly (up to 15-30 hours in anuria), requiring dose adjustment. |
| Protein binding | Approximately 30-50% bound to serum proteins, primarily albumin. Binding is saturable and reversible. |
| Volume of Distribution | Volume of distribution is approximately 0.2-0.4 L/kg in adults, indicating distribution primarily into extracellular fluid. Vd increases in neonates and patients with edema. |
| Bioavailability | Not orally bioavailable due to poor absorption. Intramuscular administration yields nearly 100% bioavailability. Intravenous administration results in complete bioavailability. |
| Onset of Action | After intravenous administration, bactericidal serum concentrations are achieved within minutes; peak levels occur at end of infusion. Intramuscular administration yields peak concentrations in 0.5-2 hours. |
| Duration of Action | Due to short half-life, dosing every 6-8 hours is typically required for sustained bactericidal concentrations. In severe infections, continuous infusion or more frequent dosing may be used. |
| Molecular Weight | 455.44 |
1-2 g IV/IM every 8-12 hours; maximum 12 g/day for severe infections.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl 10-30 mL/min: 1 g every 12 hours; CrCl <10 mL/min: 1 g every 24 hours. |
| Liver impairment | No adjustment required; cefotaxime metabolism minimally affected, but monitor in severe impairment. |
| Pediatric use | Neonates (0-7 days): 50 mg/kg IV/IM every 12 hours; Infants (1-4 weeks): 50 mg/kg every 8 hours; Children >1 month: 50-180 mg/kg/day divided every 6-8 hours, max 12 g/day. |
| Geriatric use | No specific adjustment; dose based on renal function, consider CrCl. |
| 1st trimester | Cefotaxime is generally considered safe; animal studies have not shown fetal harm, but adequate human studies are limited. Use only if clearly needed. |
| 2nd trimester | Cefotaxime crosses the placenta and is used for treating maternal infections; no known teratogenic risk. Use when indicated. |
| 3rd trimester | Cefotaxime is used for Group B Streptococcus prophylaxis in labor; no known adverse fetal effects. |
Clinical note
Comprehensive clinical and safety monograph for CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER (CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER).
| Placental transfer | Cefotaxime crosses the placental barrier; placental transfer is moderate, achieving therapeutic concentrations in fetal plasma. |
| Breastfeeding | Cefotaxime is excreted into breast milk in small amounts (approximately 0.5% of maternal dose) and is unlikely to cause adverse effects in the infant. Caution is advised in infants with G6PD deficiency or known hypersensitivity. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Known hypersensitivity to cefotaxime or any cephalosporinHistory of severe immediate hypersensitivity (e.g., anaphylaxis) to penicillins or other beta-lactams
| Precautions | Hypersensitivity reactions (including anaphylaxis, Stevens-Johnson syndrome), Clostridioides difficile-associated diarrhea (CDAD), Seizures, especially in patients with renal impairment or CNS disorders, Superinfection with resistant organisms (including Pseudomonas, Candida), Hemolytic anemia (reported with cephalosporins), Drug-induced immune thrombocytopenia (rare), Prolonged use may lead to bleeding (vitamin K deficiency) |
| Food/Dietary | No significant food interactions. May be taken without regard to meals. |
Loading safety data…
| Lactation Rating | L2 (Probably Compatible) |
| Teratogenic Risk | Cefotaxime is classified as FDA Pregnancy Category B. Animal studies have not demonstrated fetal risk, but no adequate human studies in pregnant women. There is no evidence of teratogenicity in first trimester; however, use only if clearly needed. In second and third trimesters, no known fetal harm; crosses placenta but considered safe. |
| Fetal Monitoring | Monitor maternal renal function (creatinine clearance, BUN) as dose adjustment may be needed in severe impairment. Monitor for signs of superinfection or allergic reaction. In neonates, monitor for potential alteration in intestinal flora (diarrhea, candidiasis) if mother is breastfeeding. No specific fetal monitoring required. |
| Fertility Effects | No adverse effects on fertility reported in animal studies. No human data available. Cefotaxime does not affect spermatogenesis or oogenesis in preclinical models. |
| Clinical Pearls | CLAFORAN (cefotaxime) in D5W is a third-generation cephalosporin with broad Gram-negative coverage. Reconstitute according to manufacturer guidelines; do not use if solution is cloudy or contains precipitate. Administer IV over 30 minutes. Monitor for hypersensitivity reactions, especially in penicillin-allergic patients. Adjust dose in renal impairment (CrCl <20 mL/min). May cause false-positive urine glucose tests with copper sulfate methods. Not active against MRSA, enterococci, or anaerobes. |
| Patient Advice | Take this medication exactly as prescribed by your healthcare provider. · Notify your doctor if you have a history of allergies, especially to penicillins or cephalosporins. · Report any signs of allergic reaction: rash, hives, difficulty breathing, or swelling of face/mouth. · Complete the full course of therapy even if you feel better. · Diarrhea, especially if watery or bloody, may indicate C. difficile infection; contact your doctor. · Use effective contraception during treatment if applicable. |