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).

How it works

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.

What the body does with it

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.

Classification & Brands

Dosing & administration

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.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER (CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER).

Breastfeeding	Cefotaxime is excreted into human breast milk in low concentrations (M/P ratio ~0.1-0.3). Considered compatible with breastfeeding by the American Academy of Pediatrics. Use with caution in nursing mothers of infants with diarrhea, candidiasis, or known hypersensitivity to cephalosporins.
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.

Warnings & precautions

■ FDA Black Box Warning

No FDA black box warning.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to cefotaxime, any cephalosporin, or any component of the formulation","Immediate-type hypersensitivity reactions (e.g., anaphylaxis) to penicillins (cross-sensitivity)"]

Clinical Precautions

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)"]

Clinical Tips & Counseling

Drug interactions

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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).

How it works

What the body does with it

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.

Classification & Brands

Dosing & administration

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.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER (CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER).

Breastfeeding	Cefotaxime is excreted into human breast milk in low concentrations (M/P ratio ~0.1-0.3). Considered compatible with breastfeeding by the American Academy of Pediatrics. Use with caution in nursing mothers of infants with diarrhea, candidiasis, or known hypersensitivity to cephalosporins.
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.

Warnings & precautions

■ FDA Black Box Warning

No FDA black box warning.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to cefotaxime, any cephalosporin, or any component of the formulation","Immediate-type hypersensitivity reactions (e.g., anaphylaxis) to penicillins (cross-sensitivity)"]