Cefotaxime


Generic Medicine Info
Indications and Dosage
Intramuscular, Intravenous
Intra-abdominal infections
Adult: Dose is individualised according to the severity of the infection, sensitivity of the organism, and patient condition. In combination with another antibiotic: Usual dose: 1 g 12 hourly, may be increased to 1-2 g 8 hourly for moderate to severe cases. Max: 12 g daily. Doses are given via intermittent IV inj over 3-5 minutes, IV infusion over 20-60 minutes or IM inj. Consider local treatment guidelines on the appropriate dosing recommendations.
Child: In combination with another antibiotic: 0-27 days 50 mg/kg daily in 2-4 divided doses via IV, may be increased to 150-200 mg/kg daily in divided doses in severe cases; 28 days to 11 years <50 kg: Usual dose: 50-180 mg/kg daily in 2-6 divided doses, may be increased up to 200 mg/kg daily in 2-4 divided doses in severe cases; doses are given via intermittent IV inj over 3-5 minutes, IV infusion over 20-60 minutes or IM inj; 12-18 years or weighing ≥50 kg: Same as adult dose. Consider local treatment guidelines on the appropriate dosing recommendations.

Intramuscular, Intravenous
Gonorrhoea
Adult: 0.5-1 g as single dose via IV or IM administration.

Intramuscular, Intravenous
Bone and joint infections, Genitourinary infections, Gynaecological infections, Lyme disease, Respiratory tract infections, Skin and skin structure infections
Adult: Dose is individualised according to the severity of the infection, sensitivity of the organism, and patient condition. Usual dose: 1 g 12 hourly, may be increased to 1-2 g 8 hourly for moderate to severe cases. Doses are given via intermittent IV inj over 3-5 minutes, IV infusion over 20-60 minutes or IM inj. Max: 12 g daily. Consider local treatment guidelines on the appropriate dosing recommendations.
Child: Dose is individualised according to the severity of the infection, sensitivity of the organism, and patient condition. 0-27 days 50 mg/kg daily in 2-4 divided doses via IV administration, may be increased to 150-200 mg/kg daily in divided doses in severe cases; 28 days to 11 years <50 kg: Usual dose: 50-180 mg/kg daily in 2-6 divided doses, may be increased up to 200 mg/kg daily in 2-4 divided doses in severe cases; doses are given via intermittent IV inj over 3-5 minutes, IV infusion over 20-60 minutes or IM inj; 12-18 years or weighing ≥50 kg: Same as adult dose. Consider local treatment guidelines on the appropriate dosing recommendations.

Intramuscular, Intravenous
Bacterial meningitis
Adult: 6-12 g daily in divided doses 6-8 hourly via intermittent IV inj over 3-5 minutes, IV infusion over 20-60 minutes or IM inj.
Child: 0-7 days 50 mg/kg 12 hourly; 8-28 days 50 mg/kg 8 hourly; 1 month to 12 years 150-200 mg/kg in divided doses 6-8 hourly; doses are given via intermittent IV inj over 3-5 minutes, IV infusion over 20-60 minutes or IM inj; >12 years Same as adult dose.

Intramuscular, Intravenous
Prophylaxis of surgical infections
Adult: 1 g as single dose 30-90 minutes prior to start of surgery via intermittent IV inj over 3-5 minutes, IV infusion over 20-60 minutes or IM inj. If the operation time exceeds 90 minutes, an additional prophylactic dose of antibiotic may be given. In caesarean section: Initially, 1 g via IV administration as soon as the umbilical cord is clamped, then 1 g via IV or IM route at 6 and 12 hours following the 1st dose.

Intravenous
Septicaemia
Adult: Up to 6-8 g daily in 3-4 divided doses via bolus inj over 3-5 minutes or infusion over 15-30 minutes. Max: 12 g daily in up to 6 divided doses via IV administration.
Renal Impairment
Respiratory tract infections; Genitourinary infections; Lyme disease; Gynaecological infections; Skin and skin structure infections; Bone and joint infections; Intra-abdominal infections; Bacterial meningitis; Prophylaxis of surgical infections:
Patients on haemodialysis and peritoneal dialysis: 0.5-2 g via IV inj at the end of each session and repeated 24 hourly.
CrCl (mL/min) Dosage
≤5
Following the initial dose, reduce the succeeding doses by half without changes in dosing frequency.
Dosage recommendations may vary among countries and individual products (refer to detailed product guideline).

Septicaemia:
Dose reduction may be required.
Reconstitution
Intermittent IV inj: Reconstitute vials labelled as 0.5 g, 1 g, or 2 g with 2 mL, 4 mL, or 10 mL of sterile water for inj, respectively. Short IV infusion: Reconstitute vial labelled as 1 g or 2 g with 40-50 mL of the appropriate diluent. Continuous IV infusion: Reconstitute vial labelled as 2 g with 100 mL of appropriate diluent. Alternatively, reconstitute vials with at least 10 mL sterile water for inj to final concentration of 50 mg/mL (0.5 g vial), 95 mg/mL (1 g vial), or 180 mg/mL (2 g vial), then may further dilute up to 1,000 mL with appropriate solutions (e.g. 0.9% NaCl, dextrose 5% in water, Lactated Ringer's solution). IM inj: Reconstitute vials labelled as 0.5 g, 1 g, or 2 g with 2 mL, 3 mL, or 5 mL of sterile water for inj or bacteriostatic water for inj to a final concentration of approx 230 mg/mL, approx 300 mg/mL, or 330 mg/mL, respectively. IM inj may also be diluted with 1% lidocaine solution. Recommendations for reconstitution may vary among countries or individual products. Refer to detailed product guideline.
Incompatibility
Incompatible with aminoglycosides and alkaline solutions (e.g. Na bicarbonate).
Contraindications
Hypersensitivity to cefotaxime or other cephalosporins. History of acute or severe hypersensitivity reaction to penicillin or other β-lactam antibiotics. Concomitant use with bacteriostatic antibiotics (e.g. tetracyclines, erythromycin, chloramphenicol).
Special Precautions
Patient with asthma, allergic diathesis, history of gastrointestinal disease (particularly colitis). Renal impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Fungal or bacterial superinfection; serious bullous skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis); neutropenia, leucopenia, eosinophilia, thrombocytopenia, granulocytopenia, haemolytic anaemia (prolonged use); encephalopathy with focal motor status and generalised convulsion (in patients with renal insufficiency). Rarely, agranulocytosis (prolonged use).
Gastrointestinal disorders: Diarrhoea, nausea, vomiting, abdominal pain.
General disorders and administration site conditions: Inj site pain (IM); fever, inflammatory reactions at the inj site (e.g. phlebitis, thrombophlebitis).
Hepatobiliary disorders: Hepatitis (occasionally with jaundice).
Immune system disorders: Jarisch-Herxheimer reaction (in patients with Lyme disease).
Investigations: Increased BUN, liver enzymes (ALT, AST, alkaline phosphatase, gamma-glutamyl transferase, LDH).
Nervous system disorders: Headache, dizziness, convulsion.
Renal and urinary disorders: Decreased renal function, interstitial nephritis.
Reproductive system and breast disorders: Vaginitis.
Skin and subcutaneous tissue disorders: Pruritus, rash, urticaria.
Potentially Fatal: Hypersensitivity reactions (e.g. angioedema, bronchospasm, anaphylaxis), Clostridium difficile-associated diarrhoea, pseudomembranous colitis; arrhythmia (rapid bolus inj via central venous catheter).
IM/IV/Parenteral: B
Monitoring Parameters
Perform culture and susceptibility tests prior to therapy; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Monitor CBC with differential (particularly with prolonged use of >10 days) and renal function. Assess for signs or symptoms of anaphylaxis during initial dose.
Overdosage
Symptoms: Increased BUN and creatinine, and reversible encephalopathy. Management: Symptomatic and supportive treatment. May perform peritoneal dialysis or haemodialysis to reduce serum cefotaxime levels. Administer diazepam or phenobarbital for centrally mediated seizures.
Drug Interactions
May potentiate the nephrotoxic effect of aminoglycosides, furosemide, and other nephrotoxic drugs. Delayed excretion and increased plasma concentration with probenecid. May decrease the efficacy of oral contraceptives.
Potentially Fatal: May result in antagonistic effect with bacteriostatic antibiotics (e.g. tetracyclines, erythromycin, chloramphenicol).
Lab Interference
May cause positive Coomb's test. May lead to false-positive results in urinary glucose testing with non-specific reducing agents (e.g. Benedict's or Fehling's solution, Clinitest® tab).
Action
Description: Cefotaxime is a 3rd generation cephalosphorin antibiotic that has bactericidal activity. It inhibits the bacterial cell wall synthesis by binding to 1 or more penicillin-binding proteins (PBPs), thus inhibiting the final transpeptidation step of peptidoglycan synthesis in the cell walls. This action results in bacterial cell lysis and death.
Pharmacokinetics:
Absorption: Rapidly absorbed following IM inj. Time to peak plasma concentration: 30 minutes (IM); 4 hours (IV).
Distribution: Widely distributed into fluids and body tissues; passes the blood-brain barrier when meninges are inflamed. Crosses the placenta; enters breast milk (small amount). Plasma protein binding: Approx 31-50%.
Metabolism: Partially metabolised in the liver to O-desacetylcefotaxime (active) and inactive metabolites.
Excretion: Via urine (40-60% as unchanged drug; 20% as O-desacetylcefotaxime); faeces (approx 20%). Elimination half-life: Approx 1-1.5 hours (cefotaxime); 1.3-1.9 hours (O-desacetylcefotaxime).
Chemical Structure

Chemical Structure Image
Cefotaxime

Source: National Center for Biotechnology Information. PubChem Database. Cefotaxime, CID=5742673, https://pubchem.ncbi.nlm.nih.gov/compound/Cefotaxime (accessed on Jan. 21, 2020)

Storage
Store intact vials below 30°C. Protect from light. Reconstituted solutions: Store at room temperature for 12-24 hours, for 7-10 days when refrigerated, or for 13 weeks when frozen. IV infusions in 0.9% NaCl or dextrose 5% in water: Store at room temperature for 24 hours, or for 5 days when refrigerated.
MIMS Class
Cephalosporins
ATC Classification
J01DD01 - cefotaxime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
References
Anon. Cefotaxime. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/06/2021.

Buckingham R (ed). Cefotaxime Sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/06/2021.

Cefotaxime 500 mg Powder for Solution for Injection (Cox Pharmaceutical Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 03/06/2021.

Cefotaxime 500 mg Powder for Solution for Injection/Infusion (Noriderm Enterprises Limited). MHRA. https://products.mhra.gov.uk. Accessed 03/06/2021.

Cefotaxime Injection, Powder for Solution (West-Ward Pharmaceuticals Corp). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 03/06/2021.

Claforan 0.5 g, 1 g Injection (Sanofi-Aventis [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 03/06/2021.

Joint Formulary Committee. Cefotaxime. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/06/2021.

Disclaimer: This information is independently developed by MIMS based on Cefotaxime from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com
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