Adult: 0.5-1 g as a 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. Max: 12 g daily. Doses are given via slow 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: Dose is individualised according to the severity of the infection, sensitivity of the organism, and patient condition. >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 very severe cases; doses are given via slow IV inj over 3-5 minutes, IV infusion over 20-60 minutes or IM inj; 12-18 years or patients weighing ≥50 kg: Same as adult dose. Consider local treatment guidelines on the appropriate dosing recommendations.
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 slow 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: >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 very severe cases; doses are given via slow IV inj over 3-5 minutes, IV infusion over 20-60 minutes or IM inj; 12-18 years or patients weighing ≥50 kg: Same as adult dose. Consider local treatment guidelines on the appropriate dosing recommendations.
Intramuscular, Intravenous Prophylaxis of surgical infections
Adult: 1 g as a single dose 30-90 minutes prior to start of surgery via slow 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.
Intramuscular, Intravenous Bacterial meningitis
Adult: 6-12 g daily in divided doses 6-8 hourly via slow IV inj over 3-5 minutes, IV infusion over 20-60 minutes or IM inj. Child: Infants and children 200-225 mg/kg daily in divided doses 6-8 hourly, or up to 300 mg/kg daily in divided doses 4-6 hourly. Max: 12,000 mg daily. Doses are given via slow IV inj over 3-5 minutes, IV infusion over 20-60 minutes or IM inj. Dosage recommendations may vary among local guidelines (refer to specific country guidelines).
Intravenous Septicaemia
Adult: 2 g 6-8 hourly via slow IV inj over 3-5 minutes or IV infusion over 20-60 minutes. Max: 12 g daily.
Renal Impairment
Bone and joint infections; Genitourinary infections; Gynaecological infections; Lyme disease; Respiratory tract infections; Skin and skin structure 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
Adults: IV inj or infusion: 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. Alternatively, reconstitute with 10 mL sterile water for inj to a concentration of 50 mg/mL (0.5 g vial), 95 mg/mL (1 g vial), or 180 mg/mL (2 g vial); for the infusion, further dilute the reconstituted solution with up to 1,000 mL of compatible IV solution (e.g. NaCl 0.9% inj, 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 prepare a final concentration of approx 230 mg/mL, approx 300 mg/mL, or 330 mg/mL, respectively. Children: IV inj: Reconstitute vials with at least 10 mL sterile water for inj to a Max concentration of 200 mg/mL. Intermittent infusion: Reconstitute vials with sterile water for inj, then dilute the dose with compatible IV solution (e.g. NaCl 0.9% inj, dextrose 5% in water) to a final concentration of 10-40 mg/mL. IM inj: Reconstitute vials with sterile water for inj to a final concentration of 230-330 mg/mL. Recommendations for reconstitution, dilution and concentration may vary among individual products and countries (refer to detailed product or local guidelines).
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. Neonates and 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).
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: Mechanism of Action: Cefotaxime is a 3rd generation cephalosporin antibiotic that has bactericidal activity. It inhibits 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; penetrates the CSF particularly 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
Cefotaxime Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5742673, Cefotaxime. https://pubchem.ncbi.nlm.nih.gov/compound/Cefotaxime. Accessed Aug. 18, 2023.
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 NaCl 0.9% inj or dextrose 5% in water: Store at room temperature for 24 hours, or for 5 days when refrigerated.
J01DD01 - cefotaxime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
References
Tunkel AR, Hartman BJ, Kaplan SL et al. Practice Guidelines for the Management of Bacterial Meningitis. Clinical Infectious Diseases. 2004 Nov;39(9):1267-1284. https://doi.org/10.1086/425368. Accessed 23/05/2023. PMID: 15494903Workowski KA, Bachmann LH, Chan PA et al. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi: 10.15585/mmwr.rr7004a1. Accessed 23/05/2023Committee on Infectious Diseases, American Academy of Pediatrics, Kimberlin DW, Barnett ED, Lynfield R, Sawyer MH. "Tables of Antibacterial Drug Dosages", Red Book: 2021-2024 Report of the Committee on Infectious Diseases. American Academy of Pediatrics [online]. Accessed 19/04/2023.Anon. Cefotaxime (Pediatric and Neonatal Lexi-Drugs). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/04/2023.Anon. Cefotaxime. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 19/04/2023.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 19/04/2023.Cefotaxime 500 mg Powder for Solution for Injection (Cox Pharmaceutical Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 19/04/2023.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 (Hikma Pharmaceuticals USA Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 19/04/2023.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.Cefotaxime. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 19/04/2023.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.Paediatric Formulary Committee. Cefotaxime. BNF for Children [online]. London. BMJ Group, Pharmaceutical Press, and RCPCH Publications. https://www.medicinescomplete.com. Accessed 19/04/2023.Rekaxime Injection (Duopharma [M] Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 19/04/2023.
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