Cefotaxime


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV/IM Susceptible infections 1-2 g 8-12 hrly. Max: 12 g/day. Septicaemia Up to 6-8 g/day in 3-4 divided doses. Surgical prophylaxis 1 g 30-90 min before procedure. Gonorrhoea 0.5 g or 1 g as a single dose.
Dosage Details
Parenteral
Prophylaxis of surgical infections
Adult: 1 g 30-90 min before surgery by deep IM, slow IV inj over 3-5 min or IV infusion over 20-60 min. Caesarean section: 1 g IV as soon as the umbilical cord is clamped and 2 further IM or IV doses 6-12 hr later.

Parenteral
Septicaemia
Adult: Up to 6-8 g daily in 3-4 divided doses by deep IM, slow IV inj over 3-5 min or IV infusion over 20-60 min.

Parenteral
Bone and joint infections, Central nervous system infections, Genitourinary infections, Gynaecological infections, Intra-abdominal infections, Respiratory tract infections, Skin and skin structure infections
Adult: 1-2 g 8-12 hrly depending on the severity of the infection. May be given via deep IM inj, slow IV inj over 3-5 min or by IV infusion over 20-60 min. Max: 12 g daily.
Child: 0-1 wk 50 mg/kg/dose 12 hrly IV inj; >1-4 wk 50 mg/kg/dose 8 hrly IV inj; 1 mth to 12 yr <50 kg: 50-180 mg/kg IM or IV inj in 4-6 divided doses.

Parenteral
Gonorrhoea
Adult: 0.5 or 1 g as a single dose by deep IM, slow IV inj over 3-5 min or IV infusion over 20-60 min.
Special Patient Group
Critically ill patients undergoing renal replacement therapy: Continuous venovenous haemofiltration: 1-2 g 8-12 hrly. Continuous venovenous haemodialysis: 1-2 g 8 hrly. Continuous venovenous haemodiafiltration: 1-2 g 6-8 hrly. Intermittent haemodialysis: 1-2 g every 24 hr (after dialysis run).
Renal Impairment
Severe: After an initial loading dose of 1 g, half the daily dose w/o changing the frequency.
Reconstitution
Intermittent IV: Add 10 mL of sterile water for inj to a vial containing 0.5 g, 1 g or 2 g to provide a soln containing approx 50 mg, 95 mg, or 180 mg per mL, respectively. Intermittent or continuous IV infusion: Add 50 mL or 100 mL of NaCl 0.9% inj or dextrose 5% inj to an infusion bottle containing 1 g or 2 g. Alternatively, reconstituted soln may be further diluted w/ 50-1,000 mL of a compatible soln. IM: Add 2 mL, 3 mL or 5 mL of sterile or bacteriostatic water for inj to a vial containing 0.5 g, 1 g or 2 g to provide a soln containing approx 230 mg, 300 mg or 330 mg per mL, respectively.
Incompatibility
Incompatible w/ alkaline soln (e.g. Na bicarbonate inj), soln containing aminophylline, aminoglycosides. Y-site: Incompatible w/ allopurinol, azithromycin, filgrastim, fluconazole, gemcitabine, pantoprazole, pemetrexed, pentamidine, hetastarch in normal saline.
Contraindications
Hypersensitivity to cefotaxime or other cephalosporins.
Special Precautions
Patient w/ history of penicillin allergy and colitis. Renal impairment. Childn. Pregnancy and lactation.
Adverse Reactions
Rash (maculopapular or erythematous), pruritus, fever, eosinophilia; inflammation, phlebitis, thrombophlebitis (IV); pain, induration, tenderness at inj site (IM); anorexia, diarrhoea, nausea, vomiting, abdominal pain; transient neutropenia, granulocytopenia, leucopenia, eosinophilia or thrombocytopenia; transient increases in BUN and/or serum creatinine concentrations and interstitial nephritis; hepatitis, jaundice, cholestasis; transient increases in serum AST, ALT, LDH, γ-GT, bilirubin, and alkaline phosphatase concentrations; headache, agitation, confusion, fatigue, nocturnal perspiration. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.
Potentially Fatal: Clostridium difficile-associated diarrhoea and colitis, arrhythmias, anaphylaxis.
IM/IV/Parenteral: B
MonitoringParameters
Monitor renal function, CBC w/ differential. Observe for signs and symptoms of anaphylaxis during 1st dose.
Overdosage
Symptoms: Elevations of BUN and creatinine. Risk of reversible encephalopathy. Management: Symptomatic and supportive treatment.
Drug Interactions
Increased risk of nephrotoxicity w/ aminoglycosides. Increased serum concentration w/ probenecid.
Lab Interference
Urinary glucose test using cupric sulfate (e.g. Benedict's or Fehling's tests soln, Clinitest®) may produce false-positive result. May induce a positive direct Coombs' test; false-positive serum or urine creatinine w/ Jaffe' reaction.
Action
Description: Cefotaxime binds to 1 or more of the penicillin-binding proteins (PBPs) which inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death.
Pharmacokinetics:
Absorption: Rapidly absorbed (IM). Time to peak plasma concentration: 30 min (IM), 4 hr (IV).
Distribution: Widely distributed into body tissues and fluids; occur in CSF esp when the meninges are inflamed. It crosses the placenta and enters breast milk (low concentrations). Plasma protein binding: Approx 40%.
Metabolism: Undergoes partial metabolism in the liver and converted to desacetylcefotaxime and inactive metabolites.
Excretion: Mainly via urine (approx 40-60% as unchanged drug, further 20% as desacetyl metabolite); bile (relatively high concentrations); faeces (approx 20%). Plasma half-life: Approx 1 hr (cefotaxime); approx 1.5 hr (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 between 15-30°C.
MIMS Class
References
Anon. Cefotaxime. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/11/2014.

Buckingham R (ed). Cefotaxime Sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/11/2014.

Claforan Injection (Sanofi-Aventis U.S. LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 06/11/2014.

Claforan Injection. U.S. FDA. https://www.fda.gov/. Accessed 06/11/2014.

Claforan Sterile and Injection. U.S. FDA. https://www.fda.gov/. Accessed 06/11/2014.

Joint Formulary Committee. Cefotaxime. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/11/2014.

McEvoy GK, Snow EK, Miller J et al (eds). Cefotaxime Sodium. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 06/11/2014.

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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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