- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Powder for solution for injection or infusion of cefotaxime
Bone and joint infection
Prophylaxis against infection during surgical procedures
Respiratory tract infections - upper and lower
Skin and soft tissue infections
Urinary tract infection
The dosage, route and frequency of administration should be determined by the severity of infection, the sensitivity of causative organisms and condition of the patient.
Therapy may be initiated before the results of sensitivity tests are known.
Mild to moderate infections
1g every 12 hours.
Up to 12g daily, given in three or four divided doses.
For infections caused by sensitive Pseudomonas spp. daily doses of greater than 6g will usually be required.
Suspected meningococcal disease (when benzylpenicillin is not suitable)
1g by intravenous or intramuscular injection before urgent transfer to hospital.
500mg single dose intramuscularly.
Children aged over 12 years
(See Dosage; Adult)
Children aged 12 years and under:
100mg/kg to 150mg/kg daily in two to four divided doses. Dose may be increased to a maximum of 200mg/kg daily in severe infections.
The following alternative dosage schedule may be suitable:
Suspected meningococcal disease (when benzylpenicillin is not suitable)
50mg/kg by intravenous or intramuscular injection before urgent transfer to hospital.
Haemophilus influenzae exacerbations in cystic fibrosis (unlicensed)
50mg/kg every 6 to 8?hours, up to a maximum of 12g daily.
Mild to moderate infections
50mg/kg daily in two to four divided doses.
150mg/kg to 200mg/kg daily in divided doses.
The following alternative dosing schedule may be suitable:
Neonates aged 21 to 28 days: 25mg/kg every 6 to 8 hours.
Neonates aged 7 to 21 days: 25mg/kg every 8 hours.
Neonates aged up to 7 days: 25mg/kg every 12 hours.
Doses should be doubled in severe infections and meningitis.
Congenital gonococcal conjunctivitis (unlicensed)
100mg/kg (up to a maximum of 1g) as a single dose.
Patients with Renal Impairment
Severe renal impairment (GFR less than 5ml/minute)
Because of extra-renal elimination, it is only necessary to reduce the dosage of cefotaxime in severe renal failure.
After an initial loading dose of 1g, daily dose should be halved without change in the frequency of dosing, i.e. 1g every 12 hours, becomes 0.5g every 12 hours. 1g administered 8 hourly becomes 0.5g administered 8 hourly, etc.
For intravenous bolus injection, intravenous infusion or by intramuscular injection.
Following reconstitution, the solution should be injected into a vein over 3 to 5 minutes.
Following reconstitution, the solution should be injected deep into the muscle.
The prepared infusion may be administered over 20 to 60 minutes.
Precautions and Warnings
Restricted sodium intake
Renal impairment - glomerular filtration rate below 5 ml/min
Reduce dose in patients with glomerular filtration rate below 5 ml/min
Sodium content of formulation may be significant
Advise ability to drive/operate machinery may be affected by side effects
Before initiating therapy enquire about previous hypersensitivity reactions
Monitor blood count if treatment lasts more than 7 days
Consider pseudomembranous colitis if patient presents with diarrhoea
Prolonged use may result in superinfection with non-susceptible organisms
May affect results of some laboratory tests
Discontinue at once if pseudomembranous colitis occurs
Discontinue if clinical/laboratory evidence of neutropenia
Discontinue if drug-related rash or other hypersensitivity reactions occur
Cefotaxime constituted with lidocaine must never be used by the intravenous route, in infants under 30 months, in subjects with a previous history of hypersensitivity to this product, in patients who have an unpaced heart block or in patients with severe heart failure.
The sodium content (approximately 2.09 mmol/g) should be taken into account when prescribing to patients requiring sodium restriction.
Although any antibiotic may predispose to pseudomembranous colitis, the risk is higher with broad spectrum drugs, such as cephalosporins. This side effect, which may occur more frequently in patients receiving higher doses for prolonged periods, should be considered as potentially serious. The presence of Clostridium difficile toxin should be investigated, and treatment with cefotaxime stopped in cases of suspected colitis. Diagnosis can be confirmed by toxin detection and specific antibiotic therapy (e.g. oral metronidazole or vancomycin) should be initiated if considered clinically necessary. The administration of products that cause faecal stasis should be avoided.
Treatment should be discontinued if neutropenia (<1400 neutrophils/cubic millimetre) occurs.
Pregnancy and Lactation
Use cefotaxime with caution in pregnancy.
The safety of cefotaxime has not been established in human pregnancy. Cefotaxime crosses the placental barrier, thus should not be used in pregnancy unless the risk benefit ratio has been assessed. Cephalosporins are usually considered safe during pregnancy (Briggs, 2015).
Schaefer (2007) suggests that cephalosporins elimination is faster in pregnant women and it may therefore be necessary to adjust the dose.
Reproduction studies in mice and rats have found no evidence on impaired fertility or foetal harm at doses up to 20 times the human dose. During a large study in 2001 there was no detectable teratogenic risk with cefotaxime and other cephalosporins antibodies (Briggs, 2015).
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Use cefotaxime with caution in breastfeeding.
Cefotaxime is excreted into breast milk in low concentrations. Effects on the intestinal flora of the nursing infant (leading to diarrhoea, yeast-like fungal colonisation and sensitisation) cannot be excluded.
Briggs (2015) indicates that the nursing infant may experience problems associated with cefotaxime including direct effects on the infant and interference with the interpretation of culture results if a fever workup is required.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Arrhythmias after rapid bolus infusion through a central line
Increase in alkaline phosphatase
Increase in creatinine
Increase of liver transaminases
Inflammation (injection site)
Interstitial nephritis (reversible)
Local pain (injection site)
Serum bilirubin increased
Thrombophlebitis (injection site)
Toxic epidermal necrolysis
Effects on Laboratory Tests
A false positive Coombs test may be seen during treatment with cephalosporins. This phenomenon may occur during treatment with cefotaxime and can interfere with blood cross matching.
A false positive reaction to urinary glucose may occur with copper reduction methods (Benedicts, Fehling's or Clinitest) but not with the use of specific glucose oxidase methods.
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: August 2016
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Martindale: The Complete Drug Reference. 38th Edition. London: Brayfield A (ed). Pharmaceutical Press; 2014.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 June 2017
Summary of Product Characteristics: Cefotaxime for Injection 500mg + 1g. Wockhardt UK Ltd. Revised November 2015.
Summary of Product Characteristics: Cefotaxime for Injection 2g. Wockhardt UK Ltd. Revised November 2015.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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