Drugs List

Therapeutic Indications

Uses

Bacterial endocarditis
Bacterial meningitis
Bone and joint infection
Gonorrhoea
Gynaecological infections
Lyme disease
Obstetric infections
Prophylaxis against infection during surgical procedures
Respiratory tract infections - upper and lower
Septicaemia
Skin and soft tissue infections
Urinary tract infection

Administration

For intravenous bolus injection, intravenous infusion or by intramuscular injection.

Intravenous injection
Following reconstitution, the solution should be injected into a vein over 3 to 5 minutes.

Intramuscular injection
Following reconstitution, the solution should be injected deep into the muscle.

Intravenous infusion
The prepared infusion may be administered over 20 to 60 minutes.

Contraindications

Severe neutropenia

Precautions and Warnings

Restricted sodium intake
Breastfeeding
Pregnancy
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

Pregnancy

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 ).

Lactation

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

Side Effects

Abdominal pain
Agranulocytosis
Anaphylaxis
Angioedema
Arrhythmias after rapid bolus infusion through a central line
Breathing difficulties
Bronchospasm
Bullous reactions
Candidiasis
Cholestatic jaundice
Convulsions
Diarrhoea
Dizziness
Drug fever
Encephalopathy
Eosinophilia
Erythema multiforme
Granulocytopenia
Haemolytic anaemia
Headache
Hepatitis
Hypersensitivity reactions
Impaired consciousness
Increase in alkaline phosphatase
Increase in creatinine
Increase of liver transaminases
Inflammation (injection site)
Interstitial nephritis
Interstitial nephritis (reversible)
Itching
Jarisch-Herxheimer reaction
Joint discomfort
Leucopenia
Local pain (injection site)
Nausea
Neurotoxicity
Neutropenia
Phlebitis
Pruritus
Pseudomembranous colitis
Rash
Renal impairment
Serum bilirubin increased
Stevens-Johnson syndrome
Superinfections
Thrombocytopenia
Thrombophlebitis (injection site)
Toxic epidermal necrolysis
Urticaria
Vomiting

Presentation

Powder for solution for injection or infusion of cefotaxime

Drugs List

Therapeutic Indications

Uses

Bacterial endocarditis
Bacterial meningitis
Bone and joint infection
Gonorrhoea
Gynaecological infections
Lyme disease
Obstetric infections
Prophylaxis against infection during surgical procedures
Respiratory tract infections - upper and lower
Septicaemia
Skin and soft tissue infections
Urinary tract infection

Dosage

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.

Adults

Children

Neonates

Patients with Renal Impairment

Administration

For intravenous bolus injection, intravenous infusion or by intramuscular injection.

Intravenous injection
Following reconstitution, the solution should be injected into a vein over 3 to 5 minutes.

Intramuscular injection
Following reconstitution, the solution should be injected deep into the muscle.

Intravenous infusion
The prepared infusion may be administered over 20 to 60 minutes.

Contraindications

Severe neutropenia

Precautions and Warnings

Restricted sodium intake
Breastfeeding
Pregnancy
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

Pregnancy

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 ).

Lactation

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

Side Effects

Abdominal pain
Agranulocytosis
Anaphylaxis
Angioedema
Arrhythmias after rapid bolus infusion through a central line
Breathing difficulties
Bronchospasm
Bullous reactions
Candidiasis
Cholestatic jaundice
Convulsions
Diarrhoea
Dizziness
Drug fever
Encephalopathy
Eosinophilia
Erythema multiforme
Granulocytopenia
Haemolytic anaemia
Headache
Hepatitis
Hypersensitivity reactions
Impaired consciousness
Increase in alkaline phosphatase
Increase in creatinine
Increase of liver transaminases
Inflammation (injection site)
Interstitial nephritis
Interstitial nephritis (reversible)
Itching
Jarisch-Herxheimer reaction
Joint discomfort
Leucopenia
Local pain (injection site)
Nausea
Neurotoxicity
Neutropenia
Phlebitis
Pruritus
Pseudomembranous colitis
Rash
Renal impairment
Serum bilirubin increased
Stevens-Johnson syndrome
Superinfections
Thrombocytopenia
Thrombophlebitis (injection site)
Toxic epidermal necrolysis
Urticaria
Vomiting

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.

Overdosage

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 ).

Further Information

Last Full Review Date: August 2016

Reference Sources

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.