Cefuroxime

Chemical formula: C₁₆H₁₆N₄O₈S  Molecular mass: 424.385 g/mol  PubChem compound: 5479529

Interactions

Cefuroxime interacts in the following cases:

Renal impairment, hemodialysis

Cefuroxime is primarily excreted by the kidneys. Therefore, as with all such antibiotics, in patients with markedly impaired renal function it is recommended that the dosage of cefuroxime should be reduced to compensate for its slower excretion.

Recommended doses for cefuroxime in renal impairment:

Creatinine clearanceT1/2(hrs) Dose (mg)
>20 mL/min/1.73 m²1.7–2.6It is not necessary to reduce the standard dose (750 mg to 1.5 g three times daily).
10-20 mL/min/1.73 m²4.3–6.5750 mg twice daily
<10 mL/min/1.73 m²14.8–22.3750 mg once daily
Patients on haemodialysis3.75A further 750 mg dose should be given intravenously or intramuscularly at the end of each dialysis; in addition to parenteral use, cefuroxime sodium can be incorporated into the peritoneal dialysis fluid (usually 250 mg for every 2 litres of dialysis fluid).
Patients in renal failure on continuous arteriovenous haemodialysis (CAVH) or high-flux haemofiltration (HF) in intensive therapy units7.9–12.6 (CAVH). 1.6 (HF) 750 mg twice daily; for low-flux haemofiltration follow the dosage recommended under impaired renal function.

Oral anticoagulants

Concomitant use with oral anticoagulants may give rise to increased international normalised ratio (INR).

Oral contraceptives

Cefuroxime may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.

Furosemide, aminoglycosides

High-dosage treatments with cephalosporins should be carried out with caution on patients who are taking strong-acting diuretics (such as furosemide) or potential nephrotoxic preparations (such as aminoglycoside antibiotics), since impairment of renal function through such combinations cannot be ruled out.

Probenecid

Cefuroxime is excreted by glomerular filtration and tubular secretion. Concomitant use of probenecid is not recommended. Concurrent administration of probenecid prolongs the excretion of the antibiotic and produces an elevated peak serum level.

Coombs test positive

The development of a positive Coombs Test associated with the use of cefuroxime may interfere with cross matching of blood.

Pregnancy

There are limited data from the use of cefuroxime in pregnant women. Studies in animals have shown no harmful effects on pregnancy, embryonal or foetal development, parturition or postnatal development. Cefuroxime should be prescribed to pregnant women only if the benefit outweighs the risk.

Cefuroxime has been shown to cross the placenta and attain therapeutic levels in amniotic fluid and cord blood after intramuscular or intravenous dose to the mother.

Nursing mothers

Cefuroxime is excreted in human milk in small quantities. Adverse reactions at therapeutic doses are not expected, although a risk of diarrhoea and fungus infection of the mucous membranes cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from cefuroxime therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Carcinogenesis, mutagenesis and fertility

Fertility

There are no data on the effects of cefuroxime axetil on fertility in humans. Reproductive studies in animals have shown no effects on fertility.

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, as this medicine may cause dizziness, patients should be warned to be cautious when driving or operating machinery.

Adverse reactions


Oral administration

The most common adverse reactions are Candida overgrowth, eosinophilia, headache, dizziness, gastrointestinal disturbances and transient rise in liver enzymes.

The frequency categories assigned to the adverse reactions below are estimates, as for most reactions suitable data (for example from placebo-controlled studies) for calculating incidence were not available. In addition the incidence of adverse reactions associated with cefuroxime axetil may vary according to the indication.

Data from large clinical studies were used to determine the frequency of very common to rare undesirable effects. The frequencies assigned to all other undesirable effects (i.e. those occurring at <1/10,000) were mainly determined using post-marketing data and refer to a reporting rate rather than true frequency. Placebo-controlled trial data were not available. Where incidences have been calculated from clinical trial data, these were based on drug-related (investigator assessed) data. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Treatment related adverse reactions, all grades, are listed below by MedDRA body system organ class, frequency and grade of severity. The following convention has been utilised for the classification of frequency: very common ≥1/10; common ≥1/100 to <1/10, uncommon ≥1/1,000 to <1/100; rare ≥1/10,000 to <1/1,000; very rare <1/10,000 and not known (cannot be estimated from the available data).

Infections and infestations

Common: Candida overgrowth

Not known: Clostridium difficile overgrowth

Blood and lymphatic system disorders

Common: eosinophilia

Uncommon: positive Coomb’s test, thrombocytopenia, leukopenia (sometimes profound)

Not known: haemolytic anaemia

Immune system disorders

Not known: drug fever, serum sickness, anaphylaxis, Jarisch-Herxheimer reaction

Nervous system disorders

Common: headache, dizziness

Gastrointestinal disorders

Common: diarrhoea, nausea, abdominal pain

Uncommon: vomiting

Not known: pseudomembranous colitis

Hepatobiliary disorders

Common: transient increases of hepatic enzyme levels

Not known: jaundice (predominantly cholestatic), hepatitis

Skin and subcutaneous tissue disorders

Uncommon: skin rashes

Not known: urticaria, pruritus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthematic necrolysis) (see Immune system disorders), angioneurotic oedema

Description of selected adverse reactions

Cephalosporins as a class tend to be absorbed onto the surface of red cells membranes and react with antibodies directed against the drug to produce a positive Coombs test (which can interfere with cross-matching of blood) and very rarely haemolytic anaemia.

Transient rises in serum liver enzymes have been observed which are usually reversible.

Paediatric population

The safety profile for cefuroxime axetil in children is consistent with the profile in adults.

IV/IM administration

The most common adverse reactions are neutropenia, eosinophilia, transient rise in liver enzymes or bilirubin, particularly in patients with pre-existing liver disease, but there is no evidence of harm to the liver and injection site reactions.

The frequency categories assigned to the adverse reactions below are estimates, as for most reactions suitable data for calculating incidence are not available. In addition the incidence of adverse reactions associated with cefuroxime sodium may vary according to the indication.

Data from clinical trials were used to determine the frequency of very common to rare adverse reactions. The frequencies assigned to all other adverse reactions (i.e. those occurring at <1/10,000) were mainly determined using post-marketing data, and refer to a reporting rate rather than a true frequency.

Treatment related adverse reactions, all grades, are listed below by MedDRA body system organ class, frequency and grade of severity. The following convention has been utilised for the classification of frequency: very common ≥1/10; common ≥1/100 to <1/10; uncommon ≥1/1,000 to <1/100; rare ≥1/10,000 to <1/1,000; very rare <1/10,000 and not known (cannot be estimated from the available data).

Infections and infestations

Not known: Candida overgrowth, overgrowth of Clostridium difficile

Blood and lymphatic system disorders

Common: neutropenia, eosinophilia, decreased haemoglobin concentration

Uncommon: leukopenia, positive Coombs test

Not known: thrombocytopenia, haemolytic anaemia

Immune system disorders

Not known: drug fever, interstitial nephritis, anaphylaxis, cutaneous vasculitis

Gastrointestinal disorders

Uncommon: gastrointestinal disturbance

Not known: pseudomembranous colitis

Hepatobiliary disorders

Common: transient rise in liver enzymes

Uncommon: transient rise in bilirubin

Skin and subcutaneous tissue disorders

Uncommon: skin rash, urticaria and pruritus

Not known: erythema multiforme, toxic epidermal necrolysis and Stevens-Johnson syndrome, angioneurotic oedema

Renal and urinary disorders

Not known: elevations in serum creatinine, elevations in blood urea nitrogen and decreased creatinine clearance

General disorders and administration site conditions

Common: injection site reactions which may include pain and thrombophlebitis

Description of selected adverse reactions

Cephalosporins as a class tend to be absorbed onto the surface of red cell membranes and react with antibodies directed against the drug to produce a positive Coombs test (which can interfere with cross matching of blood) and very rarely haemolytic anaemia.

Transient rises in serum liver enzymes or bilirubin have been observed which are usually reversible.

Pain at the intramuscular injection site is more likely at higher doses. However it is unlikely to be a cause for discontinuation of treatment.

Paediatric population

The safety profile for cefuroxime sodium in children is consistent with the profile in adults.

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Review your medication to ensure that there are no potentially harmful drug interactions or contraindications.

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