Chemical formula: C₁₆H₁₆N₄O₈S Molecular mass: 424.385 g/mol PubChem compound: 5479529
Cefuroxime interacts in the following cases:
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 clearance | T1/2(hrs) | Dose (mg) |
|---|---|---|
| >20 mL/min/1.73 m² | 1.7–2.6 | It is not necessary to reduce the standard dose (750 mg to 1.5 g three times daily). |
| 10-20 mL/min/1.73 m² | 4.3–6.5 | 750 mg twice daily |
| <10 mL/min/1.73 m² | 14.8–22.3 | 750 mg once daily |
| Patients on haemodialysis | 3.75 | A 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 units | 7.9–12.6 (CAVH). 1.6 (HF) | 750 mg twice daily; for low-flux haemofiltration follow the dosage recommended under impaired renal function. |
Concomitant use with oral anticoagulants may give rise to increased international normalised ratio (INR).
Cefuroxime may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
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.
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.
The development of a positive Coombs Test associated with the use of cefuroxime may interfere with cross matching of blood.
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.
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.
There are no data on the effects of cefuroxime axetil on fertility in humans. Reproductive studies in animals have shown no effects on fertility.
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.
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).
Common: Candida overgrowth
Not known: Clostridium difficile overgrowth
Common: eosinophilia
Uncommon: positive Coomb’s test, thrombocytopenia, leukopenia (sometimes profound)
Not known: haemolytic anaemia
Not known: drug fever, serum sickness, anaphylaxis, Jarisch-Herxheimer reaction
Common: headache, dizziness
Common: diarrhoea, nausea, abdominal pain
Uncommon: vomiting
Not known: pseudomembranous colitis
Common: transient increases of hepatic enzyme levels
Not known: jaundice (predominantly cholestatic), hepatitis
Uncommon: skin rashes
Not known: urticaria, pruritus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthematic necrolysis) (see Immune system disorders), angioneurotic oedema
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.
The safety profile for cefuroxime axetil in children is consistent with the profile in adults.
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).
Not known: Candida overgrowth, overgrowth of Clostridium difficile
Common: neutropenia, eosinophilia, decreased haemoglobin concentration
Uncommon: leukopenia, positive Coombs test
Not known: thrombocytopenia, haemolytic anaemia
Not known: drug fever, interstitial nephritis, anaphylaxis, cutaneous vasculitis
Uncommon: gastrointestinal disturbance
Not known: pseudomembranous colitis
Common: transient rise in liver enzymes
Uncommon: transient rise in bilirubin
Uncommon: skin rash, urticaria and pruritus
Not known: erythema multiforme, toxic epidermal necrolysis and Stevens-Johnson syndrome, angioneurotic oedema
Not known: elevations in serum creatinine, elevations in blood urea nitrogen and decreased creatinine clearance
Common: injection site reactions which may include pain and thrombophlebitis
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.
The safety profile for cefuroxime sodium in children is consistent with the profile in adults.
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