Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Cefuroxime axetil is indicated for the treatment of the infections listed below in adults and children from the age of 3 months (see sections 4.4 and 5.1):
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The usual course of therapy is seven days (may range from five to ten days).
Table 1. Adults and children (≥40 kg):
| Indication | Dosage |
|---|---|
| Acute tonsillitis and pharyngitis, acute bacterial sinusitis | 250 mg twice daily |
| Acute otitis media | 500 mg twice daily |
| Acute exacerbations of chronic bronchitis | 500 mg twice daily |
| Cystitis | 250 mg twice daily |
| Pyelonephritis | 250 mg twice daily |
| Uncomplicated skin and soft tissue infections | 250 mg twice daily |
| Lyme disease | 500 mg twice daily for 14 days (range of 10 to 21 days) |
Table 2. Children (<40 kg):
| Indication | Dosage |
|---|---|
| Acute tonsillitis and pharyngitis, acute bacterial sinusitis | 10 mg/kg twice daily to a maximum of 125 mg twice daily |
| Children aged two years or older with otitis media or, where appropriate, with more severe infections | 15 mg/kg twice daily to a maximum of 250 mg twice daily |
| Cystitis | 15 mg/kg twice daily to a maximum of 250 mg twice daily |
| Pyelonephritis | 15 mg/kg twice daily to a maximum of 250 mg twice daily for 10 to 14 days |
| Uncomplicated skin and soft tissue infections | 15 mg/kg twice daily to a maximum of 250 mg twice daily |
| Lyme disease | 15 mg/kg twice daily to a maximum of 250 mg twice daily for 14 days (10 to 21 days) |
There is no experience of using cefuroxime axetil in children under the age of 3 months.
The safety and efficacy of cefuroxime axetil in patients with renal failure have not been established.
Cefuroxime is primarily excreted by the kidneys. In patients with markedly impaired renal function it is recommended that the dosage of cefuroxime should be reduced to compensate for its slower excretion. Cefuroxime is effectively removed by dialysis.
Recommended doses for Axetine in renal impairment:
| Creatinine clearance | T1/2 (hrs) | Recommended dosage |
|---|---|---|
| ≥30 mL/min/1.73 m² | 1.4–2.4 | no dose adjustment necessary (standard dose of 125 mg to 500 mg given twice daily) |
| 10-29 mL/min/1.73 m² | 4.6 | standard individual dose given every 24 hours |
| <10 mL/min/1.73 m² | 16.8 | standard individual dose given every 48 hours |
| Patients on haemodialysis | 2–4 | a further standard individual dose should be given at the end of each dialysis |
There are no data available for patients with hepatic impairment. Since cefuroxime is primarily eliminated by the kidney, the presence of hepatic dysfunction is expected to have no effect on the pharmacokinetics of cefuroxime.
Oral use.
Axetine tablets should be taken after food for optimum absorption.
Axetine tablets should not be crushed and are therefore unsuitable for treatment of patients who cannot swallow tablets. Other formulations with cefuroxime axetil may be used in children.
Overdose can lead to neurological sequelae including encephalopathy, convulsions and coma. Symptoms of overdose can occur if the dose is not reduced appropriately in patients with renal impairment (see sections 4.2 and 4.4).
Serum levels of cefuroxime can be reduced by haemodialysis and peritoneal dialysis.
36 months.
Store below 30°C, in the original package, in order to protect from light.
Axetine is packed in white opaque PVC/PVDC/Alu blisters, Alu-Alu strips and Alu-Alu blisters. Axetine 500mg film-coated tablets is also available in Alu /Alu blisters.
Available pack sizes are:
Blisters: 10 tablets, 14 tablets, 20 tablets, 30 tablets and 50 tablets.
Not all pack sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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