Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Glaxo Wellcome UK Limited trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Zinnat 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 Zinnat in children under the age of 3 months.
Cefuroxime axetil tablets and cefuroxime axetil granules for oral suspension are not bioequivalent and are not substitutable on a milligram-per-milligram basis (see section 5.2).
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.
Table 5. Recommended doses for Zinnat 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 |
| During haemodialysis | 2–4 | a single additional 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.
Zinnat tablets should be taken after food for optimum absorption.
Zinnat tablets should not be crushed and are therefore unsuitable for treatment of patients who cannot swallow tablets. In children Zinnat oral suspension may be used.
Depending on the dosage, there are other presentations available.
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.
Do not store above 30°C.
Aluminium foil blister pack with an aluminium lid.
Pack size: 6, 10, 12, 14, 16, 20, 24 and 50
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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