Composition: Zanamivir 5mg, delivering an inhalation dose of zanamivir 3.6mg.
Presentation: Inhalation powder pre-dispensed into four blisters on a circular aluminium foil disk (Rotadisk). An inspiration driven Diskhaler is used for administration of doses.
Storage and stability: Do not store above 30C.
Action: Selective inhibitor of neuraminidase, the influenza virus surface enzyme. It reduces the propagation of both influenza A and B viruses by inhibiting the release of infectious influenza virions from the epithelial cells of the respiratory tract.
Indications: Treatment of both influenza A and B in adults and adolescents Ž 12 years who present with the symptoms typical of influenza when influenza is circulating in the community.
Contraindications: Hypersensitivity to any ingredient.
Dosage and administration: Treatment should begin as soon as possible within 48 hours after onset of symptoms. Administer by oral inhalation only, using the Diskhaler device provided. The recommended dose is two inhalations (2 x 5mg blisters) twice daily for five days. Inhaled drugs, eg, asthma medication, should be taken prior to administration of zanamivir.
Pregnancy and lactation, zanamivir should not be used in pregnancy unless the expected benefit to the mother is thought to outweigh any possible risk to the foetus. Use during breastfeeding is not recommended.
Overdosage: Doses approximately three times the maximum daily recommended dose (20mg) have been administered by oral inhalation without adverse effects. Intravenous administration of up to 1,200mg/day for five days showed no adverse effect.
Precautions: Efficacy and safety have not been assessed in children. Effectiveness of zanamivir in elderly patients, patients with asthma or other chronic respiratory diseases, unstable chronic illnesses or immunocompromised patients has not been demonstrated.
Drug interactions: Clinically significant drug interactions are unlikely.
Side effects: The nature of the most frequently reported adverse events, such as nasal signs and symptoms, headache, gastrointestinal symptoms, bronchitis and cough, are typical of the signs and symptoms of influenza.
Net price: Diskhaler with five disks (each containing 4 x 5mg blisters) £24.
Supplier: Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge, Middlesex UB11 1BT. Tel 020 89909000, fax 020 89904321.
Legal class: POM.