Clinical Pharmacology Details


ZANAMIVIR


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Indications & Dose:

Treatment of both influenza A and B in adults and children (> 5 years). Prophylaxis:  Both influenza A and B in adults and children (> 5 years). :


DOSAGE AND ADMINISTRATION:


Zanamivir is for administration to the respiratory tract by oral inhalation only, using the device provided. Patients scheduled to take inhaled drugs, e.g. fast acting bronchodilators, at the same time as Zanamivir  should be advised to administer that drug prior to administration of Zanamivir.


Adults
Treatment of Influenza: The recommended dose of Zanamivir is two inhalations (2 x 5 mg) twice daily for five days, providing a total daily inhaled dose of 20 mg. For maximum benefit, treatment should begin as soon as possible (preferably within two days) after onset of symptoms.
Prophylaxis: The recommended dose of  is two inhalations (2 x 5 mg) once daily for 10 days, providing a total daily inhaled dose of 10mg. This may be increased up to one month if the period of exposure risk extends beyond 10 days. The full course of prophylaxis therapy should be completed as prescribed. 

Contraindications:

 Hypersensitivity to any ingredient of the preparation


 

Side Effects:

Cautions:

Precautions:

Influenza infection can be associated with increased airways hyperesponsiveness. There have been very rare reports of patients being treated for influenza who have experienced bronchospasm and/or decline in respiratory function after the use of Zanamivir, some of whom did not have any previous history of respiratory disease. Any such patients should discontinue Zanamivir and seek medical evaluation. Patients with underlying respiratory disease should have a fast acting bronchodilator available when taking Zanamivir. Influenza can be associated with a variety of neurological and behavioural symptoms. The events were observed mainly early in the illness and often had an abrupt onset and rapid resolution. The contribution of Zanamivir to these events has not been established. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient. 

Interaction:

Zanamivir is not protein bound and not hepatically metabolised or modified. Clinically significant drug interactions are unlikely. 

Warnings:

Adverse Effects:

Lactations:

The safe use of Zanamivir during pregnancy has not been established. Zanamivir should not be used in pregnancy, especially during the first trimester, unless the possible benefit to the patient is thought to outweigh any possible risk to the foetus. However, there is no information on secretion into breast milk in humans. As experience is limited, the use of Zanamivir in nursing mothers should be considered only if the possible benefit to the mother is thought to outweigh any possible risk to the infant. 

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Very rare: Allergic-type reaction, including facial and oropharyngeal oedema, rash, urticaria, severe skin reactions including Erythema Multiforme, StevensJohnson syndrome, Toxic epidermal necrolysis. 

Patient And Carer Advice: