Children under 7 years of age: There is no clinical experience of the use of Zafirlukast in children under 7 years of age until safety information is available.
Children over 7 years through 11 years of age: The recommended dose of Zafirlukast in this age group is 10 mg twice daily.
Adult and children aged 12 years and over: The dosage is one 20 mg tablet twice daily. This dosage should not be exceeded. Higher doses may be associated with elevations of one or more liver enzymes consistent with hepatotoxicity. As food may reduce the bioavailability of Zafirlukast, Zafirlukast should not be taken with meals
Elderly: The clearance of Zafirlukast is significantly reduced in elderly patients (over 65 years old), and Cmax and AUC are approximately double than those of younger adults. However, accumulation of Zafirlukast is not greater than that seen in multiple dose trials conducted in adult subjects with asthma and the consequences of the altered kinetic in the elderly are unknown. Clinical experience with Zafirlukast in the elderly (over 65 years) is limited and caution is recommended until further information is available.
Side Effects:Systemic eosinophilia, eosinophilic pneumonia or with clinical features of systemic vasculitis consistent with Churg-Strauss syndrome; neuropsychiatric adverse events (e.g. insomnia, depression); headache, resp tract infection, GI disturbances, arthralgia, myalgia, fever, malaise, insomnia, dizziness, elevated liver enzyme values, hypersensitivity reactions (e.g. rashes, pruritus, urticaria, angioedema), agranulocytosis, bleeding, bruising, oedema.
Store between 20-25° C. Protect from light and moisture.