What is Zafirlukast and how is it used?
Zafirlukast is a prescription medicine used to treat the symptoms of Asthma. Zafirlukast may be used alone or with other medications.
Zafirlukast belongs to a class of drugs called Leukotriene Receptor Antagonists.
It is not known if Zafirlukast is safe and effective in children younger than 5 years of age.
ZAFIRLUKAST is indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.
DOSAGE AND ADMINISTRATION
Because food can reduce the bioavailability of zafirlukast, ZAFIRLUKAST should be taken at least 1 hour before or 2 hours after meals.
Adults and Children 12 years of age and older
The recommended dose of ZAFIRLUKAST in adults and children 12 years and older is 20 mg twice daily.
Pediatric Patients 5 through 11 years of age
The recommended dose of ZAFIRLUKAST in children 5 through 11 years of age is 10 mg twice daily.
Based on cross-study comparisons, the clearance of zafirlukast is reduced in elderly patients (65 years of age and older), such that Cmax and AUC are approximately twice those of younger adults. In clinical trials, a dose of 20 mg twice daily was not associated with an increase in the overall incidence of adverse events or withdrawals because of adverse events in elderly patients.
Patients with Hepatic Impairment
ZAFIRLUKAST is contraindicated in patients with hepatic impairment including hepatic cirrhosis (see CONTRAINDICATIONS). The clearance of zafirlukast is reduced in patients with stable alcoholic cirrhosis such that the Cmax and AUC are approximately 50 – 60% greater than those of normal adults. ZAFIRLUKAST has not been evaluated in patients with hepatitis or in long-term studies of patients with cirrhosis.
Patients with Renal Impairment
Dosage adjustment is not required for patients with renal impairment.
Store at controlled room temperature, 20-25°C (68-77°F) [see USP]. Protect from light and moisture. Dispense in the original air-tight container.