INDICATIONS
Zafirlukast is indicated for the prophylaxis and chronic
treatment of asthma in adults and children 12 years of
age and older.
DOSAGE AND ADMINISTRATION
The recommended dose of zafirlukast is 20 mg twice daily
in adults and children 12 years and older. Since food
reduces the bioavailability of zafirlukast, zafirlukast
should be taken at least 1 hour before or 2 hours after
meals.
Elderly Patients: 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: 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.
Pediatric Patients: The safety and effectiveness of zafirlukast
in pediatric patients below the age of 12 years have not
been established.
HOW SUPPLIED
20 mg Tablets, white, round, biconvex, coated tablets
identified with “ZENECA” debossed on one side
and “ACCOLATE 20” debossed on the other side.
Store at controlled room temperature, (20°-25°)
(68°-77° F). Protect from light and moisture.
Dispense in the original air-tight container.
PRODUCT LISTING
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