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DOSAGE AND ADMINISTRATION
Because food can reduce the bioavailability of zafirlukast, ACCOLATE 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 ACCOLATE 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 ACCOLATE 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
ACCOLATE 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. ACCOLATE 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.
ACCOLATE 10 mg Tablets, (NDC 0310-0401) white, unflavored, round, biconvex, film-coated, mini-tablets identified with “ACCOLATE 10” debossed on one side are supplied in opaque HDPE bottles of 60 tablets.
ACCOLATE 20 mg Tablets, (NDC 0310-0402) white, round, biconvex, coated tablets identified with “ACCOLATE 20” debossed on one side are supplied in opaque HDPE bottles of 60 tablets.
Store at controlled room temperature, 20-25°C (6877°F) [see USP]. Protect from light and moisture. Dispense in the original air-tight container.
Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Rev . 02/2011
Last reviewed on RxList: 8/18/2011
This monograph has been modified to include the generic and brand name in many instances.
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