Accolate

Indications & Dosage

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INDICATIONS

ACCOLATE 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, 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 5through 11 years of age is 10 mg twice daily.

Elderly Patients: Based on cross-study comparisons, the clearance of zafirlukast is reduced in elderly patients (65 years of age and older), such that C_max and AUC areapproximately 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 C_max 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.

HOW SUPPLIED

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 and Hospital Unit Dose blister packages of 100 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 and Hospital Unit Dose blister packages of 100 tablets.

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.

ACCOLATE is a trademark of the AstraZeneca group of companies.
Ò AstraZeneca 2001, 2004

Manufactured for:
AstraZeneca Pharmaceuticals LP., Wilmington,DE 19850
By: IPR Pharmaceuticals, Inc. Carolina, PR 00984
FDA rev date: 06/06/05

Brand Name: Accolate
Generic Name: Zafirlukast

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