A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Accolate Indications, Dosage, Storage, Stability - Zafirlukast
Accolate Indications, Dosage, Storage, Stability - Zafirlukast
INDICATIONS AND USAGE
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 5 through 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 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. 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.
All trademarks are the property of the AstraZeneca group AstraZeneca
2001
Manufactured for: AstraZeneca Pharmaceuticals
LP Wilmington, DE 19850 By: IPR Pharmaceuticals, Inc. Carolina, PR 00984, XXXXX-XX
Rev X/XX
Updated May 15, 2004
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