ACCOLATE (Page 4 of 4)

Pediatric Patients 5 through 11 years of age

ACCOLATE has been evaluated for safety in 788 pediatric patients 5 through 11 years of age. Cumulatively, 313 pediatric patients were treated with ACCOLATE 10 mg twice daily or higher for at least 6 months, and 113 of them were treated for one year or longer in clinical trials. The safety profile of ACCOLATE 10 mg twice daily-versus placebo in the 4- and 6-week double-blind trials was generally similar to that observed in the adult clinical trials with ACCOLATE 20 mg twice daily.

In pediatric patients receiving ACCOLATE in multi-dose clinical trials, the following events occurred with a frequency of ≥ 2% and more frequently than in pediatric patients who received placebo, regardless of causality assessment: headache (4.5 vs. 4.2%) and abdominal pain (2.8 vs. 2.3%).

The post-marketing experience in this age group is similar to that seen in adults, including hepatic dysfunction, which may lead to liver failure.

OVERDOSAGE

No deaths occurred at oral zafirlukast doses of 2000 mg/kg in mice (approximately 210 times the maximum recommended daily oral dose in adults and children on a mg/m² basis), 2000 mg/kg in rats (approximately 420 times the maximum recommended daily oral dose in adults and children on a mg/m² basis), and 500 mg/kg in dogs (approximately 350 times the maximum recommended daily oral dose in adults and children on a mg/m² basis).

Overdosage with ACCOLATE has been reported in four patients surviving reported doses as high as 200 mg. The predominant symptoms reported following ACCOLATE overdose were rash and upset stomach. There were no acute toxic effects in humans that could be consistently ascribed to the administration of ACCOLATE. It is reasonable to employ the usual supportive measures in the event of an overdose; eg, remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

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 C_max 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 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, white, unflavored, round, biconvex, film-coated, mini-tablets identified with “ACCOLATE 10” debossed on one side.

ACCOLATE 20 mg Tablets, white, round, biconvex, coated tablets identified with “ACCOLATE 20” debossed on one side are supplied.

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC	Strength	Quantity/Form	Color	Source Prod. Code
53808-0203-1	20 mg	30 Tablets in a Blister Pack	WHITE	0310-0402

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.

^© AstraZeneca 2001, 2004, 2007, 2009

Manufactured for:

AstraZeneca Pharmaceuticals LP

Wilmington, DE 19850

By: IPR Pharmaceuticals, Inc.

Canovanas, PR 00729

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACCOLATE zafirlukast tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-0203(NDC:0310-0402) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZAFIRLUKAST (ZAFIRLUKAST) ZAFIRLUKAST 20 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE TITANIUM DIOXIDE HYPROMELLOSE

Product Characteristics Color WHITE Score no score Shape ROUND (biconvex) Size 8mm Flavor Imprint Code ACCOLATE20 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:53808-0203-1 30 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020547 07/01/2009

Labeler — State of Florida DOH Central Pharmacy (829348114)

Establishment
Name	Address	ID/FEI	Operations
State of Florida DOH Central Pharmacy		829348114	repack

Revised: 05/2010 State of Florida DOH Central Pharmacy