Allegra (Fexofenadine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Seasonal Allergic Rhinitis

ALLEGRA is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older.

Chronic Idiopathic Urticaria

ALLEGRA is indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.

DOSAGE AND ADMINISTRATION

ALLEGRA tablets

Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria

Adults and Children 12 Years and Older. The recommended dose of ALLEGRA tablets is 60 mg twice daily or 180 mg once daily with water. A dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function [see CLINICAL PHARMACOLOGY ).

Children 6 to 11 Years. The recommended dose of ALLEGRA tablets is 30 mg twice daily with water. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function (see CLINICAL PHARMACOLOGY).

ALLEGRA ODT

Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria

Children 6 to 11 Years . ALLEGRA ODT is intended for use only in children 6 to 11 years of age. The recommended dose of ALLEGRA ODT is 30 mg twice daily. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function (see CLINICAL PHARMACOLOGY).

ALLEGRA ODT is designed to disintegrate on the tongue, followed by swallowing with or without water. ALLEGRA ODT should be taken on an empty stomach. ALLEGRA ODT is not intended to be chewed.

ALLEGRA ODT should not be removed from the original blister package until the time of administration.

ALLEGRA oral suspension

HOW SUPPLIED/STORAGE AND HANDLING

ALLEGRA Tablets

ALLEGRA 30 mg tablets are available in: high-density polyethylene (HDPE) bottles of 100 (NDC 0088-1106-47) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal and HDPE bottles of 500 (NDC 0088-1106-55) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal.

ALLEGRA 60 mg tablets are available in: HDPE bottles of 100 (NDC 0088-1107-47) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal; HDPE bottles of 500 (NDC 0088-1107-55) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal; and aluminum foil-backed clear blister packs of 100 (NDC 0088-1107-49).

ALLEGRA 180 mg tablets are available in: HDPE bottles of 100 (NDC 0088-1109-47) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal and HDPE bottles of 500 (NDC 0088-1109-55) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal.

ALLEGRA Tablets are coated with a peach colored film coating. Tablets have the following unique shape and identifiers: 30 mg tablets are round, bi-convex and have 03 on one side and a scripted "e" on the other; 60 mg tablets are oval, bi-convex and have 06 on one side and a scripted "e" on the other; and 180 mg tablets are oblong, bi-convex and have 018 on one side and a scripted "e" on the other.

Store ALLEGRA Tablets at controlled room temperature 20–25°C (68–77°F). (See USP Controlled Room Temperature). Foil-backed blister packs containing ALLEGRA Tablets should be protected from excessive moisture.

ALLEGRA ODT

ALLEGRA ODT 30 mg Orally Disintegrating Tablets are available in aluminum-foil blister packs of 60 (NDC 0088-1113-30).

Each ALLEGRA ODT is white, flat-faced, ½-inch round shaped with beveled edges and debossed with a scripted "e" on one side and "311AV" on the other side.

Store ALLEGRA ODT at controlled room temperature 20–25°C (68–77°F). (See USP Controlled Room Temperature). Foil-backed blister packs containing ALLEGRA ODT should be protected from moisture. ALLEGRA ODT should not be removed from the original blister package until the time of administration.

ALLEGRA Oral Suspension

ALLEGRA Oral Suspension (fexofenadine hydrochloride, 30 mg/5mL (6 mg/mL)) is available in amber PET bottles containing 30 mL (NDC 0088-1097-10) and 300 mL (NDC 0088-1097-20) of suspension.

Store ALLEGRA Oral Suspension at controlled room temperature 20–25°C (68–77°F). (See USP Controlled Room Temperature).

Shake bottle well, before each use.

PATIENT COUNSELING INFORMATION

Patients and parents/caregivers of pediatric patients taking ALLEGRA Tablets, ALLEGRA ODT or ALLEGRA Oral Suspension should receive the following information:

ALLEGRA Tablets, ALLEGRA ODT or ALLEGRA Oral Suspension are prescribed for the relief of symptoms of seasonal allergic rhinitis or for the relief of symptoms of chronic idiopathic urticaria (hives). Patients should be instructed to take ALLEGRA only as prescribed. Do not exceed the recommended dose. If any untoward effects occur while taking ALLEGRA discontinue use and consult a doctor.

The products should not be used by patients who are hypersensitive to any of the ingredients.

These products should be used in pregnancy or lactation only if the potential benefit justifies the potential risk to the fetus or nursing infant.

Patients and parents/caregivers of pediatric patients should also be advised to store the medication in a tightly closed container in a cool, dry place, away from small children.

For ALLEGRA Tablets: Patients should be advised to take the ALLEGRA Tablets with water.

For ALLEGRA ODT: For ALLEGRA ODT, patients should be advised to take their dose on an empty stomach. ALLEGRA ODT should be allowed to disintegrate on the tongue, followed by swallowing with or without water. ALLEGRA ODT is not intended to be chewed. ALLEGRA ODT should be stored in its original blister package. ALLEGRA ODT should not be removed from the original blister package until the time of administration.

Phenylketonurics: ALLEGRA ODT contains phenylalanine, a component of aspartame. Each 30-mg ALLEGRA ODT contains 5.3 mg phenylalanine. ALLEGRA products other than ALLEGRA ODT do not contain phenylalanine.

For ALLEGRA Oral Suspension: Patients and parents/caregivers of pediatric patients should be advised to shake the ALLEGRA Oral Suspension bottle well, before each use.