Clarinex (Desloratadine) - Indications and Dosage

INDICATIONS AND USAGE

Seasonal Allergic Rhinitis

CLARINEX is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 2 years of age and older.

Perennial Allergic Rhinitis

CLARINEX is indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 6 months of age and older.

Chronic Idiopathic Urticaria

CLARINEX is indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 6 months of age and older.

DOSAGE AND ADMINISTRATION

Adults and children 12 years of age and over

The recommended dose of CLARINEX Tablets or CLARINEX RediTabs Tablets is one 5 mg tablet once daily or the recommended dose of CLARINEX Syrup is 2 teaspoonfuls (5 mg in 10 mL) once daily.

Children 6 to 11 years of age

The recommended dose of CLARINEX Syrup is 1 teaspoonful (2.5 mg in 5 mL) once daily or the recommended dose of CLARINEX RediTabs Tablets is one 2.5 mg tablet once daily.

Children 12 months to 5 years of age

The recommended dose of CLARINEX Syrup is ½ teaspoonful (1.25 mg in 2.5 mL) once daily.

Children 6 to 11 months of age

The recommended dose of CLARINEX Syrup is 2 mL (1.0 mg) once daily.

The age-appropriate dose of CLARINEX Syrup should be administered with a commercially available measuring dropper or syringe that is calibrated to deliver 2 mL and 2.5 mL (½ teaspoon).

In adult patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data.

Administration of CLARINEX RediTabs Tablets

Place CLARINEX (desloratadine) RediTabs Tablets on the tongue and allow to disintegrate before swallowing. Tablet disintegration occurs rapidly. Administer with or without water. Take tablet immediately after opening the blister.

HOW SUPPLIED

CLARINEX Tablets

Embossed "C5", light blue film coated tablets; that are packaged in high-density polyethylene plastic bottles of 100 (NDC 0085-1264-01) and 500 (NDC 0085-1264-02). Also available, CLARINEX Unit-of-Use package of 30 tablets (3 × 10; 10 blisters per card) (NDC 0085-1264-04); and Unit Dose-Hospital Pack of 100 Tablets (10 × 10; 10 blisters per card) (NDC 0085-1264-03).

Protect Unit-of-Use packaging and Unit Dose-Hospital Pack from excessive moisture.

Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature]. Heat sensitive. Avoid exposure at or above 30°C (86°F).

CLARINEX Syrup

Clear orange colored liquid containing 0.5 mg/1 mL desloratadine in a 16-ounce Amber glass bottle (NDC 0085-1334-01) and a 4-ounce Amber glass bottle (NDC 0085-1334-02).

Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature]. Protect from light.

CLARINEX REDITABS (desloratadine orally-disintegrating tablets)

2.5 mg and 5 mg: Light-red, flat-faced, round, speckled tablets with an "A" debossed on one side for the 5 mg tablets and a "K" debossed on one side for the 2.5 mg tablets. One tablet per cavity in peel off foil/foil blisters. Packs of 30 tablets (containing 5 × 6's) 5 mg - NDC 0085-1384-01 and 2.5 mg - NDC 0085-1408-01.

Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].

Rev. 2/07
23882191T

CLARINEX REDITABS brand of desloratadine orally-disintegrating tablets are manufactured for Schering Corporation by CIMA LABS INC.^®, Eden Prairie, MN 55344 USA.

U.S. Patent Nos. 4,659,716; 4,863,931; 5,178,878; 5,607,697; 6,100,274; 6,514,520; 6,709,676; and 6,979,463.

Copyright © 2004, 2005, Schering Corporation. All rights reserved.