Drug Catalog - Product Detail
DESLORATADINE ODT TB 5MG 5X6 UD
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 55111-0360-31 | DR.REDDY'S LABORATORIES, INC. | 30 | 5MG | TABLET |
PACKAGE FILES
Generic Name
DESLORATADINE
Substance Name
DESLORATADINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA078367
Description
11 DESCRIPTION The desloratadine orally disintegrating tablets, USP light red colored, speckled, round, flat, uncoated, beveled edged debossed with “R” on one side and “551” on the other side for the 2.5 mg tablets and a “light red colored, speckled, round, flat, uncoated, beveled edged debossed with “RDY” on one side and “360” on the other side for the 5 mg tablets. Each orally disintegrating tablet contains either 5 mg or 2.5 mg of desloratadine. It also contains the following inactive ingredients: anhydrous citric acid, aspartame, colloidal silicon dioxide, crospovidone, ferric oxide, mannitol, lactose anhydrous, microcrystalline cellulose, polacrilex resin, sodium stearyl fumarate, talc, tutti frutti flavor. Desloratadine, USP is a white to light pink colored powder that is soluble in dichloromethane. It has an molecular formula: C 19 H 19 ClN 2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine and has the following structure:
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Desloratadine Orally Disintegrating Tablets USP, 2.5 mg: Desloratadine orally disintegrating tablets USP, tablets 2.5 mg are light red colored, speckled, round, flat, uncoated, beveled edged debossed with “R” on one side and “551” on the other side and are supplied in carton of 5 packs containing 6 tablets each. Carton of 5 packs (NDC 55111-551-31), each pack containing 6 tablets (55111-551-06) Desloratadine Orally Disintegrating Tablets USP, 5 mg: Desloratadine orally disintegrating tablets USP, tablets 5 mg are light red colored, speckled, round, flat, uncoated, beveled edged debossed with “RDY” on one side and “360” on the other side and are supplied in carton of 5 packs containing 6 tablets each. Carton of 5 packs (NDC 55111-360-31), each pack containing 6 tablets (55111-360-06) Storage: Store orally disintegrating tablets at 20°C to 25°C (68°F to 77°F) excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Desloratadine is a histamine-1 (H 1 ) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older. (1.1) Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 6 months of age and older. (1.2) Chronic Idiopathic Urticaria: symptomatic relief of pruritus, reduction in the number of hives, and size of hives in patients 6 months of age and older. ( 1.3 ) 1.1 Seasonal Allergic Rhinitis Desloratadine orally disintegrating tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 2 years of age and older. 1.2 Perennial Allergic Rhinitis Desloratadine orally disintegrating tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 6 months of age and older. 1.3 Chronic Idiopathic Urticaria Desloratadine orally disintegrating tablets are 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
2 DOSAGE AND ADMINISTRATION Desloratadine orally disintegrating tablets may be taken without regard to meals. Place desloratadine orally disintegrating 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. Dosage (by age): Adults and Adolescents 12 Years of Age and Over: Desloratadine orally disintegrating tablets - one 5 mg tablet once daily (2) Children 6 to 11 Years of Age: Desloratadine orally disintegrating tablets - one 2.5 mg tablet once daily (2) 2.1 Adults and Adolescents 12 Years of Age and Over The recommended dose of desloratadine orally disintegrating tablets is one 5 mg tablet once daily. 2.2 Children 6 to 11 Years of Age The recommended dose of desloratadine orally disintegrating tablet is one 2.5 mg tablet once daily. NOTE: Desloratadine orally disintegrating tablets are not recommended for use in pediatric patients under 6 years of age as desloratadine syrup is better suited for these patients. 2.5 Adults with Hepatic or Renal Impairment 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 [see Clinical Pharmacology (12.3) ].