País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
DESLORATADINE (UNII: FVF865388R) (DESLORATADINE - UNII:FVF865388R)
Physicians Total Care, Inc.
DESLORATADINE
DESLORATADINE 5 mg
ORAL
PRESCRIPTION DRUG
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. 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. 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. CLARINEX Tablets 5 mg are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients, or to loratadine. There is no information to indicate that abuse or dependency occurs with CLARINEX Tablets.
Embossed "C5", light blue film coated tablets; that are packaged in Protect Unit-of-Use packaging 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). Rev. 2/07 23882191T 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. Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK 74146
New Drug Application
CLARINEX - DESLORATIDINE TABLET, FILM COATED PHYSICIANS TOTAL CARE, INC. ---------- DESCRIPTION CLARINEX (desloratadine) Tablets are light blue, round, film coated tablets containing 5 mg desloratadine, an antihistamine, to be administered orally. It also contains the following excipients: dibasic calcium phosphate dihydrate USP, microcrystalline cellulose NF, corn starch NF, talc USP, carnauba wax NF, white wax NF, coating material consisting of lactose monohydrate, hypromellose, titanium dioxide, polyethylene glycol, and FD&C Blue #2 Aluminum Lake. CLARINEX Syrup is a clear orange colored liquid containing 0.5 mg/1 mL desloratadine. The syrup contains the following inactive ingredients: propylene glycol USP, sorbitol solution USP, citric acid (anhydrous) USP, sodium citrate dihydrate USP, sodium benzoate NF, disodium edetate USP, purified water USP. It also contains granulated sugar, natural and artificial flavor for bubble gum and FD&C Yellow #6 dye. The CLARINEX RediTabs brand of desloratadine orally-disintegrating tablets are 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. Each RediTabs Tablet contains either 5 mg or 2.5 mg of desloratadine. It also contains the following inactive ingredients: mannitol USP, microcrystalline cellulose NF, pregelatinized starch, NF, sodium starch glycolate, NF, magnesium stearate NF, butylated methacrylate copolymer, crospovidone, NF, aspartame NF, citric acid USP, sodium bicarbonate USP, colloidal silicon dioxide, NF, ferric oxide red NF and tutti frutti flavoring. Desloratadine is a white to off-white powder that is slightly soluble in water, but very soluble in ethanol and propylene glycol. It has an empirical formula: C H ClN and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5_H_- benzo[5,6]cyclohepta[1,2-_b_]pyridine and has the following structure: CLINICAL PHARMACOLOGY Mechanism of Action Desloratadine is a long-ac Leer el documento completo