CLARINEX- desloratidine tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

DESLORATADINE (UNII: FVF865388R) (DESLORATADINE - UNII:FVF865388R)

Boleh didapati daripada:

Physicians Total Care, Inc.

INN (Nama Antarabangsa):

DESLORATADINE

Komposisi:

DESLORATADINE 5 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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.

Ringkasan produk:

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

Status kebenaran:

New Drug Application

Ciri produk

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