CLARINEX- desloratadine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Desloratadine (UNII: FVF865388R) (Desloratadine - UNII:FVF865388R)

Available from:

Rebel Distributors Corp

INN (International Name):

Desloratadine

Composition:

Desloratadine 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Embossed "C5", light blue film coated tablets; that are packaged in high-density polyethylene plastic bottles of 10 (NDC 21695-815-10). 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).

Authorization status:

New Drug Application

Summary of Product characteristics

CLARINEX- DESLORATADINE TABLET, FILM COATED
REBEL DISTRIBUTORS CORP
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CLARINEX (DESLORATADINE) TABLETS
PRODUCT INFORMATION
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 FDC
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