A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Clarinex Indications, Dosage, Storage, Stability - Desloratadine
Clarinex Indications, Dosage, Storage, Stability - Desloratadine
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.
Children 12 months to 5 years of age The recommended
dose of CLARINEX Syrup is 1/2 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 (1/2 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.
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 x 10; 10 blisters per card) (NDC 0085-1264-04); and Unit Dose-Hospital
Pack of 100 Tablets (10 x 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/1mL desloratadine in a 16-ounce Amber glass bottle (NDC 0085-1334-01).
Store syrup at 25°C (77°F); excursions permitted between 15-
30°C (59-86°F) [see USP Controlled Room Temperature] Protect from light.
CLARINEX REDITABS (desloratadine orally-disintegrating tablets)
5 mg: "C" debossed, pink tablets in foil/foil blisters. Packs
of 30 tablets (containing 3 x 10’s) NDC 0085-1280-01.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
[see USP Controlled Room Temperature]
Schering Corporation Kenilworth, NJ 07033 USA,
Rev. 8/04, 23882167T, CLARINEX REDITABS brand of desloratadine orally-disintegrating
tablets are manufactured for Schering Corporation by Cardinal Health UK. 416
Limited, England. U.S. Patent Nos. 4,659,716; 4,804,666; 4,863,931; 5,595,997;
and 6,100,274 Copyright © 2004, Schering Corporation. All rights reserved.
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