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:

Organon LLC

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, RediTabs, and Oral Solution are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine [see Warnings and Precautions (5.1) and Adverse Reactions (6.2)]. Risk Summary The limited available data with CLARINEX in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are no adequate and well-controlled studies in pregnant women. Desloratadine given during organogenesis to pregnant rats was not teratogenic at the

Product summary:

CLARINEX Tablets: Storage

Authorization status:

New Drug Application

Summary of Product characteristics

CLARINEX- DESLORATADINE TABLET, FILM COATED
ORGANON LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLARINEX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLARINEX.
CLARINEX (DESLORATADINE) TABLETS, REDITABS
, AND ORAL SOLUTION FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
CLARINEX IS A HISTAMINE-1 (H1) 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)
DOSAGE AND ADMINISTRATION
DOSAGE (BY AGE):
ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OVER:
CLARINEX Tablets - one 5 mg tablet once daily OR
CLARINEX RediTabs Tablets - one 5 mg tablet once daily OR
CLARINEX Oral Solution - 2 teaspoonfuls (5 mg in 10 mL) once daily (2)
CHILDREN 6 TO 11 YEARS OF AGE:
CLARINEX Oral Solution - 1 teaspoonful (2.5 mg in 5 mL) once daily OR
CLARINEX RediTabs Tablets - one 2.5 mg tablet once daily (2)
CHILDREN 12 MONTHS TO 5 YEARS OF AGE:
CLARINEX Oral Solution - ½ teaspoonful (1.25 mg in 2.5 mL) once daily
(2)
CHILDREN 6 TO 11 MONTHS OF AGE:
CLARINEX Oral Solution - 2 mL (1 mg) once daily (2)
DOSAGE FORMS AND STRENGTHS
CLARINEX Tablets - 5 mg (3)
CONTRAINDICATIONS
Hypersensitivity (4, 6.2)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions including rash, pruritus, urticaria, edema,
dyspnea, and anaphylaxis have
been reported. In such cases, stop CLARINEX at once and consider
alternative treatments. (5.1)
ADVERSE REACTIONS
The most common adverse reactions (reported in ≥2% of adult and
adolescent patients with allergic
rhinitis and greater than placebo) were pharyngitis, dry mouth,
myalgia, fatigue, somnolence,
dysmenorrhea. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CO