Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
DESLORATADINE (UNII: FVF865388R) (DESLORATADINE - UNII:FVF865388R)
Organon LLC
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, 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
CLARINEX Tablets: Storage
New Drug Application
CLARINEX- DESLORATADINE TABLET, FILM COATED ORGANON LLC ---------- 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 Прочетете целия документ