国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
Desloratadine (UNII: FVF865388R) (Desloratadine - UNII:FVF865388R)
Dr. Reddy's Laboratories Limited
Desloratadine
Desloratadine 2.5 mg
ORAL
PRESCRIPTION DRUG
Desloratadine orally disintegrating tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 2 years of age and older. Desloratadine orally disintegrating tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 6 months of age and older. Desloratadine orally disintegrating tablets 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 desloratadine 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 summed area under the concentration-time curve (AUC)-based exposures of desloratadine and its metabo
Desloratadine Orally Disintegrating Tablets 2.5 mg: Desloratadine tablets 2.5 mg are light red colored, speckled, round, flat, uncoated, beveled edged debossed with “R” on one side and “551” on the other side and are supplied in carton of 5 packs containing 6 tablets each. Carton of 5 packs (NDC 55111-551-31), each pack containing 6 tablets (55111-551-06) Desloratadine Orally Disintegrating Tablets 5 mg: Desloratadine tablets 5 mg are light red colored, speckled, round, flat, uncoated, beveled edged debossed with “RDY” on one side and “360” on the other side and are supplied in carton of 5 packs containing 6 tablets each. Carton of 5 packs (NDC 55111-360-31), each pack containing 6 tablets (55111-360-06) Storage: Store orally disintegrating tablets at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
DESLORATADINE- DESLORATADINE TABLET, ORALLY DISINTEGRATING DR. REDDY'S LABORATORIES LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DESLORATADINE ORALLY DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DESLORATADINE ORALLY DISINTEGRATING TABLETS DESLORATADINE ORALLY DISINTEGRATING TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2001 INDICATIONS AND USAGE DESLORATADINE 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) DOSAGE AND ADMINISTRATION DOSAGE (BY AGE): ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OVER: Desloratadine orally disintegrating tablets - one 5 mg tablet once daily (2) CHILDREN 6 TO 11 YEARS OF AGE: Desloratadine orally disintegrating tablets - one 2.5 mg tablet once daily (2) DOSAGE FORMS AND STRENGTHS Desloratadine orally-disintegrating tablets - 5 mg (3) Desloratadine orally-disintegrating tablets - 2.5 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 desloratadine 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, CONTACT DR. REDDY’S LABORATORIES INC., AT 1-888-375-3784 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. USE IN SPECIFIC POPULATIONS Renal impairment: dosage adjustment is recommended (2.5, 8.6, 12.3) Hepatic impairment: dosage adjustment is recommended (2.5, 8.7, 12.3) SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPRO 阅读完整的文件