Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
DESLORATADINE (UNII: FVF865388R) (DESLORATADINE - UNII:FVF865388R)
A-S Medication Solutions
ORAL
PRESCRIPTION DRUG
Desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older. Desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 12 years of age and older. Desloratadine 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 metabolite approximately 320 times that at the recommended human daily oral dose (R
Product: 50090-4794 NDC: 50090-4794-1 30 TABLET, FILM COATED in a BOTTLE
Abbreviated New Drug Application
DESLORATADINE- DESLORATADINE TABLET, FILM COATED A-S MEDICATION SOLUTIONS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DESLORATADINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DESLORATADINE TABLETS. DESLORATADINE TABLETS FOR ORAL USE INITIAL U.S. APPROVAL: 2001 INDICATIONS AND USAGE Desloratadine TABLETS ARE HISTAMINE-1 (H1) RECEPTOR ANTAGONIST INDICATED FOR: SEASONAL ALLERGIC RHINITIS: relief of nasal and non-nasal symptoms in patients 12 years of age and older. (1.1) PERENNIAL ALLERGIC RHINITIS: relief of nasal and non-nasal symptoms in patients 12 years of age and older. (1.2) DOSAGE AND ADMINISTRATION DOSAGE (BY AGE): (2) ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OVER: (2) Desloratadine Tablets - one 5 mg tablet once daily DOSAGE FORMS AND STRENGTHS Desloratadine tablets USP - 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 tablets 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 LUPIN PHARMACEUTICALS, INC. AT 1-800- 399-2561 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-APPROVED PATIENT LABELING. REVISED: 2/2023 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Seasonal Allergic Rhinitis 1.2 Perennial Allergic Rhinitis 2 DOSAGE AND ADMINISTRATION 2.1 Adults and Adolescents 12 Years of Age and Over 2.5 Adults with Hepatic or Ren Preberite celoten dokument