Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
DESLORATADINE (UNII: FVF865388R) (DESLORATADINE - UNII:FVF865388R)
Virtus Pharmaceuticals
Desloratadine
Desloratadine 5 mg
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 indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 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
Desloratadine Tablets: Debossed "5", light blue, round tablets that are packaged in high-density polyethylene plastic bottles of 100 (NDC 69543-107-10) and 500 (NDC 69543-107-50). Storage
Abbreviated New Drug Application
DESLORATADINE- DESLORATADINE TABLET VIRTUS PHARMACEUTICALS ---------- 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 A HISTAMINE-1 (H1) RECEPTOR ANTAGONIST INDICATED FOR: • • • DOSAGE AND ADMINISTRATION DOSAGE (BY AGE): ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OVER: • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • ADVERSE REACTIONS • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT VIRTUS PHARMACEUTICALS, LLC AT 1-888- 848-3593 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. USE IN SPECIFIC POPULATIONS • • SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 10/2020 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) CHRONIC IDIOPATHIC URTICARIA: symptomatic relief of pruritus, reduction in the number of hives, and size of hives in patients 12 years of age and older. (1.3) Desloratadine Tablets - one 5 mg tablet once daily (2) Desloratadine Tablets - 5 mg (3) Hypersensitivity (4, 6.2) 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) 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) Renal impairment: dosage adjustment is recommended (2.5, 8.6, 12.3) Hepatic impairment: dosage adjustment is recommended (2.5, 8.7, 12.3) FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND Baca dokumen lengkap