Country: United States
Language: English
Source: NLM (National Library of Medicine)
DESLORATADINE (UNII: FVF865388R) (DESLORATADINE - UNII:FVF865388R)
Belcher Pharmaceuticals,LLC
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)]. 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
Desloratadine Tablets: Debossed “5”, light blue, round tablets that are packaged in high-density polyethylene plastic bottles of 30 (NDC 62250-619-01), 100 (NDC 62250-619-02) and 500 (NDC 62250-619-08). Storage: Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Abbreviated New Drug Application
DESLORATADINE- DESLORATADINE TABLET BELCHER PHARMACEUTICALS,LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION DESLORATADINE TABLETS THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DESLORATADINE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DESLORATADINE. DESLORATADINE (DESLORATADINE) TABLET FOR ORAL USE. INITIAL U.S. APPROVAL: 2001 INDICATIONS AND USAGE Desloratadine Tablets are 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) 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) 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 - 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 BELCHER PHARMACEUTICALS LLC AT 1-727- 471-0850 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. REVISED: 12/2012 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 SEASONAL ALLERGIC RHINITIS 1.2 PERENNIAL ALLERGIC RHINITIS 1.3 Read the complete document