Country: United States
Language: English
Source: NLM (National Library of Medicine)
LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O)
Bryant Ranch Prepack
LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. The use of levocetirizine dihydrochloride is contraindicated in: Patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride, or to cetirizine. Observed reactions range from urticaria to anaphylaxis [see Adverse Reactions (6.2) ]. Patients with end-stage renal disease (CLCR < 10 mL/min) and patients undergoing hemodialysis. Children 6 months to 11 years of age with impaired renal function. Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, levocetirizine dihydrochloride should be used
Product: 63629-4492 NDC: 63629-4492-3 28 TABLET in a BOTTLE NDC: 63629-4492-1 30 TABLET in a BOTTLE
Abbreviated New Drug Application
LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS. LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1995 RECENT MAJOR CHANGES Indications and Usage (1.1) 02/2017 Dosage and Administration (2.1), (2.2) 02/2017 INDICATIONS AND USAGE Levocetirizine dihydrochloride tablets are a histamine H -receptor antagonist indicated for: • • DOSAGE AND ADMINISTRATION PERENNIAL ALLERGIC RHINITIS (2.1) • CHRONIC IDIOPATHIC URTICARIA (2.2) • • • • • DOSAGE FORMS AND STRENGTHS Immediate release breakable (scored) tablets, 5 mg (3) CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS • • • ADVERSE REACTIONS The most common adverse reactions (rate ≥2% and > placebo) were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis in subjects 12 years of age and older, and pyrexia, somnolence, cough, and epistaxis in children 6 to 12 years of age. In subjects 1 to 5 years of age, the most common adverse reactions (rate ≥2% and > placebo) were pyrexia, diarrhea, vomiting, and otitis media. In subjects 6 to 11 months of age, the most common adverse reactions (rate ≥3% and > placebo) were diarrhea and constipation. (6.1). TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLENMARK PHARMACEUTICALS INC., USA AT 1 (888)721- 7115 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. 1 The relief of symptoms associated with perennial allergic rhinitis (1.1) The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.2) Children 6 months to 2 years of age: 1.25 mg once daily in the evening Adults and children 12 years of age and older: 5 mg once daily in the evening Children 6 to 11 years of age: 2.5 mg once daily in the evening Children 6 months to 5 years of age: 1.25 mg Read the complete document