País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
Levocetirizine dihydrochloride (UNII: SOD6A38AGA) (Levocetirizine - UNII:6U5EA9RT2O)
Synthon Pharmaceuticals, Inc.
Levocetirizine dihydrochloride
Levocetirizine dihydrochloride 5 mg
ORAL
PRESCRIPTION DRUG
Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. Pediatric use information in pediatric patients (age 2 to 5 years) with seasonal allergic rhinitis is approved for UCB Inc.'s levocetirizine dihydrochloride drug product. However, due to UCB Inc.'s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 years of age and older. Pediatric use information in pediatric patients (age 6 months to 5 years) with perennial allergic rhinitis is approved for UCB Inc.'s levocetirizine dihydrochloride drug product. However, due to UCB Inc.'s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. Levocetirizine dihydrochloride tablets are indicated for the trea
Levocetirizine dihydrochloride tablets are white to off-white, film-coated, scored, oval, biconvex, debossed with "L9CZ 5" on the unscored side and nothing on the scored side, and contain 5 mg levocetirizine dihydrochloride. They are supplied in unit of use HDPE bottles. 30 Tablets (NDC 63672-0051-1) Storage: Store 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
LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED SYNTHON PHARMACEUTICALS, INC. ---------- 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 5 MG TABLETS INITIAL U.S. APPROVAL: 1995 INDICATIONS AND USAGE Levocetirizine dihydrochloride tablets are a histamine H -receptor antagonist indicated for: The relief of symptoms associated with seasonal and perennial allergic rhinitis (1.1, 1.2) The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.3) DOSAGE AND ADMINISTRATION Adults and children 12 years of age and older: 5 mg once daily in the evening (2.1) Children 6 to 11 years of age: 2.5 mg once daily in the evening (2.2) Renal Impairment Adjust the dose in patients 12 years of age and older with decreased renal function (2.4, 12.3) DOSAGE FORMS AND STRENGTHS Immediate release breakable (scored) tablets, 5 mg (3) CONTRAINDICATIONS Patients with a known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets or to cetirizine (4) Patients with end-stage renal disease at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis (4) Children 6 months to 11 years of age with renal impairment (4) WARNINGS AND PRECAUTIONS Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking levocetirizine dihydrochloride tablets (5.1). Avoid concurrent use of alcohol or other central nervous system depressants with levocetirizine dihydrochloride tablets (5.1). 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 Llegiu el document complet