Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
levocetirizine dihydrochloride (UNII: SOD6A38AGA) (levocetirizine - UNII:6U5EA9RT2O)
Proficient Rx LP
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. 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. Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. The use of levocetirizine dihydrochloride tablets is contraindicated in: Patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, 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
Levocetirizine Dihydrochloride Tablets, 5 mg are white, oval, biconvex, film-coated functional scored tablets debossed with “S” on the left side of bisect and “G” on the right side of bisect and other side “1” on the left side and “36” on the right side of the bisect. They are supplied in unit of use HDPE bottles. NDC 63187-663-30: Bottle of 30 tablets NDC 63187-663-60: Bottle of 60 tablets NDC 63187-663-90: Bottle of 90 tablets Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET PROFICIENT RX LP ---------- 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 INDICATIONS AND USAGE Levocetirizine dihydrochloride tablets are a histamine H receptor antagonist indicated for: • • DOSAGE AND ADMINISTRATION 4. 5. 6. DOSAGE FORMS AND STRENGTHS 2. CONTRAINDICATIONS 4. 5. 6. WARNINGS AND PRECAUTIONS 4. 5. 6. 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 VENSUN PHARMACEUTICALS, INC. AT 1-800-385-1540 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. USE IN SPECIFIC POPULATIONS 3. 4. 1 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) 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) Immediate release breakable (functional scored) tablets, 5 mg (3) Patients with a known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets or to Läs hela dokumentet