Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
levocetirizine dihydrochloride (UNII: SOD6A38AGA) (levocetirizine - UNII:6U5EA9RT2O)
Vensun Pharmaceuticals, Inc.
levocetirizine dihydrochloride
levocetirizine dihydrochloride 5 mg
ORAL
PRESCRIPTION DRUG
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 tablet 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 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 during pregnancy only if clearly needed. Teratogenic Effects In rats and rabbits, levocetirizine was not teratogenic at oral doses approximately 320 a
Levocetirizine Dihydrochloride Tablets, USP 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: 42543-712-30: Bottles of 30 tablets NDC: 42543-712-90: Bottles of 90 tablets NDC: 42543-712-03: Bottles of 300 tablets Storage: Store at 20 to 25°C (68 to 77°F); excursion permitted to 15 to 30°C (59 to 86°F) [see USP Controlled room temperature].
Abbreviated New Drug Application
LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET VENSUN 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 TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1995 INDICATIONS AND USAGE Levocetirizine dihydrochloride tablets are a histamine H receptor antagonist indicated for: The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.2) DOSAGE AND ADMINISTRATION CHRONIC IDIOPATHIC URTICARIA (2.2) 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 Renal Impairment Adjust the dose in patients 12 years of age and older with decreased renal function (12.3) DOSAGE FORMS AND STRENGTHS Immediate release breakable (functional 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 (4.1) Patients with end-stage renal disease at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis (4.2) Children 6 months to 11 years of age with renal impairment (4.3) WARNINGS AND PRECAUTIONS Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking levocetirizine dihydrochloride (5.1). Avoid concurrent use of alcohol or other central nervous system depressants with levocetirizine dihydrochloride (5.1). Use with caution in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia). Discontinue levocetirizine dihydrochloride if urinary retention occurs (5.2). ADVERSE REACTIONS The most common adverse reactions (rate ≥2% and > placebo) were somnolence, nasopharyngitis, fatigue, dry mouth, a Lees het volledige document