Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
levocetirizine dihydrochloride (UNII: SOD6A38AGA) (levocetirizine - UNII:6U5EA9RT2O)
Sanofi-Aventis U.S. LLC
levocetirizine dihydrochloride
levocetirizine dihydrochloride 5 mg
ORAL
PRESCRIPTION DRUG
XYZAL is indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. XYZAL is 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 XYZAL is contraindicated in: Patients with known hypersensitivity to levocetirizine or any of the ingredients of XYZAL, 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 Risk Summary Available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm with administration
XYZAL tablets are white, film-coated, oval-shaped, scored, imprinted (with the letter Y in red color on both halves of the scored tablet) and contain 5 mg levocetirizine dihydrochloride. They are supplied in unit of use HDPE bottles. 90 Tablets (NDC 0024-5803-90) XYZAL oral solution is a clear, colorless liquid containing 0.5 mg of levocetirizine dihydrochloride per mL. Oral Solution in 5 oz polypropylene bottles (NDC 0024-5804-05) Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
New Drug Application
XYZAL- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED XYZAL- LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION SANOFI-AVENTIS U.S. LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE XYZAL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XYZAL. XYZAL (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLETS, FOR ORAL USE XYZAL (LEVOCETIRIZINE DIHYDROCHLORIDE) ORAL SOLUTION INITIAL U.S. APPROVAL: 1995 INDICATIONS AND USAGE XYZAL is a histamine H -receptor antagonist indicated for: The relief of symptoms associated with perennial allergic rhinitis (1.1) The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.2) DOSAGE AND ADMINISTRATION PERENNIAL ALLERGIC RHINITIS (2.1) Children 6 months to 2 years of age: 1.25 mg (1/2 teaspoon oral solution) (2.5 mL) once daily in the evening 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 Children 6 months to 5 years of age: 1.25 mg (1/2 teaspoon oral solution) (2.5 mL) 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 (scored) tablets, 5 mg (3) Immediate release oral solution, 2.5 mg per 5 mL (0.5 mg per mL) (3) CONTRAINDICATIONS Patients with a known hypersensitivity to levocetirizine or any of the ingredients of XYZAL 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 XYZAL. (5.1) Avoid concurrent use of alcohol or other central nervous system depressants with XYZAL. (5.1) Use with caution in patients with predisposing Lesen Sie das vollständige Dokument