Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
levocetirizine dihydrochloride (UNII: SOD6A38AGA) (levocetirizine - UNII:6U5EA9RT2O)
UCB Farchim S.A.
levocetirizine dihydrochloride
levocetirizine dihydrochloride 5 mg
PRESCRIPTION DRUG
New Drug Application
XYZAL- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET UCB FARCHIM S.A. ---------- 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) 5 MG TABLETS 2.5 MG/5 ML (0.5 MG/ML) ORAL SOLUTION INITIAL U.S. APPROVAL: 1995 RECENT MAJOR CHANGES Indications and Usage, Seasonal Allergic Rhinitis (1.1) 08/2009 Indications and Usage, Perennial Allergic Rhinitis (1.2) 08/2009 Indications and Usage, Chronic Idiopathic Urticaria (1.3) 08/2009 Dosage and Administration, Children 6 months to 5 Years (2.3) 08/2009 INDICATIONS AND USAGE XYZAL is 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) Children 6 months to 5 years of age: 1.25 mg (1/2 teaspoon oral solution) [2.5mL] once daily in the evening (2.3) 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) 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) 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 XYZAL (5.1). Avoid concurrent use of alcohol or other central nervous system depressants with XYZAL (5. Olvassa el a teljes dokumentumot