国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
levocetirizine dihydrochloride (UNII: SOD6A38AGA) (levocetirizine - UNII:6U5EA9RT2O)
UCB, Inc.
levocetirizine dihydrochloride
levocetirizine dihydrochloride 5 mg
PRESCRIPTION DRUG
New Drug Application
XYZAL- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED XYZAL- LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION UCB, INC. ---------- 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 RECENT MAJOR CHANGES Indications and Usage (1.1) 02/2017 Dosage and Administration (2.1), (2.2) 02/2017 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) [2.5mL] 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) [2.5mL] 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 ner 完全なドキュメントを読む