Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O)
Apotex Corp.
LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDE 0.5 mg in 1 mL
ORAL
PRESCRIPTION DRUG
Levocetirizine dihydrochloride oral solution is indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. Levocetirizine dihydrochloride oral solution 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 levocetirizine dihydrochloride oral solution is contraindicated in: Patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride oral solution, 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 o
Levocetirizine dihydrochloride oral solution is a clear, colorless liquid with fruit aroma containing 0.5 mg of levocetirizine dihydrochloride per mL. Oral solution in 148 mL (5 oz) plastic bottles (NDC 60505-0403-3) STORAGE Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION APOTEX CORP. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION. LEVOCETIRIZINE DIHYDROCHLORIDE, ORAL SOLUTION INITIAL U.S. APPROVAL: 1995 INDICATIONS AND USAGE Levocetirizine dihydrochloride oral solution 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 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 levocetirizine dihydrochloride oral solution 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 oral solution. (5.1) Avoid concurrent use of alcohol or other central nervous system depressants with levocetirizine dihydrochloride Đọc toàn bộ tài liệu