Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O)
Padagis Israel Pharmaceuticals Ltd
LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDE 0.5 mg in 1 mL
ORAL
PRESCRIPTION DRUG
Levocetirizine dihydrochloride is indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. Levocetirizine dihydrochloride 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 is contraindicated in: Patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride, 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 post-marketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or
Levocetirizine dihydrochloride oral solution is a clear, colorless liquid containing 0.5 mg of levocetirizine dihydrochloride per mL. Oral solution in 150 mL PET plastic bottles (NDC 45802-680 -28) 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].
Abbreviated New Drug Application
LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION PADAGIS ISRAEL PHARMACEUTICALS LTD ---------- 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 is a histamine H -receptor antagonist indicated for: • • DOSAGE AND ADMINISTRATION PERENNIAL ALLERGIC RHINITIS (2.1) • CHRONIC IDIOPATHIC URTICARIA (2.2) • • • • Adjust the dose in patients 12 years of age and older with decreased renal function (12.3) DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS • • • ADVERSE REACTIONS The most common adverse reactions (rate ≥2% and > placebo) were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis in subjects 12 years of age and older, and pyrexia, somnolence, cough, and epistaxis in children 6 to 12 years of age. In subjects 1 to 5 years of age, the most common adverse reactions (rate ≥2% and >placebo) were pyrexia, diarrhea, vomiting, and otitis media. In subjects 6 to 11 months of age, the most common adverse reactions (rate ≥3% and >placebo) were diarrhea and constipation (6.1). TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PADAGIS AT 1-866-634-9120 OR FDA AT 1- 1 The relief of symptoms associated with perennial allergic rhinitis (1.1) The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.2) Children 6 months to 2 years of age: 1.25 mg (1/2 teaspoon oral solution) (2.5mL) once daily in the evening 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 Immedia Lees het volledige document