Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O)
Physicians Total Care, Inc.
LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Enter section text here XYZAL® is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older. XYZAL is indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months of age and older. 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 less than 10 mL/min) and patients undergoing hemodialysis Children 6 months to 11 years of age with impaired renal function Enter section text here Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Because animal reproduction s
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 bottles of: 30 Tablets NDC 54868-5829-0 XYZAL oral solution is a clear, colorless liquid containing 0.5 mg of levocetirizine dihydrochloride per mL. Oral solution in 5 oz glass bottles NDC 54868-6115-0 Storage: Store at 20-25°C (68-77°F); excursions permitted to 15‑30°C (59-86°F) [see USP Controlled Room Temperature].
New Drug Application
XYZAL - LEVOCETIRIZINE DIHYDROCHLORIDE TABLET XYZAL - LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION PHYSICIANS TOTAL CARE, 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) 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 alcoho Lestu allt skjalið