XYZAL- levocetirizine dihydrochloride tablet XYZAL- levocetirizine dihydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O)

Available from:

Physicians Total Care, Inc.

INN (International Name):

LEVOCETIRIZINE DIHYDROCHLORIDE

Composition:

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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].

Authorization status:

New Drug Application

Summary of Product characteristics

XYZAL - LEVOCETIRIZINE DIHYDROCHLORIDE TABLET
XYZAL - LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION
PHYSICIANS TOTAL CARE, INC.
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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