XYZAL- levocetirizine dihydrochloride tablet, film coated 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:

Sanofi-Aventis U.S. LLC

INN (International Name):

levocetirizine dihydrochloride

Composition:

levocetirizine dihydrochloride 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

XYZAL is indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. 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 <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 of miscarriage, birth defects, or adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm with administration

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 unit of use HDPE bottles. 90 Tablets (NDC 0024-5803-90) XYZAL oral solution is a clear, colorless liquid containing 0.5 mg of levocetirizine dihydrochloride per mL. Oral Solution in 5 oz polypropylene bottles (NDC 0024-5804-05) 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].

Authorization status:

New Drug Application

Summary of Product characteristics

XYZAL- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED
XYZAL- LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION
SANOFI-AVENTIS U.S. LLC
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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) TABLETS, FOR ORAL USE
XYZAL (LEVOCETIRIZINE DIHYDROCHLORIDE) ORAL SOLUTION
INITIAL U.S. APPROVAL: 1995
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) (2.5 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 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 nervous system
depressants with XYZAL. (5.1)
Use with caution in patients with predisposing