XYZAL levocetirizine dihydrochloride tablet film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

levocetirizine dihydrochloride (UNII: SOD6A38AGA) (levocetirizine - UNII:6U5EA9RT2O)

Tilgjengelig fra:

UCB, Inc.

INN (International Name):

levocetirizine dihydrochloride

Sammensetning:

levocetirizine dihydrochloride 5 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

New Drug Application

Preparatomtale

XYZAL- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED
XYZAL- LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION
UCB, 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) TABLETS, FOR ORAL USE
XYZAL (LEVOCETIRIZINE DIHYDROCHLORIDE) ORAL SOLUTION
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Indications and Usage (1.1)
02/2017
Dosage and Administration (2.1), (2.2)
02/2017
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) [2.5mL] 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) [2.5mL] 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 ner