XYZAL levocetirizine dihydrochloride tablet film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Sanofi-Aventis U.S. LLC

INN (Nome Internazionale):

levocetirizine dihydrochloride

Composizione:

levocetirizine dihydrochloride 5 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

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)
5 MG TABLETS
2.5 MG/5 ML (0.5 MG/ML) 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 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 (4.1)
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 factors of urinary
retention (e.g. spinal cord lesion, prostatic hyperplasia).
Discontinue XYZAL if urinary retention occurs (5.2).
ADVERSE REACTIONS
The most co