LEVOCETIRIZINE DIHYDROCHLORIDE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

American Health Packaging

INN (International Name):

LEVOCETIRIZINE DIHYDROCHLORIDE

Sammensætning:

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

Recept type:

PRESCRIPTION DRUG

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET
AMERICAN HEALTH PACKAGING
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOCETIRIZINE DIHYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVOCETIRIZINE
DIHYDROCHLORIDE.
LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Levocetirizine dihydrochloride is a histamine H
-receptor antagonist indicated for:
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)
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)
CONTRAINDICATIONS
Patients with a known hypersensitivity to levocetirizine or any of the
ingredients of levocetirizine dihydrochloride
tablets 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 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 levocetirizine dihydrochloride ( 5.1).
Avoid concurrent use of alcohol or other central nervous system
depressants with levocetirizine dihydrochloride ( 5.1).
Use with caution in patients with predisposing factors of urinary
retention (e.g. spinal cord lesion, prostatic hyperplasia).
Discontinue levocetirizine dihydrochloride if urinary retention occurs
( 5.2).
ADVERSE REACTIONS
The most common adverse reactions (rate ≥2% and > placebo) were
somnolence, nasopharyngitis, fatigue, dry mouth, and
pharyngitis in subjects 12 years of age and older,