LEVOCETIRIZINE DIHYDROCHLORIDE tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Winthrop U.S.

INN (International Name):

levocetirizine dihydrochloride

Composition:

levocetirizine dihydrochloride 5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

LEVOCETIRIZINE DIHYDROCHLORIDE - LEVOCETIRIZINE DIHYDROCHLORIDE
TABLET, FILM COATED
LEVOCETIRIZINE DIHYDROCHLORIDE - LEVOCETIRIZINE DIHYDROCHLORIDE
SOLUTION
WINTHROP U.S.
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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,
5 MG TABLETS
2.5 MG/5 ML (0.5 MG/ML) ORAL SOLUTION
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Warnings and Precautions, Urinary Retention (5.2)
[09/2012]
INDICATIONS AND USAGE
Levocetirizine Dihydrochloride 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 Levocetirizine Dihydrochloride 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 Levocetirizine Dihydrochloride (5.1).
Avoid concurrent use of alcohol or other central nervous system
dep