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:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 years of age and older. Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. The use of levocetirizine dihydrochloride tablets are contraindicated in: Patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. Observed reactions range from urticaria to anaphylaxis [see Adverse Reactions ( 6.2) ]. Patients with end-stage renal disease (CL CR < 10 mL/min) and patients undergoing hemodialysis Children 6 months to 11 years of age with impaired renal function Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies ar

Product summary:

Levocetirizine dihydrochloride tablets, USP are white to off white, oval shaped biconvex, film-coated tablet debossed with 'I' and '12' on one side and score line on the other side and contain 5 mg levocetirizine dihydrochloride. They are supplied in 1) Bottles of 30's tablets                                 NDC 71205-210-30 2) Bottles of 60's tablets                               NDC 71205-210-60 3) Bottles of 90's tablets                               NDC 71205-210-90 Storage: Store at 20 to 25ºC (68 to 77ºF); excursions permitted to 15 to 30ºC (59 to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET,
FILM COATED
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOCETIRIZINE DIHYDROCHLORIDE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVOCETIRIZINE DIHYDROCHLORIDE
TABLETS.
LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Levocetirizine dihydrochloride is a histamine H
-receptor antagonist indicated for:
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DOSAGE AND ADMINISTRATION
CHRONIC IDIOPATHIC URTICARIA ( 2.2)
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•
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Adjust the dose in patients 12 years of age and older with decreased
renal function ( 12.3)
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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, and pyrexia,
somnolence, cough, and epistaxis in children 6 to 12 years of
age. In subjects 1 to 5 years of age, the most common adverse
reactions (rate ≥2% and > placebo) were pyrexia, diarrhea,
vomiting, and otitis media. In subjects 6 to 11 months of age, the
most common adverse reactions (rate ≥3% and >
placebo) were diarrhea and constipation. ( 6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MICRO LABS USA, INC. AT
1-855-839-8195 OR FDA AT 1-
800-FDA-1088 OR www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
•
1
The relief of symptoms associated with perennial allergic rhinitis (
1.1)
The treatment of the uncomplicated skin manifestations of chronic
idiopathic urticaria ( 1.2)
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
Renal Impairment
Immediate release breakable (scored) tablets, 5 mg ( 3)
Patients with a known hypersensitivity to levocetirizine or any of the
ingredients of levocetirizine dihydrochloride
tablets or to