LEVOCETIRIZINE DIHYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Perrigo New York Inc

INN (International Name):

LEVOCETIRIZINE DIHYDROCHLORIDE

Composition:

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levocetirizine dihydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older. Pediatric use information in pediatric patients (age 2 to 5 years) with seasonal allergic rhinitis is approved for UCB Inc.’s levocetirizine dihydrochloride drug product. However, due to UCB Inc.’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. Levocetirizine dihydrochloride is indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months of age and older. Pediatric use information in pediatric patients (age 6 months to 5 years) with perennial allergic rhinitis is approved for UCB Inc.’s levocetirizine dihydrochloride drug product. However, due to UCB Inc.’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. Levocetirizine dihydrochloride is indicated for the treatment of the uncomplicated

Product summary:

Levocetirizine dihydrochloride tablets are white to off-white, film-coated, scored, oval, biconvex, debossed with “L9CZ 5” on the unscored side and nothing on the scored side, and contain 5 mg levocetirizine dihydrochloride. They are supplied in the following HDPE bottle configurations: 30 Tablets (NDC 45802-594 -65) (Unit of Use) 90 Tablets (NDC 45802-594 -75) (Unit of Use) 300 Tablets (NDC 45802-594 -87) Storage: Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET
PERRIGO NEW YORK INC
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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
INDICATIONS AND USAGE
Levocetirizine dihydrochloride is a histamine H -receptor antagonist
indicated for: (1)
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DOSAGE AND ADMINISTRATION
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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 Synthon
Pharmaceuticals, Inc. at 1-919-493-6006 or FDA at 1-
800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
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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)
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) [2.5 mL] 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)
Immediate release breakable (scored) tablets, 5 mg (3)