LEVOCETIRIZINE DIHYDROCHLORIDE- 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:

Preferred Pharmaceuticals Inc.

INN (International Name):

LEVOCETIRIZINE DIHYDROCHLORIDE

Composition:

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

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 months to 2 years of age. Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. The use of levocetirizine dihydrochloride tablets is 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 (CLCR < 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 are not always predictive of human response, levocetirizine dihydrochloride

Product summary:

Levocetirizine dihydrochloride tablets, USP are white to off-white, film-coated, biconvex, oval shaped tablets with functional scoring; engraved "APO" on one side, “L” score “5” on the other side and contain 5 mg levocetirizine dihydrochloride. They are supplied  as follows: Bottles of 30s         NDC 68788-6892-3 Bottles of 60s         NDC 68788-6892-6 Bottles of 90s         NDC 68788-6892-9 Bottles of 100s         NDC 68788-6892-1 Storage Store levocetirizine dihydrochloride tablets at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container [see USP].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET
PREFERRED PHARMACEUTICALS INC.
----------
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 tablets are a histamine H -receptor
antagonist indicated for:
3.
4.
DOSAGE AND ADMINISTRATION
CHRONIC IDIOPATHIC URTICARIA (2.2)
4.
5.
6.
DOSAGE FORMS AND STRENGTHS
2.
CONTRAINDICATIONS
4.
5.
6.
WARNINGS AND PRECAUTIONS
4.
5.
6.
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 APOTEX CORP. AT
1-800-706-5575 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
3.
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
Adjust the dose in patients 12 years of age and older with decreased
renal function (12.3)
Immediate release breakable tablets (with functional scoring), 5 mg
(3)
Patients with a known hypersensitivity to levocetirizine or any of the
ingredients of levocetirizine dihydrochloride
tablets or to