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:

A-S Medication Solutions

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 is contraindicated in: Patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride, 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 should be used

Product summary:

Product: 50090-2061 NDC: 50090-2061-0 30 TABLET in a BOTTLE NDC: 50090-2061-1 90 TABLET in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET
A-S MEDICATION SOLUTIONS
----------
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
RECENT MAJOR CHANGES
Indications and Usage (1.1) 02/2017
Dosage and Administration (2.1), (2.2) 02/2017
INDICATIONS AND USAGE
Levocetirizine dihydrochloride tablets are a histamine H -receptor
antagonist indicated for:
•
•
DOSAGE AND ADMINISTRATION
PERENNIAL ALLERGIC RHINITIS (2.1)
•
CHRONIC IDIOPATHIC URTICARIA (2.2)
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Immediate release breakable (scored) tablets, 5 mg (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
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 GLENMARK
PHARMACEUTICALS INC., USA AT 1 (888)721-
7115 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
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)
Children 6 months to 2 years of age: 1.25 mg once daily in the evening
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
Children 6 months to 5 years of age: 1.2