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:

Aidarex Pharmaceuticals LLC

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 treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.   Pediatric use information in pediatric patients (age 6 months to 5 years) is approved for UCB Inc.’s levocetirizine dihydrochloride drug product labeling. However, due to UCB Inc.’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. The use of levocetirizine dihydrochloride tablet is contraindicated in: Patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablet, 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 i

Product summary:

Levocetirizine dihydrochloride tablets are white, film-coated, oval-shaped tablets debossed with ‘S’ on one side and breakline on other side and contain 5 mg levocetirizine dihydrochloride. They are supplied in HDPE bottles as follows:   Bottles of 30’s ……………NDC 33261-0947-30 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET,
FILM COATED
AIDAREX PHARMACEUTICALS LLC
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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, 5 MG
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Warnings and Precautions, Urinary Retention (5.2) [09/2012]
INDICATIONS AND USAGE
Levocetirizine dihydrochloride tablet is a histamine H -receptor
antagonist indicated for:
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)
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)
CONTRAINDICATIONS
Patients with a known hypersensitivity to levocetirizine or any of the
ingredients of levocetirizine dihydrochloride tablet
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 tablets (5.1).
Avoid concurrent use of alcohol or other central nervous system
depressants with levocetirizine dihydrochloride
tablets (5.1).
Use with caution in patients with predisposing factors of urinary
retention (e.g. spinal cord lesion, prostatic hyperplasia).
Discontinue levocetirizine dihydrochloride tablets if urinary
retention occurs (5.2).
ADVERSE REACTIONS
The most common adverse reactions (rate ≥2