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:

Carlsbad Technology, 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 seasonal allergic rhinitis in adults and children 6 years of age and older. Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and 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 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 (CL CR < 10 mL/min)

Product summary:

Levocetirizine Dihydrochloride Tablets, 5 mg are white, oval, biconvex, film-coated, functional scored tablets debossed with “S” on the left side of bisect and “G” on the right side of bisect and other side “1” on the left side and “36” on the right side of the bisect. They are supplied in unit of use HDPE bottles. NDC 61442-460-90: Bottles of 90 tablets 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,
FILM COATED
CARLSBAD TECHNOLOGY, INC.
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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 tablets are a histamine H1-receptor
antagonist indicated for:
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)
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 (functional scored) tablets, 5 mg ( 3)
CONTRAINDICATIONS
Patients with a known hypersensitivity to levocetirizine or any of the
ingredients of levocetirizine dihydrochloride
tablets or to cetirizine ( 4.1)
Patients with end-stage renal disease at less than 10 mL/min
creatinine clearance or patients undergoing hemodialysis (
4.2)
Children 6 months to 11 years of age with renal impairment ( 4.3)
WARNINGS AND PRECAUTIONS
Avoid engaging in hazardous occupations requiring complete mental
alertness such as driving or operating machinery
when taking levocetirizine dihydrochloride ( 5.1).
Avoid concurrent use of alcohol or other central nervous system
depressants with levocetirizine dihydrochloride ( 5.1).
Use with caution in patients with predisposing factors of urinary
retention (e.g., spinal cord lesion, prostatic hyperplasia).
Discontinue levocetirizine dihydrochloride if urinary retention occurs
( 5.2).
ADVERSE REACTIONS
The most common adv