LEVOCETIRIZINE DIHYDROCHLORIDE- 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:

Micro Labs Limited

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 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 are 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) and patients undergoing hemodialysis Children 6 months to 11 years of age with impaired renal function Risk Summary Available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient

Product summary:

Levocetirizine dihydrochloride tablets, USP are white to off white, oval shaped biconvex, film-coated tablet debossed with 'I' and '12' on one side and score line on the other side and contain 5 mg levocetirizine dihydrochloride. They are supplied in 1) Bottles of 30's tablets                                 NDC 42571-122-30 2) Bottles of 90's tablets                                 NDC 42571-122-90 3) Bottles of 500's tablets                               NDC 42571-122-05 4) Carton of 10x10 Unit-dose Tablets            NDC 42571-122-32 Storage: Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF 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
MICRO LABS LIMITED
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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 is a histamine H
-receptor antagonist indicated for:
The relief of symptoms associated with perennial allergic rhinitis (
1.1)
The treatment of the uncomplicated skin manifestations of chronic
idiopathic urticaria ( 1.2)
DOSAGE AND ADMINISTRATION
CHRONIC IDIOPATHIC URTICARIA ( 2.2)
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)
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 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 adverse reactions (rate ≥2%