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:

Apotex Corp.

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. Risk Summary Available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth

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 90s         NDC 60505-3713-9 Bottles of 500s       NDC 60505-3713-5 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
APOTEX CORP.
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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 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 tablets (with functional scoring), 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 tablets if urinary
retention occurs. (5.2)
ADVERSE REACTIONS
The most common adverse reactions (rate ≥2