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:

YILING PHARMACEUTICAL, INC.

INN (International Name):

LEVOCETIRIZINE DIHYDROCHLORIDE

Composition:

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1.2 Chronic Idiopathic Urticaria Levocetirizine dihydrochloride is 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 tablet is contraindicated in: 4.1 Patients with known hypersensitivity 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)]. 4.2 Patients with end-stage renal disease Patients with end-stage renal disease (CLCR < 10 mL/min) and patients undergoing hemodialysis 4.3 Pediatric patients with impaired renal function Children 6 months to 11 years of age with impaired renal function 8.1 Pregnancy Risk Summary Available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-ass

Product summary:

Levocetirizine dihydrochloride tablets, USP 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. 90 Tablets (NDC 69117-1000-1) 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
YILING PHARMACEUTICAL, 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 treatment of the uncomplicated skin manifestations of chronic
idiopathic urticaria (1.2) (1)
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) (2)
DOSAGE FORMS AND STRENGTHS
• Immediate release breakable (functional scored) tablets, 5 mg (3)
(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)
(4)
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). (5)
ADVERSE REACTIONS
The most common adverse reactions (rate ≥2% and > placebo) were
somn