LEVOCETIRIZINE DIHYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Levocetirizine dihydrochloride (UNII: SOD6A38AGA) (Levocetirizine - UNII:6U5EA9RT2O)

Available from:

Taro Pharmaceuticals U.S.A., inc.

INN (International Name):

Levocetirizine dihydrochloride

Composition:

Levocetirizine dihydrochloride 0.5 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levocetirizine dihydrochloride oral solution is indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. Levocetirizine dihydrochloride oral solution 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 is contraindicated in: Patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride, 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 defects,

Product summary:

Levocetirizine Dihydrochloride Oral Solution is a clear, colorless, tutti frutti flavored liquid containing 0.5 mg of levocetirizine dihydrochloride per mL and is supplied in: 2 fl oz (59 mL) bottles (NDC 51672-4161-4) 4 fl oz (118 mL) bottles (NDC 51672-4161-8) 6 fl oz (177 mL) bottles (NDC 51672-4161-5) 8 fl oz (237 mL) bottles (NDC 51672-4161-1) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE
SOLUTION
TARO PHARMACEUTICALS U.S.A., INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION.
LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Levocetirizine Dihydrochloride Oral Solution, 2.5 mg/5 mL (0.5 mg/mL)
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
PERENNIAL ALLERGIC RHINITIS ( 2.1)
Children 6 months to 2 years of age: 1.25 mg (½ teaspoon oral
solution) [2.5 mL] once daily in the evening
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
Children 6 months to 5 years of age: 1.25 mg (½ teaspoon oral
solution) [2.5 mL] 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 oral solution, 2.5 mg per 5 mL (0.5 mg per mL) (3)
CONTRAINDICATIONS
Patients with a known hypersensitivity to levocetirizine or any of the
ingredients of levocetirizine dihydrochloride oral solution, 2.5
mg/5 mL (0.5 mg/mL) 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