LEVOCETIRIZINE DIHYDROCHLORIDE solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O)

Предлага се от:

NuCare Pharmaceuticals,Inc.

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 oral solution is contraindicated in: Patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride oral solution, 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

Каталог на резюме:

Levocetirizine dihydrochloride oral solution is a clear, colorless liquid containing 0.5 mg of levocetirizine dihydrochloride per mL. Oral Solution available in 5 oz (148 mL) polypropylene container (with FSE wad) NDC 68071-2836-8 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].

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE
SOLUTION
NUCARE PHARMACEUTICALS,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 is a histamine
H1-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 (1/2 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 (1/2 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 or to cetirizine (4.1)
dihydrochloride oral solution 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 oral
solution. (5.