LEVOCETIRIZINE DIHYDROCHLORIDE solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Padagis Israel Pharmaceuticals Ltd

INN (International Nazwa):

LEVOCETIRIZINE DIHYDROCHLORIDE

Skład:

LEVOCETIRIZINE DIHYDROCHLORIDE 0.5 mg in 1 mL

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Levocetirizine dihydrochloride is indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. 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 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 post-marketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or

Podsumowanie produktu:

Levocetirizine dihydrochloride oral solution is a clear, colorless liquid containing 0.5 mg of levocetirizine dihydrochloride per mL. Oral solution in 150 mL PET plastic bottles (NDC 45802-680 -28) Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE
SOLUTION
PADAGIS ISRAEL PHARMACEUTICALS LTD
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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 is a histamine H -receptor antagonist
indicated for:
•
•
DOSAGE AND ADMINISTRATION
PERENNIAL ALLERGIC RHINITIS (2.1)
•
CHRONIC IDIOPATHIC URTICARIA (2.2)
•
•
•
•
Adjust the dose in patients 12 years of age and older with decreased
renal function (12.3)
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
The most common adverse reactions (rate ≥2% and > placebo) were
somnolence, nasopharyngitis,
fatigue, dry mouth, and pharyngitis in subjects 12 years of age and
older, and pyrexia, somnolence,
cough, and epistaxis in children 6 to 12 years of age. In subjects 1
to 5 years of age, the most common
adverse reactions (rate ≥2% and >placebo) were pyrexia, diarrhea,
vomiting, and otitis media. In subjects
6 to 11 months of age, the most common adverse reactions (rate ≥3%
and >placebo) were diarrhea and
constipation (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PADAGIS AT
1-866-634-9120 OR FDA AT 1-
1
The relief of symptoms associated with perennial allergic rhinitis
(1.1)
The treatment of the uncomplicated skin manifestations of chronic
idiopathic urticaria (1.2)
Children 6 months to 2 years of age: 1.25 mg (1/2 teaspoon oral
solution) (2.5mL) once daily in the
evening
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
Immedia