LEVOCETIRIZINE DIHYDROCHLORIDE tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Preferred Pharmaceuticals, Inc.

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 years of age and older. Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. The use of levocetirizine dihydrochloride tablets are 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 (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 insufficient

Produktu pārskats:

Levocetirizine dihydrochloride tablets, USP are white to off white, oval shaped biconvex, film-coated tablet debossed with 'I' and '12' on one side and score line on the other side and contain 5 mg levocetirizine dihydrochloride. They are supplied in Storage: Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86°F) [see USP Controlled Room Temperature].

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET,
FILM COATED
PREFERRED PHARMACEUTICALS, 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 is a histamine H
-receptor antagonist indicated for:
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DOSAGE AND ADMINISTRATION
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
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•
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WARNINGS AND PRECAUTIONS
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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
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)
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
Immediate release breakable (scored) tablets, 5 mg ( 3)
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)
Avoid engaging in hazardous occupations requiring complete mental
al