LEVOCETIRIZINE DIHYDROCHLORIDE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

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Fachinformation Fachinformation (SPC)
01-10-2022

Wirkstoff:

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

Verfügbar ab:

Proficient Rx LP

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 is 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 (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, or adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm with administration of levocetirizine by the oral route to

Produktbesonderheiten:

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 the 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. 30 tablets (NDC 71205-476-30) 60 tablets (NDC 71205-476-60) 90 tablets (NDC 71205-476-90) 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].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

                                LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET
PROFICIENT RX LP
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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)
•
•
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DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
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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 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 WESTMINSTER
PHARMACEUTICALS, LLC AT
1-844-221-7294 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
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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
Adjust the dose in patients 12 years of age and older with decreased
renal function (12.3)
Immediate release breakable (functional 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 tha
                                
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