LEVOCETIRIZINE DIHYDROCHLORIDE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

AvKARE, Inc.

DCI (Denominação Comum Internacional):

LEVOCETIRIZINE DIHYDROCHLORIDE

Composição:

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

1.2 Perennial Allergic Rhinitis Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months of age and older. The use of levocetirizine dihydrochloride tablet is contraindicated in: 4.1 Patients with known hypersensitivity 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)]. 4.2 Patients with end-stage renal disease Patients with end-stage renal disease (CLCR < 10 mL/min) and patients undergoing hemodialysis 4.3 Pediatric patients with impaired renal function Children 6 months to 11 years of age with impaired renal function 8.1 Pregnancy Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictiv

Resumo do produto:

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 bisect and other side “1” on the left side and “36” on the right side of the bisect. They are supplied in bottles of 90 tablets (NDC 42291-386-90) 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].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET
AVKARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS, USP
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
RECENT MAJOR CHANGES
Dosage and Administration (2.2) 02/2017
INDICATIONS AND USAGE
Levocetirizine dihydrochloride tablets are a histamine H1-receptor
antagonist indicated for: (1)
The treatment of the uncomplicated skin manifestations of chronic
idiopathic urticaria (1.2) (1)
DOSAGE AND ADMINISTRATION
• Adults and children 12 years of age and older: 5 mg once daily in
the evening (2.1)
• Children 6 to 11 years of age: 2.5 mg once daily in the evening
(2.2)
• Renal Impairment
Adjust the dose in patients 12 years of age and older with decreased
renal function (2.4, 12.3) (2)
DOSAGE FORMS AND STRENGTHS
• Immediate release breakable (functional scored) tablets, 5 mg (3)
(3)
CONTRAINDICATIONS
• 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)
(4)
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 system
depressants with levocetirizine
dihydrochloride (5.1).
• Use with caution in patients with predisposing factors of urinary
retention (e.g. spinal cord lesion,
prostatic hyperplasia). Discontinue levocetirizine dihydrochloride if
urinary retention occurs (5.2).
(