MONTELUKAST SODIUM tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)

Disponível em:

Hangzhou Minsheng Binjiang Pharm

DCI (Denominação Comum Internacional):

MONTELUKAST SODIUM

Composição:

MONTELUKAST 10 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.. Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. Because the benefits of Montelukast sodium tablet may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see Warnings and Precautions (5.1)], reserve use for patients who have an inadequate response or intolerance to alternative therapies. - Hypersensitivity to any component of this product. Risk Summary Available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [see Data]. In

Resumo do produto:

Montelukast Sodium Tablets, 10 mg, are yellow, round, film-coated tablets debossed with 10 on one side and plain on the other. They are supplied as follows: Bottles of 30: NDC 60723-010-03 Bottles of 90: NDC 60723-010-09 Bottles of 500: NDC 60723-010-50 Storage Store Montelukast Sodium 10-mg film-coated tablets at 20°C to 25°C (68°F to 77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Storage Store montelukast sodium 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET
HANGZHOU MINSHENG BINJIANG PHARM
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MONTELUKAST
SODIUM TABLETS.
MONTELUKAST SODIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
Serious neuropsychiatric events have been reported in patients taking
Montelukast Sodium ( 5.1).
Discuss benefits and risks of Montelukast Sodium with patients and
caregivers ( 5.1).
Monitor for neuropsychiatric symptoms in patients taking Montelukast
Sodium ( 5.1).
Discontinue Montelukast Sodium immediately if neuropsychiatric
symptoms occur ( 5.1).
Because the benefits of Montelukast Sodium may not outweigh the
potential risk of neuropsychiatric symptoms
in patients with allergic rhinitis, reserve use for patients who have
an inadequate response or intolerance to
alternative therapies ( 1.3, 5.1).
INDICATIONS AND USAGE
Montelukast sodium is a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 12 months of
age and older ( 1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in
patients 6 years of age and older ( 1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic
rhinitis (SAR) in patients 2 years of age and older, and
perennial allergic rhinitis (PAR) in patients 6 months of age and
older. Reserve use for patients who have an inadequate
response or intolerance to alternative therapies. ( 1.3).
DOSAGE AND ADMINISTRATION
Administration (by indications):
Asthma ( 2.1): Once daily in the evening for patients 12 months and
older.
Acute prevention of EIB ( 2.2): One tablet at least 2 hours before
exercise for patients 6 years of age and older.
Seasonal allergic rhinitis ( 2.3): Once daily for patients 2 years and
older.
Perennial allergic rhinitis ( 2.3): Once