MONTELUKAST SODIUM tablet, film coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Aidarex Pharmaceuticals LLC

INN (Међународно име):

MONTELUKAST SODIUM

Састав:

MONTELUKAST 10 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and adolescent patients 15 years of age and older. Montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp’s montelukast tablet products. However, due to Merck Sharp & Dohme Corp’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Montelukast sodium tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older. Hypersensitivity to any component of this product. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predi

Резиме производа:

Montelukast sodium tablets, 10 mg (10.4 mg montelukast sodium equivalent to 10 mg montelukast), are round, beige colored, biconvex film coated tablets engraved with G on one side and 392 on other side. They are supplied as follows: Bottles of 30 tablets NDC 33261-0969-30 Bottles of 90 tablets NDC 33261-0969-90 Store montelukast sodium 10 mg film-coated tablets 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]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light-resistant container.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED
AIDAREX PHARMACEUTICALS LLC
----------
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
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Montelukast sodium tablets are a leukotriene receptor antagonist
indicated for:
•Prophylaxis and chronic treatment of asthma in patients 15 years of
age and older (1.1).
•Acute prevention of exercise-induced bronchoconstriction (EIB) in
patients 15 years of age and older (1.2).
•Relief of symptoms of allergic rhinitis (AR): seasonal allergic
rhinitis (SAR) in patients 15 years of age and older, and
perennial allergic rhinitis (PAR) in patients 15 years of age and
older (1.3).
DOSAGE AND ADMINISTRATION
Administration (by indications):
•Asthma (2.1): Once daily in the evening for patients 15 years of
age and older.
•Acute prevention of EIB (2.2): 10 mg tablet at least 2 hours before
exercise for patients 15 years of age and older.
•Seasonal allergic rhinitis (2.3): Once daily for patients 15 years
and older.
•Perennial allergic rhinitis (2.3): Once daily for patients 15 years
of age and older.
Dosage (by age) (2):
•15 years and older: one 10 mg tablet.
Patients with both asthma and allergic rhinitis should take only one
dose daily in the evening (2.4).
DOSAGE FORMS AND STRENGTHS
•Montelukast sodium tablets 10 mg (10.4 mg montelukast sodium
equivalent to 10 mg montelukast)
CONTRAINDICATIONS
•Hypersensitivity to any component of this product (4).
WARNINGS AND PRECAUTIONS
•Do not prescribe montelukast sodium to treat an acute asthma attack
(5.1).
•Advise patients to have appropriate rescue medication available
(5.1).
•Inhaled corticosteroid may be reduced gradually. Do not abruptly
substitute montelukast sodium for inhaled or oral
corticosteroids (5.2).
•Patients with known aspirin sensitivity should co