MONTELUKAST tablet, film coated MONTELUKAST tablet, chewable

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

West ward Pharmaceutical Corp

INN（国际名称）:

MONTELUKAST SODIUM

组成:

MONTELUKAST 10 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years 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 2 years of age and older. Hypersensitivity to any component of this product. Pregnancy  Category  B: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, montelukast sodium should be used during pregnancy only if clearly needed. Teratogenic  Effect: No teratogenicity was observed in rats and rabbits at doses approximately 100 and 110 times, respectively, the maximum recommended daily oral dose in adults based on AUCs [see  Nonclinical Toxicology (13.2)]. During worldwide marke

產品總結:

Montelukast sodium film-coated, 10 mg, are beige, rounded, bi-convex-shaped, debossed with "AUM101" on one side and plain on the other side. They are supplied as follows: Montelukast sodium chewable tablets, 5 mg, are pink, rounded, bi-convex-shaped, debossed with "AUM102" on one side and plain on the other side. They are supplied as follows: Montelukast sodium chewable tablets, 4 mg, are pink colored, oval, bi-convex-shaped, debossed with "AUM103" on one side and plain on the other side. They are supplied as follows: Storage Store montelukast sodium 10 mg film coated tablets, 5-mg chewable tablets and 4-mg chewable tablets at 25°C (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 package. Storage for Bulk Bottles Store bottles of 1000 montelukast sodium-10 mg film coated tablets at 25°C (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.

授权状态:

Abbreviated New Drug Application

产品特点

MONTELUKAST- MONTELUKAST TABLET, FILM COATED
MONTELUKAST- MONTELUKAST TABLET, CHEWABLE
WEST WARD PHARMACEUTICAL CORP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM TABLETS AND
MONTELUKAST SODIUM CHEWABLE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
MONTELUKAST SODIUM TABLETS AND MONTELUKAST SODIUM CHEWABLE TABLETS.
MONTELUKAST SODIUM TABLETS, FOR ORAL USE.
MONTELUKAST SODIUM CHEWABLE TABLETS, FOR ORAL USE.
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions
Eosinophilic Conditions (5.5) 06/2013
INDICATIONS AND USAGE
Montelukast sodium tablets are a leukotriene receptor antagonist
indicated for:
Prophylaxis and chronic treatment of asthma in patients 2 years 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 2 years of age and older
(1.3).
DOSAGE AND ADMINISTRATION
Administration (by indications):
Asthma (2.1): Once daily in the evening for patients 2 years 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 daily for patients 2 years and
older.
Dosage (by age) (2)
15 years and older: one 10-mg tablet.
6 to 14 years: one 5-mg chewable tablet.
2 to 5 years: one 4-mg chewable 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 Film-Coated Tablets, 10-mg
Montelukast Sodium Chewable Tablets, 5-mg and 4-mg
CONTRAINDICATIONS
Hypersensitivity to any component of this product (4).
WARNINGS AND PRECAUTIONS
Do not prescribe montelukast sodium to treat an acute ast