MONTELUKAST SODIUM tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

Montelukast Sodium (UNII: U1O3J18SFL) (Montelukast - UNII:MHM278SD3E)

Sẵn có từ:

Rebel Distributors Corp

INN (Tên quốc tế):

Montelukast Sodium

Thành phần:

Montelukast 10 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 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 is indicated for the relief of symptoms of seasonal 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

Tóm tắt sản phẩm:

Montelukast sodium Tablets, 10-mg, are round, white, film-coated, convex tablets, debossed with "KU" on one side and "210" on the other. They are supplied as follows: Storage Store montelukast 4-mg chewable tablets, 5-mg chewable tablets and 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. Storage for Bulk Bottles Store bottles of 1000 montelukast 4-mg chewable tablets, 5-mg chewable tablets and 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 container. When product container is subdivided, repackage into a well-closed, light-resistant container.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED
REBEL DISTRIBUTORS CORP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR MONTELUKAST SODIUM.
MONTELUKAST SODIUM TABLETS AND CHEWABLE TABLETS
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Indications and Usage Exercise-Induced
Bronchoconstriction (EIB) (1.2)
03/2012
Dosage and Administration Exercise-Induced
Bronchoconstriction (EIB) (2.2)
03/2012
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 15 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 or 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): 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 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, 4-mg and 5-mg.
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 medicati