MONTELUKAST SODIUM tablet, chewable

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:

Proficient Rx LP

INN (Tên quốc tế):

MONTELUKAST SODIUM

Thành phần:

MONTELUKAST 5 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 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.  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 marketing experience, congenital limb defects have been

Tóm tắt sản phẩm:

Montelukast sodium Chewable Tablets, 5-mg, are round, light pink, convex tablets, debossed with "KU" on one side and "205" on the other. They are supplied as follows:  NDC 63187-896-30  bottles of 30  NDC 63187-896-60  bottles of 60  NDC 63187-896-90  bottles of 90 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, CHEWABLE
PROFICIENT RX LP
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions,
Neuropsychiatric Events (5.4)
12/2016
INDICATIONS AND USAGE
Montelukast sodium tablets is a leukotriene receptor antagonist
indicated for:
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DOSAGE AND ADMINISTRATION
Administration (by indications):
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Dosage (by age) (2):
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Patients with both asthma and allergic rhinitis should take only one
dose daily in the evening (2.4).
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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 (1.3).
Asthma (2.1): Once daily in the evening for patients 12 months and
older.
Acute prevention of EIB (2.2): 10 mg 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 6 months
and older.
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.
Montelukast sodium Film-Coated Tablets, 10-mg
Montelukast sodium 5-mg and 4-mg Chewable Tablets
Hypersensitivity to any component of this product (4).
Do not prescribe montelukast sodium to treat an acute asthma attack
(5.1).
Advise patients to have appropriate rescue medication available (5.1