MONTELUKAST SODIUM- montelukast sodium tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

Montelukast Sodium

구성:

Montelukast 10 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Montelukast sodium Chewable Tablets, 4-mg, are round, light pink, convex tablets, debossed with "KU" on one side and "204" on the other. They are supplied as follows: NDC 42291-622-30 Bottles of 30 NDC 42291-622-90 Bottles of 90 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 42291-623-30 Bottles of 30 NDC 42291-623-90 Bottles of 90 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: NDC 42291-621-30 Bottles of 30 NDC 42291-621-90 Bottles of 90 NDC 42291-621-10 Bottles of 1000 NDC 42291-621-55 Bottles of 5000 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.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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---------------
WARNINGS AND PRECAUTIONS NEUROPSYCHIATRIC EVENTS (5.4) 03/2013
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 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 medication available (5.1).
Inhaled corticosteroid may be reduced