MONTELUKAST SODIUM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

INN (International Name):

MONTELUKAST SODIUM

Composition:

MONTELUKAST 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Montelukast sodium tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older. Montelukast sodium tablet is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. Montelukast sodium tablet is 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. 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

Product summary:

Montelukast Sodium Tablets 10 mg, are beige colored, rounded square, biconvex, film coated tablet debossed M10 on one side and plain on other side. NDC 68071-4047-3 Bottles of 30 Storage Store 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 package.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED
NUCARE PHARMACEUTICALS,INC.
----------
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, 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 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 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
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 Film-Coated Tablets, 10 mg ( 3)
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 sensiti