MONTELUKAST SODIUM tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

MONTELUKAST SODIUM

Composition:

MONTELUKAST 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Montelukast sodium tablets, chewable tablets and oral granules are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. Montelukast sodium tablets and chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. Montelukast sodium tablets, chewable tablets and oral granules are 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

Product summary:

Montelukast sodium Tablets 10-mg, are beige colored, film-coated tablets, circular, biconvex tablets, with code 'MO1' engraved on one side and plain on the other side. They are supplied as follows: NDC 63187-692-30 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister NDC 63187-692-60 unit of use high-density polyethylene (HDPE) bottles of 60 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister NDC 63187-692-90 high-density polyethylene (HDPE) bottles of 1000 with a polypropylene continuous threaded cap, an aluminum foil induction seal, and silica gel canister Storage Store montelukast sodium 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, COATED
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM TABLETS, CHEWABLE
TABLETS AND ORAL GRANULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR MONTELUKAST SODIUM
TABLETS, CHEWABLE TABLETS AND ORAL GRANULES.
MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions
Eosinophilic Conditions (5.5) 06/2013
INDICATIONS AND USAGE
Montelukast sodium tablets, chewable tablets, and oral granules are 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). For oral granules: Must
administer within 15 minutes after opening the sachet (with or without
mixing with food) (2.5).
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): 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 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 or one sachet of 4-mg oral
granules.
6 to 23 mont