MONTELUKAST SODIUM tablet, chewable 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:

ACETRIS HEALTH, LLC

INN (International Name):

MONTELUKAST SODIUM

Composition:

MONTELUKAST 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 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 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 market

Product summary:

Montelukast Sodium Tablets: Montelukast Sodium Tablets, 10 mg are beige, rounded square shaped, film-coated tablets debossed with ‘X’ on one side and ‘54’ on other side. Bottles of 30                     NDC 52343-037-30 Bottles of 90                     NDC 52343-037-90 Bottles of 1,000                NDC 52343-037-99 Montelukast Sodium Chewable Tablets: Montelukast Sodium Chewable Tablets, 4 mg are pink colored, oval, biconvex, uncoated tablets debossed with ‘X’ on one side and ‘52’ on other side. The tablets may be mottled. Bottles of 30                     NDC 52343-035-30 Bottles of 90                     NDC 52343-035-90 Bottles of 500                   NDC 52343-035-05 Montelukast Sodium Chewable Tablets, 5 mg are pink colored, round, biconvex, uncoated tablets debossed with ‘X’ on one side and ‘53’ on other side. The tablets may be mottled. Bottles of 30                     NDC 52343-036-30 Bottles of 90                     NDC 52343-036-90 Bottles of 500                   NDC 52343-036-05 Storage Store montelukast 4 mg chewable tablets, 5 mg chewable tablets and montelukast 10 mg film-coated tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Storage for Bulk Bottles Store bottles of 10,000 montelukast 10 mg film-coated tablets and 500 montelukast 4 mg, 5 mg chewable tablets at 20° to 25°C (68° to 77°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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, CHEWABLE
MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, FILM COATED
ACETRIS HEALTH, LLC
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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 CHEWABLE TABLETS, FOR ORAL USE 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 is 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 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 2 years of age and 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): 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 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 10 mg Film-Coated Tablets
Montelukast Sodium 5 mg and 4 mg Chewable Tablets
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