SINGULAIR- montelukast sodium tablet, chewable SINGULAIR- 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:

Physicians Total Care, Inc.

INN (International Name):

montelukast sodium

Composition:

montelukast 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SINGULAIR® is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. SINGULAIR is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. SINGULAIR 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. 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, SINGULAIR 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

Product summary:

SINGULAIR Tablets, 4 mg, are pink, oval, bi-convex-shaped chewable tablets, with code MRK 711 on one side and SINGULAIR on the other. They are supplied as follows: SINGULAIR Tablets, 5 mg, are pink, round, bi-convex-shaped chewable tablets, with code MRK 275 on one side and SINGULAIR on the other. They are supplied as follows: SINGULAIR Tablets, 10 mg, are beige, rounded square-shaped, film-coated tablets, with code MRK 117 on one side and SINGULAIR on the other. They are supplied as follows: Storage Store SINGULAIR 4-mg oral granules, 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 SINGULAIR 5-mg chewable tablets and SINGULAIR 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.

Authorization status:

New Drug Application

Summary of Product characteristics

SINGULAIR - MONTELUKAST SODIUM TABLET, CHEWABLE
SINGULAIR - MONTELUKAST SODIUM TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SINGULAIR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SINGULAIR.
SINGULAIR (MONTELUKAST SODIUM) TABLETS, CHEWABLE TABLETS, AND ORAL
GRANULES
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
SINGULAIR is a leukotriene receptor antagonist indicated for:
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 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 6 months of age and
older (1.3).
DOSAGE AND ADMINISTRATION
Administration (by indications):
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 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 6 months
and older.
Dosage (by age):
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 packet of 4-mg oral
granules.
6 to 23 months: one packet of 4-mg oral granules.
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 packet (with or without
mixing with food) (2.5).
DOSAGE FORMS AND STRENGTHS
SINGULAIR 10-mg Film-Coated Tablets
SINGULAIR 5-mg and 4-mg Chewable Tablets
SINGULAIR 4-mg Oral Granules
CONTRAINDICATIONS
Hypersensitivity to any component of this product (4).
WARNINGS AND PRECAUTIONS
Do not prescribe SINGULAIR to treat an acute asthma attac