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:

REMEDYREPACK INC.

INN (International Name):

MONTELUKAST SODIUM

Composition:

MONTELUKAST 10 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 12 months 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 6 months of age and older.  - Hypersensitivity to any component of this product. Risk Summary Available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [ see Data ]. In animal reproduction studies, no adverse developmental effects were observed with oral administration of montelukast to pregnant rats and rabbits during organogenesis at doses approximately 100 and 110 times, respectively, the maximum recomme

Product summary:

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: 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: 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: 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED
REMEDYREPACK INC.
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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 TABLETS, FOR ORAL USE
MONTELUKAST SODIUM CHEWABLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions,
Neuropsychiatric Events ( 5.4)
12/2018
INDICATIONS AND USAGE
Montelukast sodium tablets 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 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).
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 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.
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 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).
Inhaled corticosteroid may