MONTELUKAST SODIUM tablet, film coated MONTELUKAST SODIUM tablet, chewable

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Physicians Total Care, Inc.

INN:

MONTELUKAST SODIUM

composition:

MONTELUKAST 10 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 15 years of age and older. Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp’s montelukast tablet products. However, due to Merck Sharp & Dohme Corp’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, mo

leaflet_short:

Montelukast sodium tablets are available as: 10 mg (montelukast) – beige, round, film-coated tablets, debossed with “TV” on one side of the tablet and “7426” on the other side, in Montelukast sodium chewable tablets are available as: 4 mg (montelukast) – mottled pink, arc triangle-shaped tablets, debossed with “TV” on one side of the tablet and “7424”on the other side, in 5 mg (montelukast) – mottled pink, square-shaped tablets, debossed with “TV” on one side of the tablet and “7425” on the other side, in Store 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 When product container is subdivided, repackage into a well-closed, light-resistant container. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

authorization_status:

Abbreviated New Drug Application

SPC

MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, FILM COATED
MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, CHEWABLE
PHYSICIANS TOTAL CARE, 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 AND CHEWABLE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Montelukast sodium 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) (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)
Montelukast sodium chewable tablets, 4 mg (montelukast) and 5 mg
(montelukast)
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. D