MONTELUKAST SODIUM- montelukast sodium tablet, film coated

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

REMEDYREPACK INC.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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. 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 recommended human daily oral dose (MRHDOD) b

Vörulýsing:

Montelukast Sodium Tablets USP are available as: 10 mg (montelukast) – beige, standard convex round, film-coated tablets, debossed with “TV” on one side of the tablet and “7426” on the other side, in bottles of 30 (NDC 0093-7426-56), 90 (NDC 0093-7426-98), and 1000 (NDC 0093-7426-10). Montelukast Sodium Chewable Tablets USP 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 bottles of 30 (NDC 0093-7424-56) and 90 (NDC 0093-7424-98). 5 mg (montelukast) – mottled pink, square-shaped tablets, debossed with “TV” on one side of the tablet and “7425” on the other side, in bottles of 30 (NDC 0093-7425-56) and 90 (NDC 0093-7425-98). 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). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

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 AND 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 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 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 gra