MONTELUKAST SODIUM- montelukast sodium tablet, film coated

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Glenmark Pharmaceuticals Inc., USA

INN:

MONTELUKAST SODIUM

composition:

MONTELUKAST 10 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and adolescent patients 15 years of age and older. Montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. Montelukast sodium tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years 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, montelukast sodium should be used during pregnancy only if clearly needed. 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,

leaflet_short:

Montelukast sodium tablets, 10 mg (10.4 mg montelukast sodium equivalent to 10 mg montelukast), are round, beige colored, biconvex film coated tablets engraved with G on one side and 392 on other side. They are supplied as follows: Bottles of 30 tablets NDC 68462-392-30 Bottles of 90 tablets NDC 68462-392-90 Bottles of 500 tablets NDC 68462-392-05 Store montelukast sodium 10 mg film-coated tablets at 20° to 25°C (68° to 77°F), excursions permitted to 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

SPC

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED
GLENMARK PHARMACEUTICALS INC., USA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MONTELUKAST SODIUM
TABLETS.
MONTELUKAST SODIUM TABLETS
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions, Neuropsychiatric Events (5.4) 12/2016
INDICATIONS AND USAGE
Montelukast sodium tablets are a leukotriene receptor antagonist
indicated for:
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DOSAGE AND ADMINISTRATION
Administration (by indications):
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Dosage (by age) (2):
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Patients with both asthma and allergic rhinitis should take only one
dose daily in the evening (2.4).
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (incidence ≥5% and greater than
placebo listed in descending order of frequency): upper
respiratory infection, fever, headache, pharyngitis, cough, abdominal
pain, diarrhea, otitis media, influenza, rhinorrhea,
sinusitis, otitis (6.1).
Prophylaxis and chronic treatment of asthma in patients 15 years 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 15 years of age and older, and
perennial allergic rhinitis (PAR) in patients 15 years of age and
older (1.3).
Asthma (2.1): Once daily in the evening for patients 15 years of age
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 15 years and
older.
Perennial allergic rhinitis (2.3): Once daily for patients 15 years of
age and older.
15 years and older: one 10 mg tablet.
Montelukast sodium tablets 10 mg (10.4 mg montelukast sodium
equivalent to 10 mg m