MONTELUKAST SODIUM- montelukast sodium tablet, chewable

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Preferred Pharmaceuticals Inc.

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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. 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, montelukast sodium 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 defects h

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, CHEWABLE
PREFERRED PHARMACEUTICALS 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 CHEWABLE TABLETS, FOR ORAL USE
MONTELUKAST SODIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions, Neuropsychiatric Events (5.4) 12/2016
INDICATIONS AND USAGE
Montelukast sodium is 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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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).
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.
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.
Montelukast Sodium 10 mg Film-Coated Tablets USP
Montelukast Sodium 5 mg and 4 mg Chewable Tablets USP
Hypersensitivity to any component of this product (4).
Do not prescribe montelukast sodium to treat an acute asthma attack
(5.1).
Advise patients to have appropriat