MONTELUKAST SODIUM tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Carilion Materials Management

INN (Kansainvälinen yleisnimi):

MONTELUKAST SODIUM

Koostumus:

MONTELUKAST 10 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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. 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. Pregnancy Category B: 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 Teratogenic E

Tuoteyhteenveto:

NDC:68151-3498-2 in a CUP of 1 TABLET, FILM COATEDS

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED
CARILION MATERIALS MANAGEMENT
----------
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 MONTELUKAST CHEWABLE TABLETS, FOR ORAL
USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions
Eosinophilic Conditions ( ) 06/2013 5.5
INDICATIONS AND USAGE
Montelukast sodium tablets are 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 2years of age and older
( ). 1.3
DOSAGE AND ADMINISTRATION
Administration (by indications):
Asthma ( ): Once daily in the evening for patients 2 years and older.
2.1
Acute prevention of EIB ( ): One tablet at least 2 hours before
exercise for patients 6 years of age and older. 2.2
Seasonal allergic rhinitis ( ): Once daily for patients 2 years and
older. 2.3
Perennial allergic rhinitis ( ): Once daily for patients 2 years and
older. 2.3
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 Chewable Tablets, 4 mg and 5 mg
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