MONTELUKAST SODIUM tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

BluePoint Laboratories

INN (Nome Internazionale):

MONTELUKAST SODIUM

Composizione:

MONTELUKAST 10 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 mark

Dettagli prodotto:

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 68001-248-04 Bottles of 90 tablets NDC 68001-248-05 Bottles of 500 tablets NDC 68001-248-03 Store montelukast sodium 10 mg film-coated tablets at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED
BLUEPOINT LABORATORIES
----------
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, 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 tablets are a leukotriene receptor antagonist
indicated for:
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).
DOSAGE AND ADMINISTRATION
Administration (by indications):
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.
Dosage (by age) ( 2):
15 years and older: one 10 mg 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 (10.4 mg montelukast sodium
equivalent to 10 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. Do not abruptly
substitute montelukast sodium for inhaled or oral
cortic