MONTELUKAST SODIUM tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

DIRECT RX

INN (International Name):

MONTELUKAST SODIUM

Sammensetning:

MONTELUKAST 10 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

1.1 Asthma Montelukast sodium tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium tablet is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp’s montelukast tablet products. However, due to Merck Sharp & Dohme Corp’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.3 Allergic Rhinitis Montelukast sodium tablet is 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 8.1 Pregnancy Pregnancy Category B: There are no adequat

Produkt oppsummering:

Montelukast Sodium Tablets 10 mg, are beige colored, rounded square, biconvex, film coated tablet debossed “M10” on one side and plain on other side. They are supplied as follows: NDC 16729-119-10 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant. NDC 16729-119-15 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant. NDC 16729-119-17 high-density polyethylene (HDPE) bottles of 1000 with a polypropylene non child-resistant cap, an aluminum foil induction seal, and silica gel desiccant. Storage Store montelukast sodium 10 mg film-coated tablets at 25°C (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 package.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED
DIRECT RX
----------
MONTELUKAST SODIUM
INDICATIONS & USAGE SECTION
1.1 Asthma
Montelukast sodium tablet is indicated for the prophylaxis and chronic
treatment of
asthma in adults and pediatric patients 15 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium tablet is indicated for prevention of
exercise-induced
bronchoconstriction (EIB) in patients 15 years of age and older.
Pediatric use information for patients ages 6 to 14 years of age for
acute prevention of
exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp
& Dohme
Corp’s montelukast tablet products. However, due to Merck Sharp &
Dohme Corp’s
marketing exclusivity rights, this drug product is not labeled with
that pediatric
information.
1.3 Allergic Rhinitis
Montelukast sodium tablet is 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.
DOSAGE & ADMINISTRATION SECTION
2.1 Asthma
Montelukast sodium tablets should be taken once daily in the evening.
The following
doses are recommended:
For adults and adolescents 15 years of age and older: one 10-mg
tablet.
Safety and effectiveness in pediatric patients less than 12 months of
age with asthma
have not been established.
There have been no clinical trials in patients with asthma to evaluate
the relative efficacy
of morning versus evening dosing. The pharmacokinetics of montelukast
are similar
whether dosed in the morning or evening. Efficacy has been
demonstrated for asthma
when montelukast was administered in the evening without regard to
time of food
ingestion.
2.2 Exercise-Induced Bronchoconstriction (EIB) in Patients 15 Years of
Age and Older
For prevention of EIB, a single 10 mg dose of montelukast should be
taken at least 2
hours before exercise. An additional dose of montelukast should not be
taken within 24
hours of a previous dose. Patients already taking monteluk