MONTELUKAST SODIUM- montelukast sodium tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Major Pharmaceuticals

INN (Medzinárodný Name):

MONTELUKAST SODIUM

Zloženie:

MONTELUKAST 10 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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. 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

Prehľad produktov:

Montelukast Sodium Tablets, 10 mg (montelukast) are round-shaped, beige tablets, debossed with E225 on one side and plain on the other.  They are supplied as follows: 100 tablets in unit dose blisters per box NDC 0904-6529-61  (10 cards of 10 tablets each) Storage Store montelukast 4-mg chewable tablets, 5-mg chewable tablets and 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED
MAJOR PHARMACEUTICALS
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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 TABLETS AND MONTELUKAST CHEWABLE TABLETS, FOR ORAL
USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions
Eosinophilic Conditions (5.5) 06/2013
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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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).
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 Film-Coated Tablets, 10 mg
Montelukast sodium Chewable Tablets, 4 mg and 5 mg
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 appropriate rescue medication av