MONTELUKAST SODIUM- montelukast sodium tablet, chewable

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

NuCare Pharmaceuticals,Inc.

INN (Nome Internazionale):

MONTELUKAST SODIUM

Composizione:

MONTELUKAST 4 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

            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

Dettagli prodotto:

Montelukast sodium chewable tablets, 4 mg, are pink colored, oval biconvex shaped, uncoated tablets, debossed with 1079 on one side and 4 MG on other side. They are supplied as follows: NDC 68071-4054-9 Bottles of 90 Storage Store montelukast sodium 4-mg (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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, CHEWABLE
NUCARE 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 TABLETS, FOR ORAL USE AND
MONTELUKAST SODIUM 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: (1)
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).
DOSAGE AND ADMINISTRATION
Administration (by indications): (2)
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.
Dosage (by age): (2)
15 years and older: one 10-mg tablet.
2 to 5 years: one 4-mg chewable tablet.
6 to 14 years: one 5-mg chewable tablet.
Patients with both asthma and allergic rhinitis should take only one
dose daily in the evening (2.4). (2)
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 m