البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)
NCS HealthCare of KY, Inc dba Vangard Labs
MONTELUKAST SODIUM
MONTELUKAST 10 mg
ORAL
PRESCRIPTION DRUG
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 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. 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, monte
Montelukast sodium tablets are available as: 10 mg (montelukast) – beige, round, film-coated tablets, debossed with “TV” on one side of the tablet and “7426” on the other side, in blistercards of 30 and 15. Montelukast sodium chewable tablets are available as: 4 mg (montelukast) – mottled pink, arc triangle-shaped tablets, debossed with “TV” on one side of the tablet and “7424”on the other side. 5 mg (montelukast) – mottled pink, square-shaped tablets, debossed with “TV” on one side of the tablet and “7425” on the other side. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Storage for Bulk Bottles When product container is subdivided, repackage into a well-closed, light-resistant container. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Abbreviated New Drug Application
MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- 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 CHEWABLE TABLETS FOR ORAL USE INITIAL U.S. APPROVAL: 1998 RECENT MAJOR CHANGES Warnings and Precautions Neuropsychiatric Events (5.4) 03/2013 Eosinophilic Conditions (5.5) 06/2013 INDICATIONS AND USAGE Montelukast sodium is 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 15 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): Asthma (2.1): Once daily in the evening for patients 2 years 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 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. 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) Montelukast sodium chewable tablets, 4 mg (montelukast) and 5 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 medic اقرأ الوثيقة كاملة