מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)
Aurobindo Pharma Limited
MONTELUKAST SODIUM
MONTELUKAST 10 mg
ORAL
PRESCRIPTION DRUG
Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in 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. 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 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. Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always pred
Montelukast Sodium Tablets, 10 mg are beige, rounded square shaped, film-coated tablets debossed with ‘X’ on one side and ‘54’ on other side. Bottles of 30 NDC 65862-574-30 Bottles of 90 NDC 65862-574-90 Bottles of 10000 NDC 65862-574-19 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-574-10 Storage 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 Store bottles of 10000 at 20° to 25°C (68° to 77°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.
Abbreviated New Drug Application
MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, FILM COATED AUROBINDO PHARMA LIMITED ---------- 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 TABLETS. MONTELUKAST SODIUM 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: 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 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 10 mg film-coated tablets 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 corticosteroids (5.2). Patients with known aspirin sensitivity should continue to קרא את המסמך השלם