Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)
Proficient Rx LP
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 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
Montelukast sodium Tablets, 10-mg, are round, white, film-coated, convex tablets, debossed with "KU" on one side and "210" on the other. They are supplied as follows: NDC 63187-216-30 bottles of 30 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. Storage for Bulk Bottles Store bottles of 1000 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 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 PROFICIENT RX LP ---------- 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 tablets is a leukotriene receptor antagonist indicated for: • • • DOSAGE AND ADMINISTRATION Administration (by indications): • • • • Dosage (by age) (2): • • • Patients with both asthma and allergic rhinitis should take only one dose daily in the evening (2.4). DOSAGE FORMS AND STRENGTHS • • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • 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 or older (1.3). 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. 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 Đọc toàn bộ tài liệu