Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)
Proficient Rx LP
MONTELUKAST SODIUM
MONTELUKAST 4 mg
ORAL
PRESCRIPTION DRUG
Montelukast sodium tablets, chewable tablets and oral granules are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. Montelukast sodium tablets and chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. Montelukast sodium tablets, chewable tablets and oral granules are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. 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
Montelukast sodium Chewable Tablets 4-mg are pink colored, slightly mottled, circular, biconvex, uncoated tablets, with code 'MT1' engraved on one side and plain on the other side. They are supplied as follows: Storage Store montelukast sodium 4-mg oral granules, 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.
Abbreviated New Drug Application
MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, CHEWABLE PROFICIENT RX LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES. MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES INITIAL U.S. APPROVAL: 1998 RECENT MAJOR CHANGES Warnings and Precautions Eosinophilic Conditions (5.5) 06/2013 INDICATIONS AND USAGE Montelukast sodium tablets, chewable tablets, and oral granules are 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). For oral granules: Must administer within 15 minutes after opening the sachet (with or without mixing with food) (2.5). DOSAGE FORMS AND STRENGTHS • • • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • Prophylaxis and chronic treatment of asthma in patients 12 months 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 6 months of age and older (1.3). Asthma (2.1): Once daily in the evening for patients 12 months 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 6 months 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 or one sachet of 4-mg oral granules. 6 to 23 mo Прочитајте комплетан документ