Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)
Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd.
MONTELUKAST SODIUM
MONTELUKAST 4 mg
ORAL
PRESCRIPTION DRUG
Montelukast sodium chewable tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. Montelukast sodium chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. Montelukast sodium chewable tablets 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 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 AUCs
Montelukast Sodium 5-mg Chewable Tablets are pink, capsule-shaped tablets, debossed with “5” on one side and plain on the other. They are supplied as follows: Bottles of 30: NDC 60723-005-03 Bottles of 90: NDC 60723-005-09 Bottles of 500: NDC 60723-005-50 Montelukast Sodium 4-mg Chewable Tablets are pink, capsule-shaped tablets, debossed with “4” on one side and plain on the other. They are supplied as follows: Bottles of 30: NDC 60723-004-03 Bottles of 90: NDC 60723-004-09 Bottles of 500: NDC 60723-004-50 Storage Store montelukast sodium 4-mg and 5-mg chewable 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 HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MONTELUKAST SODIUM CHEWABLE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST SODIUM CHEWABLE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1998 INDICATIONS AND USAGE Montelukast Sodium Chewable Tablets are 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 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): 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: 10 mg 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 5-mg and 4 mg Chewable 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 Прочитајте комплетан документ