Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. 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 6 months of age and older. - Hypersensitivity to any component of this product. Risk Summary Available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [see Data] . In animal reproduction studies, no adverse developmental effects were observed with oral administration of montelukast to pregnant rats and rabbits during organogenesis at doses approximately 100 and 1
NDC: 71335-1326-1: 30 Tablets in a BOTTLE
Abbreviated New Drug Application
MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, CHEWABLE BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION 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, FOR ORAL USE MONTELUKAST SODIUM CHEWABLE TABLETS, FOR ORAL USE AND MONTELUKAST SODIUM ORAL GRANULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1998 RECENT MAJOR CHANGES Warnings and Precautions, Neuropsychiatric Events ( 5.4) 08/2019 INDICATIONS AND USAGE Montelukast sodium is a leukotriene receptor antagonist indicated for: 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). DOSAGE AND ADMINISTRATION Administration (by indications): 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. 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 or one packet of 4-mg oral granules. 6 to 23 months: one packet of 4-mg oral granules. 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 packet (with or without mixing with food) ( 2.5). DOSAGE FORMS AND STRENGTHS Montelukast sodium Film-coated Tablets, 10 mg Montelukast sodium Chewable Tablets, 4 Διαβάστε το πλήρες έγγραφο