Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)
Glenmark Pharmaceuticals Inc., USA
MONTELUKAST SODIUM
MONTELUKAST 10 mg
ORAL
PRESCRIPTION DRUG
Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and adolescent 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. 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. 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. 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 [see Nonclinical Toxicology (13.2)]. During worldwide marketing experience,
Montelukast sodium tablets, 10 mg (10.4 mg montelukast sodium equivalent to 10 mg montelukast), are round, beige colored, biconvex film coated tablets engraved with G on one side and 392 on other side. They are supplied as follows: Bottles of 30 tablets NDC 68462-392-30 Bottles of 90 tablets NDC 68462-392-90 Bottles of 500 tablets NDC 68462-392-05 Store montelukast sodium 10 mg film-coated tablets at 20° to 25°C (68° to 77°F), excursions permitted to 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 GLENMARK PHARMACEUTICALS INC., USA ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MONTELUKAST SODIUM TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM TABLETS INITIAL U.S. APPROVAL: 1998 RECENT MAJOR CHANGES Warnings and Precautions, Neuropsychiatric Events (5.4) 12/2016 INDICATIONS AND USAGE Montelukast sodium tablets 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). DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • • ADVERSE REACTIONS Most common adverse reactions (incidence ≥5% and greater than placebo listed in descending order of frequency): upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis (6.1). 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). 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 of age and older. 15 years and older: one 10 mg tablet. Montelukast sodium tablets 10 mg (10.4 mg montelukast sodium equivalent to 10 mg m Pročitajte cijeli dokument