Country: United States
Language: English
Source: NLM (National Library of Medicine)
MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)
A-S Medication Solutions
MONTELUKAST SODIUM
MONTELUKAST 5 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 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 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 [see Nonclinical Toxicology (13.2)] . During worl
Product: 50090-2619 NDC: 50090-2619-0 30 TABLET, CHEWABLE in a BOTTLE NDC: 50090-2619-1 90 TABLET, CHEWABLE in a BOTTLE
Abbreviated New Drug Application
MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, CHEWABLE A-S MEDICATION SOLUTIONS ---------- 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 CHEWABLE TABLETS, FOR ORAL USE MONTELUKAST SODIUM TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1998 RECENT MAJOR CHANGES Warnings and Precautions, Neuropsychiatric Events (5.4) 12/2016 INDICATIONS AND USAGE Montelukast sodium is a 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: one 10 mg tablet. 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 10 mg Film-Coated Tablets USP Montelukast Sodium 5 mg and 4 mg Chewable Tablets USP 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 gradua Read the complete document