Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)
Contract Pharmacy Services-PA
MONTELUKAST SODIUM
MONTELUKAST 10 mg
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. 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 Toxicolo
Montelukast Sodium Tablets, USP 10 mg are pale yellow colored, round, film-coated tablets with 'U' debossed on one side and '220' debossed on other side. NDC 67046-468-07 blisterpacks of 7 NDC 67046-468-14 blisterpacks of 14 NDC 67046-468-15 blisterpacks of 15 NDC 67046-468-20 blisterpacks of 20 NDC 67046-468-21 blisterpacks of 21 NDC 67046-468-28 blisterpacks of 28 NDC 67046-468-30 blisterpacks of 30 NDC 67046-468-60 blisterpacks of 60 Storage Store Montelukast Sodium Tablets at 20 0 to 25 0 C (68 0 to 77 0 F) [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Storage for Bulk Bottles Store bottles of 1000, Montelukast Sodium Tablets at 20 0 to 25 0 C (68 0 to 77 0 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 CONTRACT PHARMACY SERVICES-PA ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION 468 MONTELUKAST 10 MG THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MONTELUKAST SODIUM TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MONTELUKAST SODIUM TABLETS USP . MONTELUKAST SODIUM TABLETS USP, FOR ORAL USE INITIAL U.S. APPROVAL: 1998 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. Patients with both asthma and allergic rhinitis should take only one dose daily in the evening ( 2.4). DOSAGE FORMS AND STRENGTHS Montelukast Sodium Tablets, USP 10 mg ( 3). 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 with known aspirin sensitivity should continue to avoid aspirin or non-steroidal anti-inflammat Les hele dokumentet