Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)
REMEDYREPACK INC.
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. 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 110 times, respectively, the maximum recommended human daily oral dose (MRHDOD)
Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-725-30 Bottles of 90 NDC 55111-725-90 Bottles of 100 NDC 55111-725-01 Bottles of 1000 NDC 55111-725-10 Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-593-30 Bottles of 90 NDC 55111-593-90 Bottles of 500 NDC 55111-593-05 Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-594-30 Bottles of 90 NDC 55111-594-90 Bottles of 500 NDC 55111-594-05 Unit Dosage Package of 100 (10x10) NDC 55111-594-78 Storage Store montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.
Abbreviated New Drug Application
MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, COATED REMEDYREPACK INC. ---------- 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 INITIAL U.S. APPROVAL: 1998 RECENT MAJOR CHANGES Warnings and Precautions, Neuropsychiatric Events ( 5.4) 12/2018 INDICATIONS AND USAGE Montelukast sodium tablets are 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 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 (montelukast) Film-Coated Tablets (3) • Montelukast sodium 5 mg and 4 mg (montelukast) Chewable Tablets (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 medicatio Les hele dokumentet