Страна: САЩ
Език: английски
Източник: 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 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. 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) ba
Montelukast Sodium Chewable Tablets, USP, 4-mg (montelukast), are pink, oval-shaped chewable tablets, debossed with E223 on one side and plain on the other. They are supplied as follows: NDC 0603-4653-16 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4653-02 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4653-28 bulk packaging high-density polyethylene (HDPE) bottles of 500 with a polypropylene cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4653-32 bulk packaging high-density polyethylene (HDPE) bottles of 1,000 with a polypropylene cap, an aluminum foil induction seal, and silica gel desiccant Montelukast Sodium Chewable Tablets, USP, 5-mg (montelukast), are pink, round-shaped chewable tablets, debossed with E224 on one side and plain on the other. They are supplied as follows: NDC 0603-4654-16 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4654-02 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4654-28 bulk packaging high-density polyethylene (HDPE) bottles of 500 with a polypropylene cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4654-32 bulk packaging high-density polyethylene (HDPE) bottles of 1,000 with a polypropylene cap, an aluminum foil induction seal, and silica gel desiccant Montelukast Sodium Film-Coated Tablets, USP, 10 mg (montelukast) are round-shaped, beige tablets, debossed with E225 on one side and plain on the other. They are supplied as follows: NDC 0603-4655-16 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4655-02 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4655-28 bulk packaging high-density polyethylene (HDPE) bottles of 500 with a polypropylene cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4655-32 bulk packaging high-density polyethylene (HDPE) bottles of 1,000 with a polypropylene cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4655-34 bulk packaging high-density polyethylene (HDPE) bottles of 5,000 with a polypropylene cap, an aluminum foil induction seal, and silica gel desiccant Storage Store montelukast 4-mg chewable tablets, 5-mg chewable tablets and 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.
Abbreviated New Drug Application
MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MONTELUKAST SODIUM TABLETS AND MONTELUKAST SODIUM CHEWABLE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MONTELUKAST SODIUM TABLETS AND MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST SODIUM TABLETS AND 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 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 Film-Coated Tablets, 10 mg Montelukast sodium Chewable Tablets, 4 mg and 5 mg 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 Прочетете целия документ