Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)
Organon LLC
ORAL
PRESCRIPTION DRUG
SINGULAIR® is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. SINGULAIR is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. SINGULAIR 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. Because the benefits of SINGULAIR may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see Warnings and Precautions (5.1)] , reserve use for patients who have an inadequate response or intolerance to alternative therapies. SINGULAIR is not indicated for the treatment of an acute asthma attack. SINGULAIR is contraindicated in patients with hypersensitivity to any of its components. Risk Summary Available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not estab
SINGULAIR 4 mg Oral Granules: white granules with 500 mg net weight, packed in a child-resistant foil packet. NDC 78206-171-01 unit of use carton with 30 packets. SINGULAIR 4 mg Tablets: pink, oval, bi-convex-shaped chewable tablets, with code MSD 711 on one side and SINGULAIR on the other. NDC 78206-170-01 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. SINGULAIR 5 mg Tablets: pink, round, bi-convex-shaped chewable tablets, with code MSD 275 on one side and SINGULAIR on the other. NDC 78206-173-01 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. SINGULAIR 10 mg Tablets: beige, rounded square-shaped, film-coated tablets, with code MSD 117 on one side and SINGULAIR on the other. NDC 78206-172-01 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 78206-172-02 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. Storage Store SINGULAIR 4-mg oral granules, 4-mg chewable tablets, 5-mg chewable tablets and 10-mg film-coated tablets at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.
New Drug Application
SINGULAIR- MONTELUKAST SODIUM TABLET, CHEWABLE SINGULAIR- MONTELUKAST SODIUM TABLET, FILM COATED Organon LLC ---------- MEDICATION GUIDE SINGULAIR® (SING-U-LAIR) (MONTELUKAST SODIUM) TABLETS CHEWABLE TABLETS ORAL GRANULES This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 6/2021 What is the most important information I should know about SINGULAIR? Serious mental health problems have happened in people taking SINGULAIR or even after treatment has stopped. This can happen in people with or without a history of mental health problems. Stop taking SINGULAIR and tell your healthcare provider right away if you or your child have any unusual changes in behavior or thinking, including any of these symptoms: • agitation, including aggressive behavior or hostility • attention problems • bad or vivid dreams • depression • disorientation (confusion) • feeling anxious • irritability • hallucinations (seeing or hearing things that are not really there) • memory problems • obsessive-compulsive symptoms • restlessness • sleep walking • stuttering • suicidal thoughts and actions (including suicide) • tremor • trouble sleeping • uncontrolled muscle movements What is SINGULAIR? SINGULAIR is a prescription medicine that blocks substances in the body called leukotrienes. This may help to improve symptoms of asthma and inflammation of the lining of the nose (allergic rhinitis). SINGULAIR does not contain a steroid. SINGULAIR is used to: 1. Prevent asthma attacks and for the long-term treatment of asthma in adults and children ages 12 months and older. Do not take SINGULAIR if you need relief right away for a sudden asthma attack. If you have an asthma attack, you should follow the instructions your healthcare provider gave you for treating asthma attacks. 2. Prevent exercise-induced asthma in people 6 years of age and older. 3. Help control the symptoms of allergic rhinitis such as sneezing, stuffy nose, runny nose, and itching of the nose. SINGULAIR is used to Soma hati kamili
SINGULAIR- MONTELUKAST SODIUM GRANULE SINGULAIR- MONTELUKAST SODIUM TABLET, CHEWABLE SINGULAIR- MONTELUKAST SODIUM TABLET, FILM COATED ORGANON LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SINGULAIR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SINGULAIR. SINGULAIR (MONTELUKAST SODIUM) TABLETS, FOR ORAL USE SINGULAIR (MONTELUKAST SODIUM) CHEWABLE TABLETS, FOR ORAL USE SINGULAIR (MONTELUKAST SODIUM) ORAL GRANULES INITIAL U.S. APPROVAL: 1998 WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ SERIOUS NEUROPSYCHIATRIC EVENTS HAVE BEEN REPORTED IN PATIENTS TAKING SINGULAIR (5.1). DISCUSS BENEFITS AND RISKS OF SINGULAIR WITH PATIENTS AND CAREGIVERS (5.1). MONITOR FOR NEUROPSYCHIATRIC SYMPTOMS IN PATIENTS TAKING SINGULAIR (5.1). DISCONTINUE SINGULAIR IMMEDIATELY IF NEUROPSYCHIATRIC SYMPTOMS OCCUR (5.1). BECAUSE THE BENEFITS OF SINGULAIR MAY NOT OUTWEIGH THE POTENTIAL RISK OF NEUROPSYCHIATRIC SYMPTOMS IN PATIENTS WITH ALLERGIC RHINITIS, RESERVE USE FOR PATIENTS WHO HAVE AN INADEQUATE RESPONSE OR INTOLERANCE TO ALTERNATIVE THERAPIES (1.3, 5.1). RECENT MAJOR CHANGES Indications and Usage (1.3, 1.4) 02/2021 Dosage and Administration (2.1, 2.2, 2.3, 2.4) 02/2021 Warnings and Precautions (5.1, 5.6) 02/2021 INDICATIONS AND USAGE SINGULAIR 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. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (1.3). Limitations of Use: Not indicated to treat an acute asthma attack (5.2). DOSAGE AND ADMINISTRATION Administration ( Soma hati kamili