Country: United States
Language: English
Source: NLM (National Library of Medicine)
MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)
Preferred Pharmaceuticals Inc.
MONTELUKAST SODIUM
MONTELUKAST 10 mg
ORAL
PRESCRIPTION DRUG
Montelukast sodium tablet is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. Montelukast sodium tablet is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older. Because the benefits of montelukast sodium tablets 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. Montelukast sodium tablets are not indicated for the treatment of an acute asthma attack. Montelukast sodium tablets are contraindicated in patients with hypersensitivity to any of its components. Risk Summary Available data from published prospective and retrospective cohort studies over d
Montelukast sodium tablets, USP 10 mg are beige colored, rounded square, biconvex, film coated tablet debossed “M10” on one side and plain on other side. They are supplied as follows: Bottles of 10 NDC 68788-9438-1 Bottles of 14 NDC 68788-9438-4 Bottles of 20 NDC 68788-9438-2 Bottles of 30 NDC 68788-9438-3 Bottles of 60 NDC 68788-9438-6 Bottles of 90 NDC 68788-9438-9 Storage Store montelukast sodium tablets, USP 10 mg film-coated 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.
Abbreviated New Drug Application
Preferred Pharmaceuticals Inc. ---------- Dispense with Medication Guide available at www.accordhealthcare.us/medication-guides MEDICATION GUIDE Montelukast Sodium Tablets (mon te loo′ kast soe′ dee um) What is the most important information I should know about montelukast sodium tablets? Serious mental health problems have happened in people taking montelukast sodium tablets or even after treatment has stopped. This can happen in people with or without a history of mental health problems. Stop taking montelukast sodium tablets 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 are Montelukast Sodium Tablets? Montelukast sodium tablets are 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). Montelukast sodium tablets does not contain a steroid. Montelukast sodium tablets are used to: 1. Prevent asthma attacks and for the long-term treatment of asthma in adults and children 15 years of age and older. Do not take montelukast sodium tablets 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 15 years of age and older. 3. Help control the symptoms of allergic rhinitis such as sneezing, stuffy nose, runny nose, and itching of the Read the complete document
MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED PREFERRED PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MONTELUKAST SODIUM TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1998 WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • • • 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) 02/2021 INDICATIONS AND USAGE Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: • • • Limitations of Use: • DOSAGE AND ADMINISTRATION Administration (by indications): • • SERIOUS NEUROPSYCHIATRIC EVENTS HAVE BEEN REPORTED IN PATIENTS TAKING MONTELUKAST SODIUM TABLETS ( 5.1). DISCUSS BENEFITS AND RISKS OF MONTELUKAST SODIUM TABLETS WITH PATIENTS AND CAREGIVERS ( 5.1). MONITOR FOR NEUROPSYCHIATRIC SYMPTOMS IN PATIENTS TAKING MONTELUKAST SODIUM TABLETS ( 5.1). DISCONTINUE MONTELUKAST SODIUM TABLETS IMMEDIATELY IF NEUROPSYCHIATRIC SYMPTOMS OCCUR ( 5.1). BECAUSE THE BENEFITS OF MONTELUKAST SODIUM TABLETS 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). Prophylaxis and chronic treatment of asthma in patients 15 years of age and older ( 1.1). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older ( 1.2). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3). Not indicated to treat Read the complete document