Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
MONTELUKAST (UNII: MHM278SD3E) (MONTELUKAST - UNII:MHM278SD3E)
Camber Pharmaceuticals, Inc.
MONTELUKAST
MONTELUKAST 4 mg
ORAL
PRESCRIPTION DRUG
Montelukast sodium chewable tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. Montelukast sodium chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. sodium chewable tablets are 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 of age and older. Because the benefits of montelukast sodium chewable tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis , use for patients who have an inadequate response or intolerance to alternative therapies. Montelukast sodium chewable tablets are 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. Because the ben
Montelukast Sodium Chewable Tablets 4 mg are light pink to pink colored, speckled, oval, biconvex shaped, chewable tablets debossed with 'I' on one side and '112' on the other side. They are supplied as follows: Bottles of 30 tablets NDC 31722-727-30 Bottles of 90 tablets NDC 31722-727-90 Bottles of 100 tablets NDC 31722-727-01 Bottles of 1000 tablets NDC 31722-727-10 Blister card of 10 Unit-dose tablets NDC 31722-727-31 Blister pack of 100 (10 x 10) Unit-dose tablets NDC 31722-727-32 Montelukast Sodium Chewable Tablets 5 mg are light pink to pink colored, speckled, round, biconvex shaped, chewable tablets debossed with 'I' on one side and '113' on the other side. Bottles of 30 tablets NDC 31722-728-30 Bottles of 90 tablets NDC 31722-728-90 Bottles of 100 tablets NDC 31722-728-01 Bottles of 1000 tablets NDC 31722-728-10 Blister card of 10 Unit-dose tablets NDC 31722-728-31 Blister pack of 100 (10 x 10) Unit-dose tablets NDC 31722-728-32 . Storage Store at 20° to 25°C (68° to 77°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-resistance container.
Abbreviated New Drug Application
MONTELUKAST SODIUM - montelukast sodium tablet, chewable Camber Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Montelukast Sodium Chewable Tablets (mon te loo’ kast soe’dee um) What is the most important information I should know about montelukast sodium chewable tablets? Serious mental health problems have happened in people taking montelukast sodium chewable 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 chewable 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 muscle movements sleeping • uncontrolled What are montelukast sodium chewable tablets? Montelukast sodium chewable 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 chewable tablets do not contain a steroid. Montelukast sodium chewable tablets are used to: 1. Prevent asthma attacks and for the long-term treatment of asthma in adults and children ages 2 years and older. Do not take montelukast sodium chewable 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 6 years of age and older. 3. Help control the symptoms of allergic rhinitis such as sneezing, Olvassa el a teljes dokumentumot
MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, CHEWABLE CAMBER PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MONTELUKAST SODIUM CHEWABLE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST SODIUM CHEWABLE TABLETS, FOR ORAL USE 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 MONTELUKAST SODIUM ( 5.1). • DISCUSS BENEFITS AND RISKS OF MONTELUKAST SODIUM WITH PATIENTS AND CAREGIVERS ( 5.1). • MONITOR FOR NEUROPSYCHIATRIC SYMPTOMS IN PATIENTS TAKING MONTELUKAST SODIUM ( 5.1). • DISCONTINUE MONTELUKAST SODIUM IMMEDIATELY IF NEUROPSYCHIATRIC SYMPTOMS OCCUR ( 5.1). • BECAUSE THE BENEFITS OF MONTELUKAST SODIUM 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 Boxed Warning 04/2020 Indications and Usage, Allergic Rhinitis ( 1.3) 04/2020 Dosage and Administration, Asthma ( 2.1), Allergic Rhinitis (2.3), Asthma and Allergic Rhinitis ( 2.4) 04/2020 Warnings and Precautions, Neuropsychiatric Events ( 5.1) 04/2020 INDICATIONS AND USAGE Montelukast sodium chewable 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. Reserve use for patients who have an inadequate response or intolerance to alt Olvassa el a teljes dokumentumot