Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
ROFLUMILAST (UNII: 0P6C6ZOP5U) (ROFLUMILAST - UNII:0P6C6ZOP5U)
Strides Pharma Science Limited
ORAL
PRESCRIPTION DRUG
Roflumilast tablets are indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of Use Roflumilast tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm. The use of roflumilast is contraindicated in the following condition: Moderate to severe liver impairment (Child-Pugh B or C) [see Clinical Pharmacology (12.3) and Use in Specific Populations (8.6)] . Risk Summary There are no randomized clinical studies of Roflumilast in pregnant women. In animal reproductive toxicity studies, Roflumilast administered to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. The highest Roflumilast dose in these studies was approximately 30 and 26 times, respectively, the maximum recommended human dose (MRHD). Roflumilast induced post-implantation loss in rats at doses greater than or equal to approximately 10 times the MRHD
Roflumilast tablets are supplied as white to off-white, round tablets, debossed with "0.5" on one side, "R" on the other side. Each tablet contains 500 mcg of roflumilast. Roflumilast tablets are available in bottles of 30 (NDC 64380-786-01) and 90 (NDC 64380-786-05). Store roflumilast tablets, 500 mcg 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].
Abbreviated New Drug Application
ROFLUMILAST - ROFLUMILAST TABLET Strides Pharma Science Limited ---------- MEDICATION GUIDE Roflumilast Tablets (roe flue' mi last) Read this Medication Guide before you start taking roflumilast tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. What is the most important information I should know about roflumilast tablets? Roflumilast tablets can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking roflumilast tablets. 1. Roflumilast tablets may cause mental health problems including suicidal thoughts and behavior. Some people taking roflumilast tablets may develop mood or behavior problems including: • thoughts of suicide or dying • attempt to commit suicide • trouble sleeping (insomnia) • new or worse anxiety • new or worse depression • acting on dangerous impulses • other unusual changes in your behavior or mood 2. Weight loss. Roflumilast tablets can cause weight loss. You should check your weight on a regular basis. You will also need to see your healthcare provider regularly to have your weight checked. If you notice that you are losing weight, call your healthcare provider. Your healthcare provider may ask you to stop taking roflumilast tablets if you lose too much weight. Roflumilast tablets may affect the way other medicines work, and other medicines may affect how roflumilast tablets work. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. What are roflumilast tablets? Roflumilast tablets are a prescription medicine used in adults with severe Chronic Obstructive Pulmonary Disease (COPD) to decrease the number of flare-ups or the worsening of COPD symptoms (exacerbations). Roflumilast tablets are not a bronchodilator and should not be used for treating sudden breathing proble Citiți documentul complet
ROFLUMILAST - ROFLUMILAST TABLET STRIDES PHARMA SCIENCE LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ROFLUMILAST TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ROFLUMILAST TABLETS. ROFLUMILAST TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2011 INDICATIONS AND USAGE Roflumilast tablet is a selective phosphodiesterase 4 inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. (1, 14) (1) Limitations of Use_:_ Roflumilast tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm. (1, 14) (1) DOSAGE AND ADMINISTRATION The maintenance dose for patients with COPD is one 500 mcg tablet per day, with or without food. Starting treatment with a dose of roflumilast tablet 250 mcg once daily for 4 weeks and increasing to roflumilast tablet 500 mcg once daily thereafter may reduce the rate of treatment discontinuation in some patients. (2) (2) DOSAGE FORMS AND STRENGTHS Tablets: 500 mcg (3) (3) CONTRAINDICATIONS Moderate to severe liver impairment (Child-Pugh B or C) (4) (4) WARNINGS AND PRECAUTIONS Acute Bronchospasm: Do not use for the relief of acute bronchospasm. (5.1) Psychiatric Events including Suicidality: Advise patients, their caregivers, and families to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. Carefully weigh the risks and benefits of treatment with roflumilast in patients with a history of depression and/or suicidal thoughts or behavior. (5.2) Weight Decrease: Monitor weight regularly. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of roflumilast. (5.3) Drug Interactions: Use with strong cytochrome P450 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoi Citiți documentul complet