Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
FEBUXOSTAT (UNII: 101V0R1N2E) (FEBUXOSTAT - UNII:101V0R1N2E)
Sunshine Lake Pharma Co., Ltd.
ORAL
PRESCRIPTION DRUG
Febuxostat tablet is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. For the safe and effective use of allopurinol, see allopurinol prescribing information. Limitations of Use : Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. Febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see Drug Interactions (7)] . Risk Summary Limited available data with febuxostat tablets use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. No adverse developmental effects were observed in embryo-fetal development studies with oral a
Febuxostat tablets 40 mg are white or almost white round film-coated tablets, debossed with “C33” on one side and blank on the other side and supplied as: Febuxostat tablets 80 mg are white or almost white capsule-shaped film-coated tablets, debossed with “C32” on one side and blank on the other side and supplied as: Protect from light. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
Sunshine Lake Pharma Co., Ltd. ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: March 2019 MEDICATION GUIDE FEBUXOSTAT (fe bux' oh stat) tablets, for oral use Read the Medication Guide that comes with febuxostat tablets before you start taking it and each time you get a refill. There may be new information. The Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information that I should know about febuxostat tablets? Febuxostat tablets may cause serious side effects, including: Heart-related deaths. Call your doctor or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or worry you: • chest pain • shortness of breath or trouble breathing • dizziness, fainting or feeling lightheaded • rapid or irregular heartbeat • numbness or weakness in one side of your body • slurring of speech • sudden blurry vision or sudden severe headache What are febuxostat tablets? Febuxostat tablet is a prescription medicine called a xanthine oxidase (XO) inhibitor used to lower blood uric acid levels in adult patients with gout when allopurinol has not worked well enough or when allopurinol is not right for you. Febuxostat tablets are not for use in people who do not have symptoms of high blood uric acid levels. It is not known if febuxostat tablets are safe and effective in children. Who should not take febuxostat tablets? Do not take febuxostat tablets if you: • take azathioprine (Azasan, Imuran) • take mercaptopurine (Purinethol, Purixan) What should I tell my doctor before taking febuxostat tablets? Before taking febuxostat tablets tell your doctor about all of your medical conditions, including if you: • have taken allopurinol and what happened to you while you were taking it. • have a history of heart disease or stroke. • have liver or kidney problems. • are pregnant or plan to become pregnant. It i Prečítajte si celý dokument
FEBUXOSTAT- FEBUXOSTAT TABLET SUNSHINE LAKE PHARMA CO., LTD. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FEBUXOSTAT TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FEBUXOSTAT TABLETS. FEBUXOSTAT TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2009 WARNING: CARDIOVASCULAR DEATH _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ GOUT PATIENTS WITH ESTABLISHED CARDIOVASCULAR (CV) DISEASE TREATED WITH FEBUXOSTAT TABLETS HAD A HIGHER RATE OF CV DEATH COMPARED TO THOSE TREATED WITH ALLOPURINOL IN A CV OUTCOMES STUDY. ( 5.1) CONSIDER THE RISKS AND BENEFITS OF FEBUXOSTAT TABLETS WHEN DECIDING TO PRESCRIBE OR CONTINUE PATIENTS ON FEBUXOSTAT TABLETS. FEBUXOSTAT TABLETS SHOULD ONLY BE USED IN PATIENTS WHO HAVE AN INADEQUATE RESPONSE TO A MAXIMALLY TITRATED DOSE OF ALLOPURINOL, WHO ARE INTOLERANT TO ALLOPURINOL, OR FOR WHOM TREATMENT WITH ALLOPURINOL IS NOT ADVISABLE. ( 1) RECENT MAJOR CHANGES Boxed Warning 2/2019 Indications and Usage 2/2019 Warnings and Precautions Cardiovascular Death ( 5.1) 2/2019 INDICATIONS AND USAGE Febuxostat tablet is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. ( 1) For the safe and effective use of allopurinol, see allopurinol prescribing information. Limitations of Use: Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. ( 1) DOSAGE AND ADMINISTRATION Recommended febuxostat tablets dosage is 40 mg or 80 mg once daily. The recommended starting dose is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after 2 weeks, the recommended dosage is 80 mg once daily. ( 2.1) Can be administered without regard to food or antacid use. ( 2.1) Limit the dosage of febuxostat tablets to 40 mg once dail Prečítajte si celý dokument