药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201213100245313.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文FEBURIC处方资料(仅供参考)
治療慢性高尿酸血症藥FEBURIC® (febuxostat)獲得許可上市 帝人醫療醫藥集團旗下主要事業帝人製藥,於5月份在日本發表,治療高尿酸血症的創新藥物FEBURIC (febuxostat, TMX-67)。
FEBURIC為口服藥物,是治療具症狀(如痛風、高血壓等)或無症狀高尿酸血中首見的藥物,可有效降低高尿酸血症患者的尿酸濃度,使其低於6.0mg/dL,並適用於輕度至中度腎或肝功能不全患者,無須調整劑量;在日本,約有1600萬人為高尿酸血症所苦。
帝人製藥於1991年研發出世界首見的黃嘌呤(非普林)氧化酶抑制劑febuxostat。其與用來治療高尿酸血症長達40年的別嘌呤醇 (allopurinol)截然不同,具有創新化學結構。
Febuxostat在美國與加拿大以 ULORIC 為註冊品牌名上市,於法國、英國、德國、愛爾蘭、義大利、希臘、奧地利等歐洲國家以 ADENURIC為名推出,為一款專治療痛風患者的藥物。於中國、韓國、香港、墨西哥、加勒比海、中東與北非 (MENA )等其他國家目前已獲得許可,計畫將於以上市場推出;而帝人製藥在日本市場則已通過厚生勞動省核准上市。
帝人製藥將 febuxostat 定位為全球策略性產品,預期在未來,此全新藥物全球年營業額能達到一千億日元
What is Febuxostat? Febuxostat is the generic name given to a new drug which comes in film-coated tablets of 40 mg, 80 mg and 120 mg and is used to reduce high uric acid levels (hyperuricemia) in gout patients. It is particularly indicated where the patient already has urate crystal deposition, including the presence of tophus. It is only available on prescription.
In the United States and Canada, febuxostat is branded as Uloric, Adenuric in the European Union (EU) and Feburic in Asia.
How Does Febuxostat Work? Uric acid is naturally formed through the breakdown of purines in the body which normally expels excess acid via urine with a little through the stools. However, excess uric acid can be retained in the bloodstream when the body produces more acid than it can eliminate. High uric acid levels can eventually lead to the deposition of crystals of urate in the joints and surrounding tissue, causing the excruciating symptoms of gout.
Febuxostat is a xanthine oxidase inhibitor. Xanthine oxidase is an enzyme in the body that helps to convert purines into uric acid. Febuxostat can inhibit this activity and so can help to reduce the amount of uric acid produced.
What to Tell Your Doctor Before Taking Febuxostat You should tell your doctor if you •are pregnant •are breastfeeding •are allergic to febuxostat or any of the ingredients in the tablets •have or have had heart problems •have thyroid problems •are taking any other medications How to Take Febuxostat
Your doctor will tell you how to take it. He or she will decide on the dose applicable to your condition. This is usually a 40 mg, 80 mg or a 120 mg tablet taken once per day with a full glass of water. It can be taken with or without food. Take the tablets exactly as your doctor prescribes. If you miss a dose do not double-up on the next dose. And do not stop taking the tablets unless your doctor tells you to.
Note that, after starting on a course, you may suffer one or more gout attacks. Do not stop taking the tablets. This happens naturally as uric acid is removed from the joints and tissue because of the action of the drug. Your doctor may prescribe NSAIDs (non-steroidal anti-inflammatory drugs) to help relieve the painful symptoms.
Febuxostat Side Effects As with any drug there are possible negative side effects with the taking of febuxostat. But not everyone will suffer these side effects. In fact, most patients will tolerate it quite well. And where they do appear, they are usually fairly minor and either don’t need any treatment, or, only require some simple treatment by your physician.
Common side effects are:- headache, nausea, unexplained rash, diarrhea, liver function test abnormalities.
Uncommon are:- dizziness, fatigue, oedema, altered sense of taste, increase in blood amylase, decrease in platelet count, increase in blood creatinine, and arthralgia.
Rare side effects:- insomnia, nervousness, renal insufficiency, asthenia.
There are some rare, but serious, side effects that you should report urgently to your health-care provider. These are things such as:- •chest pain •difficulty breathing •easy bruising or bleeding •wheezing •swelling of the mouth, lips, tongue, throat, etc. •unexplained rash •itching •hives •frequent / persistent infections •numbness in arms, legs, face •liver problems (yellowing of the whites of the eyes, dark colored urine)
Note that the lists of side effects given above are not complete. For a more detailed list of possible febuxostat side effects please speak to your doctor or pharmacist.
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201213100245313.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- |