药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201271000331214.PDF)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文美沙拉嗪处方资料(仅供参考)
FDA批准LIALDA(美沙拉嗪)用于治疗活动期轻度至中度溃疡性结肠炎 贝辛斯托克(英国)和费城(美国)2007年1月16日——Shire制药公司(伦敦证券交易所代码:SHP;纳斯达克交易代码:SHPGY;多伦多证券交易所代码:SHQ)今日宣布,美国FDA已经批准具有MMX技术的LIALDA(美沙拉嗪)用于活动期轻度至中度溃疡性结肠炎的诱导缓解治疗。LIALDA是FDA首个、也是唯一批准的一日一次的口服美沙拉嗪制剂。美沙拉嗪属于氨基水杨酸类药物,含有5-氨基水杨酸(5-ASA),后者是一种常用的、也是治疗轻度至中度溃疡性结肠炎的一线药物。Shire制药公司的LIALDA将于2007年第一季度在美国上市。 具有MMX技术的每日一次的LIALDA,每片含有美沙拉嗪最高剂量(1.2g),所以患者每日只需服用2片,而其他美沙拉嗪制剂每日需要服用3-4次和6-16片。最近由美国局限性肠炎和结肠炎基金会承担的一项研究发现,65%的溃疡性结肠炎患者用药依从性不好,例如服药量大和服用不方便。 “面对这一严重状况,LIALDA作为治疗溃疡性结肠炎的首个每日一次的口服药物在美国获得FDA批准,对于患者和医生都是一个非常好的消息。” Shire公司首席执行官Matthew Emmens说道。“每日一次的LIALDA是Shire公司期望于2007年在美国和欧洲上市的多个药物之一。” FDA的批准是基于两项III期临床试验的结果,该结果表明LIALDA (2.4 g/每日 和 4.8 g/每日)服用8周后,与安慰剂比较,可有效地诱导缓解治疗溃疡性结肠炎。LIALDA总体上具有良好的耐受性,与目前应用的此类药物具有类似的安全性。 “临床试验证实LIALDA是一种有效的药物,与安慰剂相比具有出色的起效速率。”宾州大学医院炎症性肠病中心主任、首席研究员Gary R. Lichtenstein博士说道。“这是自2000年以来首次进入市场的新的美沙拉嗪类治疗手段,它填补了医生和溃疡性结肠炎患者的用药空白,也简化了该疾病的治疗。” “这种更加方便的剂量制剂的引入,对于保证溃疡性结肠炎患者用药依从性是一个重要的步骤。” 美国局限性肠炎和结肠炎基金会全国科学咨询委员会主席Jonathan Braun说道。Shire公司从Giuliani S.p.A.公司获得了该产品在美国、加拿大、欧洲(除意大利)和环太平洋国家的独占性开发与商业权。Giuliani S.p.A.公司保留其在意大利的开发与商业权。米兰Cosmo制药公司开发了MMX技术并拥有MMX商标权。
英文药名: Lialda (Mesalamine Delayed Release Tablets)
中文药名: 美沙拉嗪缓释片
药品名称 英文名: Mesalazine, Mesalamine 别名: 5-氨基水杨酸 5-Amino Salicylic Acid
规格 缓释片剂:1.2g。
适应症 美沙拉嗪缓释片剂用于治疗溃疡性结肠炎、Crohn病。 用法用量 一日1次, 遵医嘱。 SPD476(美国商品名Lialda;欧洲商品名Mezaant;其他国家为MMX美沙拉嗪)是一种新型、一日1次用高浓度美沙拉嗪制剂,利用多基质系统(MMX)技术使活性药物在整个结肠释放。
不良反应 1.可能引起轻微胃肠不适、恶心、口干、便秘或腹泻。 2.个别人有头晕、头痛、定向障碍;关节痛、痉挛性肌痛及氨基转移酶和BUN升高。
注意事项 1.对水杨酸类药物及本品的赋形剂过敏者忌用。 2.肝、肾功能不全者慎用。怀孕及哺乳的病人慎用。2岁以下儿童不宜用。 3.本品与氰钴胺片剂(维生素B12片)同时服用时,将影响氰钴胺片的吸收。 4.用法注意: 片剂:最好整粒吞服,也可掰开或用水冲服;但绝不可嚼碎或压碎。若因故漏服一剂量时,应尽快补服或与下次剂量同时补服。若有多次剂量漏服,仍按处方继续服用及尽快与医师联系。 栓剂:使用前应先排便,用乳胶指套将栓剂从肛门塞入,若栓剂在10分钟内流泻时,需重新塞入另一栓剂,为方便塞入,可用水、凡士林及其他润滑物润湿。若因故漏用一剂量时,应按处方继续使用,若多次剂量漏用,仍按处方继续使用。
Indication Lialda is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.
Important Safety Information You should not take Lialda if you are allergic to salicylates (including mesalamine, aspirin, or aspirin-containing products) or to any of the ingredients of Lialda. Reports of problems with kidney function have been associated with mesalamine-containing products like Lialda. Tell your doctor if you have or have had problems with your kidneys. It is recommended that all patients have their kidney function checked before starting Lialda and periodically while on therapy. Products that contain mesalamine, like Lialda, have been associated with a condition that may be difficult to distinguish from an ulcerative colitis flare-up. Symptoms include cramping, stomach ache, bloody diarrhea, fever, headache, and rash. If you experience any of these symptoms, talk to your doctor immediately. Your doctor may decide to discontinue your medication. Tell your doctor if you are allergic to sulfasalazine, as you may also be allergic to Lialda or drugs that contain or are converted to mesalamine. Some patients taking Lialda or mesalamine-containing products have reported heart-related allergic reactions, such as inflammation of the heart muscle and inflammation of the lining of the heart. Tell your doctor if you have or have had a history of myocarditis or pericarditis as this may increase your likelihood of having these types of reactions. Reports of liver failure have been associated with mesalamine-containing products like Lialda in patients that have or have had liver disease. Tell your doctor if you have a problem with your liver. Tell your doctor if you have a stomach blockage, as this may delay the release of medication. In clinical trials, common side effects reported with Lialda included ulcerative colitis, headache, gas, abnormal liver function test results, and stomach ache. Inflammation of the pancreas was reported which led to discontinuation of Lialda therapy. Other side effects may occur. Before starting Lialda, tell your doctor about all medications you are taking. Mesalamine may increase the risk of kidney problems when used with non-steroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen). Mesalamine may increase the risk of blood disorders when used with azathioprine and 6-mercaptopurine.
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201271000331214.PDF)的“原文Priscribing Information”为准 --------------------------------------------------------------- |