英文药名: ACTOplus Met (Pioglitazone/Metformin Tablets)
中文药名: 盐酸吡格列酮二甲双胍片
生产厂家: Takeda Pharmaceuticals
药物介绍
复方盐酸吡格列酮(pioglitazoneHC1)/盐酸二甲双胍(meforminHC1)片是日本武田制药株式会社研制开发的一种新型用于治疗Ⅱ型糖尿病的复方口服制剂。并于2005年8月获得FDA批准上市,商品名为ACTOplus。特别适用于辅助调节饮食和锻炼来控制血糖浓度的Ⅱ型糖尿病患者(联合用过吡格列酮与二甲双胍但单一用药不能控制)。
适应症
本品将两种广泛使用的糖尿病治疗药盐酸吡格列酮和盐酸二甲双胍制成单一片剂。盐酸吡格列酮直接作用于胰岛素耐受性,盐酸二甲双胍主要减少肝脏产生的葡萄糖量。两种药物结合有助于控制Ⅱ型糖尿病患者的血糖浓度。
用法用量
一日1次,或分剂服用,一日最大剂量不多于吡格列酮45mg和二甲双胍2550mg。(本品减少了患者原一日服用的药物的剂量,提高服药顺应性。) 任何疑问,请遵医嘱!
LINCOLNSHIRE, Ill., August 29, 2005 ?Takeda Pharmaceuticals North America, Inc. (TPNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ACTOplus metTM for the treatment of type 2 diabetes. This is the second Takeda product approved in the U.S. this summer, following the approval of ROZEREMTM (ramelteon) on July 22, 2005. ACTOplus met combines ACTOS (pioglitazone HCl) and metformin, two widely used diabetes medications, in a single tablet. ACTOS directly targets insulin resistance, a condition where the body does not efficiently use the insulin it produces, and metformin acts primarily by reducing the amount of glucose produced by the liver. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels.
To offer physicians greater flexibility in treating their patient's needs, ACTOplus met will be available in two dosages of pioglitazone/metformin ?15 mg/500 mg and 15 mg/850 mg ?both of which are to be given once a day or in divided doses not exceeding the maximum recommended daily doses of pioglitazone 45 mg and metformin 2,550 mg as mentioned in the approved labeling.
"To reach target blood glucose levels, many people with type 2 diabetes will have to take a combination of therapies. In fact, within three years of being prescribed their first medication, approximately 50 percent of patients will need to add additional therapies to manage their condition," said Ralph DeFronzo, M.D., professor of Medicine and chief of the Diabetes Division at the University of Texas Health Science Center at San Antonio. "ACTOplus met may help patients reduce the number of pills they take each day, and offers a new and convenient treatment option."
According to the American Diabetes Association, diabetes affects more than 18 million people, and type 2 diabetes is the most common form of the disease. Both ACTOS and metformin are widely used medications in the treatment of type 2 diabetes and both have a known safety profile. Combining these medications may provide patients with an easier way to take the two drugs, as they are already often prescribed together to help manage the disease.
Takeda Global Research & Development Center, Inc. submitted the ACTOplus met NDA in October 2004. Takeda expects the medication to be available to patients by October 2005.
"Takeda is committed to developing appropriate treatment options for healthcare providers and their patients," said Mark Booth, president of Takeda Pharmaceuticals North America, Inc. "ACTOplus met reflects that commitment by offering a convenient option for people with type 2 diabetes and an important new addition to the ACTOS portfolio."
ACTOPLUS MET XR 24小时缓释片
原产地英文商品名: ACTOPLUS MET XR TB 24HOURS (30mg/1000mg)tablet 30tablets/box 原产地英文药品名: PIOGLITAZONE HCL/METFORMIN HCL 中文参考商品译名: ACTOPLUS MET XR 24小时缓释片(30毫克/1000毫克)/片 30片/盒 中文参考药品译名: 盐酸吡格列酮/盐酸二甲双胍 生产厂家中文参考译名: 武田美国公司 生产厂家英文名: Takeda Pharmaceuticals America.Inc.
美国FDA批准ACTOplus met XR片剂(含盐酸匹格列酮和盐酸二甲双胍缓释剂)用于治疗2型糖
日本武田制药(Takeda Pharmaceutical Company Limited)及其全资子公司北美武田制药(Takeda Pharmaceuticals North America,Inc.)5月14日宣布,美国食品和药物管理局(FDA)已批准ACTOplus met XR片剂(含盐酸匹格列酮和盐酸二甲双胍缓释剂)用于治疗2型糖尿病,方便那些已经采用盐酸匹格列酮(pioglitazone HCl,ACTOS为商品名)和盐酸二甲双胍(metformin HCl)联合治疗、或者单独采用ACTOS 或二甲双胍治疗而不足以控制血糖的2型糖尿病成年患者。
武田制药将ACTOS 和盐酸二甲双胍缓释剂结合到一个药片上,这就是ACTOplus met XR。匹格列酮减轻胰岛素抵抗,二甲双胍减少肝脏生产葡萄糖,联合发挥作用,帮助2型糖尿病患者降低他们的血糖水平。
|