1995-2014美国fda批准的抗二型糖尿病药物汇总.docx

ACTOplus met (pioglitazone hydrochloride(盐酸盐) and metformin(二甲双胍) hydrochloride)The following drug information is obtained from various newswires(新闻专线), published medical journal articles, and medical conference presentations.Company:?TakedaApproval Status:?Approved(批准) August of 2005Treatment Area:?type 2 diabetesGeneral InformationACTOplus met is a single dose(剂量) combination(结合) of two approved drugs for the treatment of type 2 diabetes(糖尿病): Actos(爱妥糖) (pioglitazone) and metformin. Actos reduces insulin(胰岛素) resistance(阻力) and metformin lowers the amount(数量) of blood sugar made by the liver.ACTOplus met is specifically(特别地) indicated(表明) as an adjunct(附属物) to diet and exercise to improve glycemic(血糖的) control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and metformin or who have inadequate(不充分的) glycemic control on a thiazolidinedione alone or metformin alone.ACTOplus met is supplied as a tablet for oral administration(管理). The recommended initial dose is as follows:Starting dose for patients inadequately controlled on metformin monotherapyBased on the usual starting dose(剂量) of pioglitazone (15-30 mg daily), ACTOplus met may be initiated(开始) at either the 15 mg/500 mg or 15 mg/850 mg tablet strength once or twice daily, and gradually titrated(滴定) after assessing(评定) adequacy(足够) of therapeutic(治疗的) response.Starting dose for patients who initially responded(回答) to pioglitazone monotherapy and require additional(附加的) glycemic(血糖的) controlBased on the usual starting doses of metformin(二甲双胍) (500 mg twice daily or 850 mg daily), ACTOplus met may be initiated at either the 15 mg/500 mg twice daily or 15 mg/850 mg tablet strength once daily, and gradually titrated after assessing adequacy of therapeutic response.Starting dose for patients switching(转换) from combination(结合) therapy(治疗) of pioglitazone plus metformin as separate tabletsACTOplus met may be initiated with either the 15 mg/500 mg or 15 mg/850 mg tablet strength