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当前位置:药品说明书与价格首页 >> 糖尿病 >> 新药推荐 >> ACTOPLUS MET XR(复方盐酸吡格列酮/盐酸二甲双胍缓释片)

ACTOPLUS MET XR(复方盐酸吡格列酮/盐酸二甲双胍缓释片)

2011-10-12 14:42:35  作者:新特药房  来源:中国新特药网天津分站  浏览次数:251  文字大小:【】【】【
简介: 武田药品株式会社的全资子公司武田制药北美公司宣布,FDA已经批准其盐酸吡格列酮+盐酸二甲双胍复方缓释片剂(ACTOplus met XR)用于2型糖尿病治疗。本品只需一日1次用药,是首个含缓释二甲双胍的口服复 ...

通用的名称和配方:
吡格列酮(盐酸) ,盐酸二甲双胍缓释; 15mg/1000mg , 30mg/1000mg的标签。
公司名称:
武田制药北美公司
主治为ACTOPLUS MET XR :
吡格列酮或二甲双胍单独的辅助饮食和运动改善血糖控制在2型糖尿病患者已经对吡格列酮和二甲双胍,或当反应是不够的。
成人剂量为MET ACTOPLUS XR :
整个吞下,每天提供一次晚餐个体化以前吡格列酮和/或二甲双胍:开关毫克/毫克基础上最初15mg/1000mg的或30mg/1000mg每日一次,可能8-12周后进行调整;最大45mg ....二甲双胍每天pioglitazone/2000mg老人,虚弱,营养不良:最大剂量不推荐。
儿童剂量为MET ACTOPLUS XR :
不推荐使用。
请参见:
ACTOPLUS MET
药理类别:
噻唑烷二酮类药物+双胍类。
禁忌症:
NYHA III级或IV心脏衰竭,肾脏疾病或功能障碍,代谢性酸中毒,酮症酸中毒,伴随血管内的碘造影剂(暂停期间和使用后48小时内) 。
警告/注意事项:
用于治疗1型糖尿病症状的心力衰竭:不推荐CHF : NYHA心功能II级:在批准的最低剂量和滴定开始....不小心水肿可能会增加血浆量(心脏衰竭的症状/体征监视器) ,停止心脏状况恶化或如果发生乳酸性酸中毒,休克,急性心肌梗塞,败血症,或低氧血症。确认肾功能正常,然后开始和显示器(尤其是在患者≥ 80yrs ) 。避免肝脏疾病。不要开始治疗活动性肝病或如果ALT > 2.5xULN显示器在基线ALT ,然后如果ALT 1 2.5xULN的定期随访,密切监测;停止,如果ALT> 3xULN ,仍然存在或如果发生黄疸曲格列酮相关黄疸史的患者不适合使用。暂停治疗,如果发生脱水或术前监测血(尤其是在易感患者血清维生素B12 )应力老年,衰弱,无偿剧烈运动,营养不良或不足的热量摄入,肾上腺或垂体功能不全,或酒精中毒:风险增加低血糖恢复排卵无排卵患者绝经前,可能会出现(可能会导致意外怀孕)的怀孕( Cat.C ;不建议考虑使用胰岛素代替)哺乳母亲:不推荐。
相互作用:
见禁忌。增强的CYP2C8抑制剂(如吉非贝齐)拮抗CYP2C8诱导剂(如利福平) 。拮抗口服避孕药,咪达唑仑,监视器与胰岛素的心脏衰竭。阳离子避免过度的酒精摄入量(会加强二甲双胍对乳酸的影响) 。由肾小管分泌,速尿,硝苯地平:消除药物可能会增加二甲双胍水平高血糖的风险增加,利尿剂,类固醇,吩噻嗪,苯妥英钠,拟交感神经药,钙通道阻滞剂,烟酸,甲状腺激素,雌激素,口服避孕药,异烟肼β-受体阻滞剂可能掩盖低血糖症。
不良反应:
上呼吸道感染,胃肠道不适,水肿,头痛,尿路感染,头晕,体重增加,乳酸性酸中毒(罕见的,一半的病例是致命的) ;妇女骨折的风险。
如何提供:
标签60 XR标签- 30 ,60,90 ,180 ;

糖尿病复方缓释药物Actoplus Met XR获得FDA批准
2009年5月14日,武田制药公司(Takeda Pharmaceutical Company Limited)宣布,美国食品药品管理局(FDA)已批准复方缓释药Actoplus Met XR(匹格列酮和二甲双胍)用于治疗2型糖尿病。该药可辅助饮食和运动,共同治疗2型糖尿病。Actoplus Met XR适用于治疗曾接受过Actos (匹格列酮)和二甲双胍治疗的2型糖尿病成人患者或经Actos单药治疗或二甲双胍单药治疗后血糖控制不佳的2型糖尿病成人患者。
Actoplus Met XR中的Actos可直接针对胰岛素抵抗起作用。第2个成分——二甲双胍,可通过减少肝脏生成的葡萄糖量而发挥作用。
Actoplus Met XR治疗可引起或加重充血性心力衰竭。患者如果出现体重迅速增加、液体潴留或气短,则应与经治医生联系。此外,少数服用二甲双胍的患者会出现乳酸酸中毒。在约半数情况下,乳酸酸中毒具有致命性。由于乳酸酸中毒最常发生于有肾脏疾病的患者,因此不应为肾病患者或年龄≥80岁的肾功能损害患者开具Actoplus Met XR处方。另外,代谢性酸中毒患者或酗酒患者也不应服用Actoplus Met XR。严重感染患者和采用静脉注射造影剂进行放射学检查的患者不应停用Actoplus met XR。
患者应在接受Actoplus Met XR治疗前进行肝功能实验室检查,并在此后定期进行此类检查。Actoplus Met XR禁用于患有活动性肝病的患者。患者如果出现恶心、呕吐、腹痛、疲劳、食欲不振、皮肤发黄或尿色变暗,则应与经治医生联系。
ACTOPLUS MET XR Rx Generic Name and Formulations:
Pioglitazone (as HCl), metformin HCl extended-release; 15mg/1000mg, 30mg/1000mg; tabs.

Company:
Takeda Pharmaceuticals North America, Inc.

Indications for ACTOPLUS MET XR:
Adjunct to diet and exercise to improve glycemic control in type 2 diabetes in patients already on pioglitazone and metformin, or when response to pioglitazone or metformin alone is inadequate.

Adult Dose for ACTOPLUS MET XR:
Swallow whole. Give once daily with the evening meal. Individualize. Previously on pioglitazone and/or metformin: switch on a mg/mg basis. Initially 15mg/1000mg or 30mg/1000mg once daily; may adjust after 8–12 weeks; max 45mg pioglitazone/2000mg metformin per day. Elderly, debilitated, malnourished: max doses not recommended.

Children's Dose for ACTOPLUS MET XR:
Not recommended.

See Also:
ACTOPLUS MET

Pharmacological Class:
Thiazolidinedione + biguanide.

Contraindications:
NYHA Class III or IV heart failure. Renal disease or dysfunction. Metabolic acidosis, ketoacidosis. Concomitant intravascular iodinated contrast agents (suspend during and for 48 hours after use).

Warnings/Precautions:
Not for treating type 1 diabetes. Symptomatic HF: not recommended. CHF: NYHA Class II: start at lowest approved dose and titrate carefully. Edema. May increase plasma volume (monitor for signs/symptoms of heart failure); discontinue if cardiac status deteriorates, or if lactic acidosis, shock, acute MI, sepsis, or hypoxemia occurs. Confirm normal renal function before starting and monitor (esp. in patients ≥80yrs). Avoid in hepatic disease. Do not start therapy in active liver disease or if ALT >2.5xULN. Monitor ALT at baseline, then periodically. If ALT 1–2.5xULN, follow-up and monitor closely; discontinue if ALT >3xULN persists or if jaundice occurs. Not for use in patients with history of troglitazone-associated jaundice. Suspend therapy if dehydration occurs or before surgery. Monitor blood (esp. serum Vit. B12 in susceptible patients). Stress. Elderly, debilitated, uncompensated strenuous exercise, malnourished or deficient caloric intake, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Resumption of premenopausal ovulation in anovulatory patients may occur (may result in unintended pregnancy). Pregnancy (Cat.C; not recommended; consider using insulin instead). Nursing mothers: not recommended.

Interactions:
See Contraindications. Potentiated by CYP2C8 inhibitors (eg, gemfibrozil). Antagonized by CYP2C8 inducers (eg, rifampin). Antagonizes oral contraceptives, midazolam. Monitor for heart failure with insulin. Avoid excessive alcohol intake (potentiates effects of metformin on lactate). Cationic drugs eliminated by renal tubular secretion, furosemide, nifedipine: may increase metformin levels. Increased risk of hyperglycemia with diuretics, steroids, phenothiazines, phenytoin, sympathomimetics, calcium channel blockers, niacin, thyroid products, estrogens, oral contraceptives, isoniazid. β-blockers may mask hypoglycemia.

Adverse Reactions:
Upper respiratory tract infection, GI upset, edema, headache, urinary tract infection, dizziness, weight gain, lactic acidosis (rare, half the cases are fatal); also women: risk of fracture.

How Supplied:
Tabs—60, 180; XR tabs—30, 60, 90

责任编辑:admin


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