简介:
部份中文吡格列酮二甲双胍处方资料(仅供参考)
药品名称
吡格列酮二甲双胍片
成份
本品为复方制剂,其组份为盐酸吡格列酮和盐酸二甲双胍。
性状
本品为薄膜衣片,除去包衣后显白色或类白色。
功能主治
作为饮食控制、体育锻炼的辅助方式,用于改善2型糖尿病人的血糖控制,适用于单独使用盐酸二甲双胍治疗效果不佳的病人,以及使用盐酸吡格列酮和盐酸二甲双胍联合治疗的病人。
用法用量
一般
2型糖尿病治疗应以病人的耐受性和有效性为基础个性化治疗,应不超过每日最高推荐剂量盐酸吡格列酮45毫克,盐酸二甲双胍2000毫克。
推荐剂量
起始剂量应以病人已在使用的盐酸吡格列酮和/或盐酸二甲双胍的剂量为基础。本品一日剂量可分次服用,与食物同服可降低与盐酸二甲双胍有关的胃肠道副反应。
开始服用本品或随着剂量增加后,病人应谨慎监测与液体潴留相关的不良反应。
单独使用盐酸二甲双胍血糖控制不佳的病人,基于盐酸吡格列酮常用起始剂量(15-30mg/日),服用本品一日一次或一日两次,每次一片,根据治疗反应的评估结果再逐渐增加剂量。
使用盐酸吡格列酮和盐酸二甲双胍联合治疗转为本品治疗的病人,应根据病人正在服用盐酸吡格列酮和盐酸二甲双胍的剂量,选择服用本品一日一次或一日两次,每次一片。
最高推荐剂量
盐酸吡格列酮的最高推荐剂量为45毫克,盐酸二甲双胍的最高推荐剂量为2000毫克。
药理作用
本品含有两种用于2型糖尿病的具有不同作用机制的降糖药:盐酸二甲双胍,属双胍类;盐酸吡格列酮,属噻唑烷二酮类。
盐酸吡格列酮
盐酸吡格列酮的作用机制依赖胰岛素的存在。盐酸吡格列酮通过降低外周和肝脏的胰岛素抵抗,增加了依赖胰岛素的葡萄糖处理,降低了肝糖输出。盐酸吡格列酮为高选择性过氧化物酶体增殖激活受体γ(PPARγ)的激动剂,其主要作用机理为激活脂肪、骨骼肌和肝脏等胰岛素所作用组织的PPARγ核受体,从而调节胰岛素应答基因的转录,控制血糖的生成、转运和利用。
在糖尿病动物模型中,吡格列酮降低2型糖尿病胰岛素抵抗引起的高血糖、高胰岛素和高甘油三酯血症。在许多的胰岛素抵抗动物模型中可观察到,吡格列酮代谢产物可增加胰岛素依赖组织的敏感性。
盐酸二甲双胍
盐酸二甲双胍可改善2型糖尿病人的糖耐量,降低基础和餐后血糖。盐酸二甲双胍可降低肝糖产生,降低肠内糖吸收,并通过增加外围血糖吸收利用而提高胰岛素敏感性。
包装
**配合錠LD : 100錠(10錠×10)、140錠(14錠×10)、500錠(10錠×50)
**配合錠HD : 100錠(10錠×10)、140錠(14錠×10)、500錠(10錠×50)
http://www.info.pmda.go.jp/go/pack/3969100F1020_1_13/
Brand name : METACT Combination Tablets LD
Active ingredient: Pioglitazone hydrochlorid
Metformin hydrochloride
Dosage form: white oval tablets, major axis 13.7 mm, minor axis 8.7 mm, thickness about 6.6 mm
Print on wrapping: (Face) メタクトLD 321 (Back) メタクト LD
Effects of this medicine
This medicine improves hyperglycemia by enhancing the action of insulin and by inhibiting the production of glucose in the liver.
Usually, used for treatment of type II diabetes mellitus.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
If you have a heart disease or a history of heart disease, pulmonary disease, renal disorder, or liver disorder; have experienced lactic acidosis in the past; are on dialysis; have ketosis, diabetic coma or precoma, insulin-dependent diabetes mellitus, or infection; are in a pre- or postoperative state; have an injury, pituitary abnormality, adrenal gland disease, inadequate food intake, or debility; are doing strenuous physical exercise, or a heavy drinker; or have a bladder cancer or a history of bladder cancer, or diabetic retinopathy.
•If you are pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•General dosage regimen: for adults, take 1 tablet at a time after breakfast, once a day. Strictly follow the instructions of your doctor/pharmacist.
•If you miss a dose, continue your regular dosing schedule. DO NOT take double doses to make up for the missed dose.
•If you took too much of the medicine (more than ordered), check with your doctor/pharmacist.
•Do not stop taking the medicine without the instructions of your doctor.
Precautions while taking this medicine
•Strictly adhere to dietary instructions given and to kinesitherapy prescribed.
•As palpitation, dizziness, tremor in the hands/feet, etc. may appear due to hypoglycemia and lactic acidosis, take extra care when working at heights or operating dangerous machinery such as driving a car.
•When hypoglycemia symptoms occur, take an adequate amount of sugar (e.g., sugar, glucose, soft drinks). If you are taking the medicine concomitantly with an α-glucosidase inhibitor (drugs which delay absorption of sugar such as voglibose and acarbose), ingest glucose in case of any hypoglycemic symptoms.
•Although this drug has not been concluded to cause bladder cancer, there has been a report overseas stating that a potential risk for bladder cancer increases with increasing duration of this drug medication. Therefore, patients receiving this drug are followed by periodic urinary tests, etc. If hematuria, frequent urination, painful micturition, etc. appear, check with your doctor.
Possible adverse reactions to this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: anemia, increased blood pressure, palpitation, pressured feeling in the chest, hot flush, rash, itching, nausea, vomiting, abdominal discomfort, heartburn, abdominal pain, enlarged feeling of abdomen, diarrhea, constipation, excessive appetite, loss of appetite, dyspepsia, dizziness, light-headedness, headache, dull headache, sleepiness, malaise, lassitude, numbness, weight increase, aggravation of diabetic retinopathy, shortness of breath, muscle pain, taste abnormality, etc.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•swelling, rapid weight increase, shortness of breath, palpitation [heart failure]
•nausea, diarrhea, malaise, muscle pain [lactic acidosis]
•swelling, rapid weight increase [edema]
•loss of appetite, yellowing of the skin and whites of the eyes [liver disorder, jaundice]
•cold sweat, feeling hungry, tremor in hands/feet [hypoglycemia]
•lassitude, muscle pain, brown urine [rhabdomyolysis]
•pain in the pit of stomach, nausea, black stool [relapse of gastric ulcer]
•fever, cough, breathing difficulty [interstitial pneumonia]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out of the reach of children. Store away from direct sunlight, heat and humidity.
•Discard the remainder. Do not store them. If you dispose of unused medicines, seek advice of your pharmacist about proper disposal of drugs.
Takeda Chemical Industries, Ltd.Internal
Revised: 7/2011
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. |