英文药名：ACTOS（Pioglitazone Hydrochloride Tablets）

中文药名：盐酸吡格列酮片

生产厂家：武田药品
药品介绍：
药理作用
本品为噻唑烷二酮类口服抗糖尿病药物，为高选择性过氧化物酶增殖体激活受体γ(PPARγ)的激动剂，属胰岛素增敏剂。作用机制与胰岛素的存在有关，可减少外周组织和肝脏的胰岛素抵抗，增加依赖胰岛素的葡萄糖的处理，并减少肝糖的输出。与磺酰脲类不同，本品不是胰岛素促分泌药，本品是通过提高外周和肝脏的胰岛素敏感性来控制血糖水平。本品能明显增加外周组织对葡萄糖的摄取，同时使血浆胰岛素水平下降，不增加体重，有利于血胆固醇和三酰甘油趋于正常。
适应证
用于2型糖尿病(或非胰岛素依赖性糖尿病，NIDDM)。
用法用量
起始剂量为每日15mg或30mg，最大剂量为45mg，在早餐前服用，如漏服1次，第2天不可用双倍剂量。
贮藏
室温密闭干燥保存，避免受潮
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name : ACTOS Tablets 15 30
　Active ingredient: Pioglitazone hydrochloride
　Dosage form: white to yellowish white tablet, φ7.0 mm, thickness 2.4 mm
　Print on wrapping: (Face) 390 (Back) アクトス15 30
Effects of this medicine
This medicine improves hyperglycemia by enhancing the action of insulin.
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, ketosis, diabetic coma or precoma, insulin-dependent diabetes mellitus, hepatic disorder, renal disorder, or severe infection; are in a pre- or post-operative state; have an injury, pituitary abnormality, adrenal disorder, 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 to 2 tablets (15 to 30 mg of pioglitazone) at a time, once a day, before or after breakfast. The dosage should be adjusted according to your gender, age and symptoms, but 3 tablets (45 mg) a day is the upper limit of dosage.
When given concomitantly with an insulin preparation, for adults, take 1 tablet (15 mg of pioglitazone) at a time, once a day, before or after breakfast. The dosage should be adjusted according to your gender, age and symptoms, but 2 tablets (30 mg) a day is the upper limit of dosage.
Strictly follow the instructions of your doctor/pharmacist.
•If you missed a dose, take the missed dose as soon as possible if prior to noon. As hypoglycemia may occur, do not take the medicine after severe exercise or on an empty stomach. 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.
•Much caution should be exercised as hypoglycemia may occur.
•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 effects of this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: anemia, increased blood pressure, palpitation, pressurized feeling in the chest, hot flush, rash, itching, nausea, vomiting, abdominal discomfort, heart burn, abdominal pain, enlarged feeling of abdomen, diarrhea, constipation, excessive appetite, loss of appetite, dizziness, light-headedness, headache, sleepiness, malaise, lassitude, numbness, weight increase, aggravation of diabetic retinopathy, shortness of breath, etc.
The symptoms described below are rarely seen as initial symptoms of the adverse effects 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]
•swelling, rapid weight increase[edema]
•loss of appetite, yellowing of the skin or whites of the eyes[liver disorder, jaundice]
•cold sweat, feeling hungry, trembling of 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.

アクトス錠15／アクトス錠30

商標名
ACTOS Tablets
化学構造式
一般名
ピオグリタゾン塩酸塩（Pioglitazone Hydrochloride）〔JAN〕
化学名
（5RS）-5-｛4-［2-（5-Ethylpyridin-2-yl）ethoxy］benzyl｝thiazolidine-2, 4-dione monohydrochloride
分子式
C19H20N2O3S・HCl
分子量
392.90
融点
193℃（分解点）
性状
ピオグリタゾン塩酸塩は白色の結晶又は結晶性の粉末である。N,N-ジメチルホルムアミド又はメタノールにやや溶けやすく、エタノール（99.5）に溶けにくく、水にほとんど溶けない。0.1mol/L塩酸試液に溶ける。N,N-ジメチルホルムアミド溶液（1→20）は旋光性を示さない。
包装
錠15 ： 100錠（10錠×10）、420錠（14錠×30）、500錠（バラ、10錠×50）

錠30 ： 100錠（10錠×10）、420錠（14錠×30）、500錠（バラ、10錠×50）

製造販売元
武田薬品工業株式会社
注：使用时请阅读完整资料[附件]：http://www.info.pmda.go.jp/go/pack/3969007F1024_1_31/