药品名：盐酸吡格列酮盐酸二甲双胍缓释片

剂型与规格：缓释包衣片剂，15mg/1000mg；30mg/1000mg

适应症：Ⅱ型糖尿病

原研单位及国外上市时间：武田制药株式会社研发，2009年5月获得FDA批准上市，商品名ACTOPLUS MET® XR

FDA批准ACTOplus met(R) XR片剂用于治疗2型糖尿病

美通社-PR Newswire5月13日伊利诺伊州迪尔菲尔德和日本大阪电Takeda Pharmaceutical Company Limited 及其全资子公司 Takeda Pharmaceuticals North America, Inc. 今天宣布，美国食品和药物管理局 (U.S. Food and Drug Administration, FDA) 已批准将缓释型组合药物 ACTOplus met(R)（盐酸匹格列酮 (pioglitazone HCl) 和盐酸二甲双胍 (metformin HCl)）作为治疗2型糖尿病的一种饮食和锻炼辅助剂。ACTOplus met(R) XR 是首款也是唯一一款带有二甲双胍缓释剂的抗糖尿病固定剂量口服组合药物，旨在通过每天一次的方便的剂量选择帮助改善血糖控制。ACTOplus met XR 用于对已经采用 ACTOS(R)（盐酸匹格列酮）和二甲双胍治疗的进行治疗，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。
ACTOplus met XR 将两种广泛使用的药物 ACTOS 和二甲双胍结合到一个药片上。ACTOS 直接针对胰岛素抵抗。胰岛素抵抗是一种身体不能有效使用身体产生的胰岛素的疾病。二甲双胍通过减少肝脏产生的葡萄糖的数量起作用。这些药物联合发挥作用，帮助2型糖尿病患者管理他们的血糖水平。
ACTOplus met XR 的主要活性成分之一二甲双胍缓释剂由 Watson Pharmaceuticals, Inc. 子公司 Watson Laboratories 开发而成，并授权给 Takeda Pharmaceutical Company Limited。
Actoplus Met为胶囊剂，该药含有武田公司已有的另一种糖尿病药Actos（罗格列酮）和二甲双胍两种成分。
武田制药美国分公司将在十月份推出Actoplus Met。它将与葛兰素史克公司的Avandamet进行竞争，Avandamet含有罗格列酮和二甲双胍。
Actos直接作用于胰岛素阻抗性----即人体无法有效利用自身产生的胰岛素，而二甲双胍主要用于减少人体肝脏产生的葡萄糖数量。
武田公司称，这种复方制剂可以减少II型糖尿病患者的血糖浓度。

What is Actos (Pioglitazone)?

Pioglitazone is an oral diabetes medicine that help control blood sugar levels.

Pioglitazone is for people with type 2 (non-insulin-dependent) diabetes. Pioglitazone is sometimes used in combination with insulin or other medications, but it is not for treating type 1 diabetes.

Pioglitazone may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Actos (Pioglitazone)?

Do not use pioglitazone if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before taking pioglitazone, tell your doctor if you have congestive heart failure or heart disease, a history of heart attack or stroke, or liver disease.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them, including hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure (convulsions), fainting, or coma (severe hypoglycemia can be fatal). Always keep a source of sugar available in case you have symptoms of low blood sugar. Some women using pioglitazone have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control. Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking pioglitazone. Talk with your doctor if you are concerned about this possibility. Taking certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with pioglitazone.

What should I discuss with my healthcare provider before taking Actos (Pioglitazone)?

Do not use pioglitazone if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you have certain conditions, you may need a dosage adjustment or special tests to sfaely take this medication. Before taking pioglitazone, tell your doctor if you have:

• congestive heart failure or heart disease;
• a history of heart attack or stroke; or
• liver disease.

Taking certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with pioglitazone. Some women using pioglitazone have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control. Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking pioglitazone. Talk with your doctor if you are concerned about this possibility. FDA pregnancy category C. It is not known whether pioglitazone is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pioglitazone passes into breast milk or if it could harm a nursing baby. Do not take pioglitazone without first talking to your doctor if you are breast-feeding a baby.

How should I take Actos (Pioglitazone)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger or smaller amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Pioglitazone is usually taken once daily. You may take the medicine with or without food.

Pioglitazone is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your doctor may also recommend other medicines to treat your diabetes.

It is important to use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested, and you may need regular eye exams. It is important that you not miss any scheduled visits to your doctor.

Your medication needs may change if you become sick or injured, if you have a serious infection, or if you have any type of surgery. Your doctor may want you to stop taking pioglitazone for a short time if any of these situations affect you.

Take care not to let your blood sugar get too low, causing hypoglycemia. You may have hypoglycemia if you skip a meal, exercise too long, drink alcohol, or are under stress.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them:

• hunger, headache, confusion, irritability;
• drowsiness, weakness, dizziness, tremors;
• sweating, fast heartbeat;
• seizure (convulsions); or
• fainting, coma (severe hypoglycemia can be fatal).

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Store pioglitazone at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. You may have signs of low blood sugar, such as hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure (convulsions), fainting, or coma.

Actos (Pioglitazone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using pioglitazone and call your doctor at once if you have any of these serious side effects:

• feeling short of breath, even with mild exertion;
• swelling or rapid weight gain;
• chest pain, general ill feeling;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• blurred vision;
• increased thirst or hunger, urinating more than usual; or
• pale skin, easy bruising or bleeding, weakness.

Continue taking this medication and talk to your doctor if you have any of these less serious side effects:

• sneezing, runny nose, cough or other signs of a cold;
• headache;
• gradual weight gain;
• muscle pain; or
• tooth problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Actos (Pioglitazone)?

You may be more likely to have hyperglycemia (high blood sugar) if you are taking pioglitazone with other drugs that raise blood sugar. Drugs that can raise blood sugar include:

• isoniazid;
• diuretics (water pills);
• steroids (prednisone and others);
• phenothiazines (Compazine and others);
• thyroid medicine (Synthroid and others);
• birth control pills and other hormones;
• seizure medicines (Dilantin and others); and
• diet pills or medicines to treat asthma, colds or allergies.

You may be more likely to have hypoglycemia (low blood sugar) if you are taking pioglitazone with other drugs that lower blood sugar. Drugs that can lower blood sugar include:

• some nonsteroidal anti-inflammatory drugs (NSAIDs);
• aspirin or other salicylates (including Pepto-Bismol);
• sulfa drugs (Bactrim and others);
• a monoamine oxidase inhibitor (MAOI);
• beta-blockers (Tenormin and others); or
• probenecid (Benemid).

The following drugs can interact with pioglitazone:

• midazolam (Versed);
• gemfibrozil (Lopid);
• rifampin (Rifadin);
• furosemide (Lasix); or
• nifedipine (Adalat, Procardia).

This list is not complete and there may be other medications that can interact with pioglitazone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

关于：盐酸吡格列酮盐酸二甲双胍缓释片

盐酸吡格列酮为噻唑烷二酮类抗糖尿病药物，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，本品不是一个胰岛素促分泌药。其作用机制是高选择性的激动过氧化物酶小体生长因子活化受体-γ[PPAR-γ]，PPAR-γ的活化可调节许多控制葡萄糖及脂类代谢的胰岛素相关基因的转录。实验表明，本品可减少胰岛素抵抗的高血糖、高胰岛素因症及高三酰甘油。本品引起的代谢变化导致了依赖胰岛素的组织应答的增加。由于本品提高了循环胰岛素的作用（即降低胰岛素抵抗），因此它不能降低缺乏内源性胰岛素的血糖。

复方产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。