糖尿病复方缓释药物Actoplus Met XR获得FDA批准

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 (Pioglitazone / Metformin)

Actoplus Met is a combination of two oral diabetes medicines that help control blood sugar levels.

Actoplus Met is for people with type 2 diabetes who do not use daily insulin injections. This medication is not for treating type 1 diabetes.

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

What is the most important information I should know about Actoplus Met (Pioglitazone / Metformin)?

Do not use Actoplus Met if you have kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before taking Actoplus Met, tell your doctor if you have congestive heart failure or heart disease, a history of heart attack or stroke, liver disease, or eye problems caused by diabetes.

Some people have developed a life-threatening condition called lactic acidosis while taking Actoplus Met. Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Actoplus Met. Be sure the surgeon knows ahead of time that you are using this medication.

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.

Some women using Actoplus Met 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.

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 Actoplus Met.

What should I discuss with my healthcare provider before taking Actoplus Met (Pioglitazone / Metformin)?

Some people have developed a life-threatening condition called lactic acidosis while taking Actoplus Met. Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.

You may be more likely to develop lactic acidosis if you have congestive heart failure.

Do not use Actoplus Met if you have kidney disease, 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 dose adjustment or special tests to safely take Actoplus Met. Before taking this medication, tell your doctor if you have::

• congestive heart failure or heart disease;
• a history of heart attack or stroke;
• liver disease; or
• eye problems caused by diabetes.

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Actoplus Met. Be sure the surgeon knows ahead of time that you are using this medication.

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 Actoplus Met.

Some women using Actoplus Met 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.

FDA pregnancy category C. It is not known whether Actoplus Met 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 metformin or pioglitazone passes into breast milk or if it could harm a nursing baby. Do not take Actoplus Met without telling your doctor if you are breast-feeding a baby. Older adults may have a higher risk of developing lactic acidosis. Talk with your doctor about your individual risk.

How should I take Actoplus Met (Pioglitazone / Metformin)?

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.

Take Actoplus Met with meals.

Actoplus Met is only part of a complete program of treatment that also includes diet, exercise, and weight control. 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 kidney or 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 Actoplus Met 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.

Your doctor may have you take extra vitamin B12 while you are taking Actoplus Met. Take only the amount of vitamin B12 that your doctor has prescribed.

Store Actoplus Met at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). 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. An overdose of Actoplus Met may cause a life-threatening condition called lactic acidosis. Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.

What are the possible side effects of Actoplus Met (Pioglitazone / Metformin)?

Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting. Stop using Actoplus Met and 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.

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; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious Actoplus Met side effects may include:

• sneezing, runny nose, cough or other signs of a cold;
• dizziness;
• headache;
• mild nausea, vomiting, diarrhea, stomach pain; or
• joint or muscle pain.

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 Actoplus Met (Pioglitazone / Metformin)?

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

• 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).

Some medications may interact with Actoplus Met. Tell your doctor if you are using any of the following drugs:

• furosemide (Lasix);
• nifedipine (Adalat, Procardia);
• cimetidine (Tagamet) or ranitidine (Zantac);
• amiloride (Midamor) or triamterene (Dyrenium);
• digoxin (Lanoxin);
• morphine (MS Contin, Kadian, Oramorph);
• procainamide (Procan, Pronestyl, Procanbid);
• quinidine (Cardioquin, Quinidex, Quinaglute);
• trimethoprim (Proloprim, Primsol, Bactrim, Cotrim, Septra); or
• vancomycin (Vancocin, Lyphocin).

If you are using any of these drugs, you may not be able to take Actoplus Met, or you may require a dosage adjustment or special monitoring.

There may be other drugs not listed that can affect Actoplus Met. 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.