Actoplus Met (generic: pioglitazone/metformin) is a prescription medication used with diet and exercise to treat adults with type 2 diabetes.
Actoplus Met is a single tablet containing two different prescription medications, pioglitazone and Glucophage metformin. Actos is an insulin-sensitizer. It causes cells to respond better to insulin, which makes them absorb glucose from the blood. Glucophage is called a biguanide antidiabetic medication. It causes the liver to make less glucose. Either of these drugs can be used to lower blood sugar levels, but some patients respond better when taking both medications.
Actoplus Met comes in tablet form and is usually taken once or twice daily, with food. It is also available as Actoplus Met XR, which contains the extended-release form of metformin. Actoplus Met XR is usually taken once a day with the evening meal.
Common side effects include diarrhea, nausea, weight gain, and respiratory infection (cold-like symptoms).
Actoplus MET is a prescription medicine used for adults with type 2 diabetes who:
- are taking Actos alone and do not have enough blood sugar control,
- are taking glucophage alone and do not have enough blood sugar control, or
- are already taking both pioglitazone and metformin.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Actoplus MET can cause serious side effects. See "Drug Precautions".
Common side effects of Actoplus MET are:
- cold-like symptoms (upper respiratory infection),
- urinary tract infection,
- sinus infection,
Tell your doctor if you have any side effect that bothers you or that does not go away. This is not a complete list of Actoplus MET side effects. For more information, ask your doctor or pharmacist.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
- birth control pills
- cimetidine (Tagamet)
- a calcium channel blocker
- cough and cold products that contain a decongestant
- seizure medicines
- thyroid medicines
This is not a complete list of Actoplus MET drug interactions. Ask your doctor or pharmacist for more information.
Actoplus MET can cause serious side effects, including new or worse heart failure (a condition in which the heart does not pump blood well enough). One of the medicines in Actoplus MET can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. This can make some heart problems worse or lead to heart failure.
Call your doctor right away if you have any of the following:
- swelling or fluid retention, especially in the ankles or legs.
- shortness of breath or trouble breathing, especially when you lie down.
- an unusually fast increase in weight.
- unusual tiredness.
One of the medicines in Actoplus MET, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.
Call your doctor right away if you get the following symptoms, which could be signs of lactic acidosis:
- extreme weakness or tiredness
- unusual muscle pain
- stomach pains, nausea (upset stomach) or vomiting
- difficulty breathing
- dizziness or lightheadedness
- slow or irregular heartbeat
Your doctor should do blood tests to check your liver before you start taking Actoplus MET and during treatment as needed.
- Tell your doctor right away if you have any changes in your vision as Actoplus MET has caused macular edema (diabetic eye disease with swelling in the back of the eye). Your doctor should check your eyes regularly.
- Actoplus MET can affect your bones. It can cause fractures (broken bones), usually in the hand, upper arm, or foot in women.
- Low red blood cell count (anemia) has been caused by Actoplus MET.
- Do not skip meals. Lightheadedness, dizziness, shakiness, are signs that your blood sugar is too low.
- Ovulation may happen when premenopausal women who do not have regular monthly periods take Actoplus MET. This can increase the chance of pregnancy.
Do not take Actoplus MET if you are allergic to any of the ingredients in Actoplus MET. See "Forms of Medication".
Tell your doctor if you:
- have kidneys disease
- are going to have certain x-ray procedures with an injection of dyes (contrast agents) in your vein with a needle
- have severe heart failure
- are under the age of 18 years of age
Your doctor may stop your Actoplus MET for a while if you have any of the conditions listed above.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Actoplus MET there are no specific foods that you must exclude from your diet when receiving Actoplus MET.
Before receiving Actoplus MET tell your doctor about all of your medical conditions, especially if you:
- have heart failure
- have kidney problems
- have alcoholism (all the time or short binge drinking)
- have type 1 ("juvenile") diabetes or had diabetic ketoacidosis
- are 80 years old or older
- have a type of diabetic eye disease called macular edema (swelling of the back of the eye)
- have liver problems
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.
Tell your doctor about all of your medical conditions, especially if you:
- are pregnant or plan to become pregnant. Actoplus MET should not be used during pregnancy. It is not known if Actoplus MET can harm your unborn baby.
- are a premenopausal woman (before the "change of life"), who does not have periods regularly or at all. Actoplus MET may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking Actoplus MET. Tell your doctor right away if you become pregnant while taking Actoplus MET.
Tell your doctor about all of your medical conditions, especially if you are breastfeeding or plan to breastfeed. It is not known if Actoplus MET is excreted in human breast milk or if it can harm your nursing baby.
Actoplus MET comes as a tablet to be taken by mouth, usually once a day. It can be taken with or without food, but by taking it with food, you may lower your chance of an upset stomach. Take this medication at the same time each day. Your doctor may start you on a low dose and gradually increase the dose as needed. Do not change your dose unless told to do so by your doctor. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not take two doses at one time.
Continue taking Actoplus MET even if you feel well.
Diet and exercise are an important part of controlling your diabetes. Follow all exercise and dietary recommendations your doctor provides. Test your blood sugar regularly while taking Actoplus MET.
Your doctor should do blood tests before starting Actoplus MET and from time to time to check your liver, kidneys, blood cells, and hemoglobina A1C. Your doctor should also do regular blood tests (for example, hemoglobin A1C) to check how well your blood sugar is controlled with Actoplus MET.
Take Actoplus MET exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. Your doctor may start you on a low dose and gradually increase the dose as necessary. Doses range from Actoplus MET 15 mg/500 mg to Actoplus MET 45 mg/2550 mg.
Actoplus MET tablets are available as a 15 mg pioglitazone plus 500 mg metformin or a 15 mg pioglitazone plus 850 mg metformin formulation for oral administration. The maximum recommended dose for pioglitazone is 45 mg daily. The maximum recommended daily dose for metformin is 2550 mg in adults.
If you take too much Actoplus MET call your doctor or local Poison Control Center right away.
Active Ingredients: pioglitazone hydrochloride and metformin hydrochloride
Inactive Ingredients: povidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose 2910, polyethylene glycol 8000, titanium dioxide, and talc. Always check to make sure that the medicine you are taking is the correct one.
Actoplus MET tablets:
15 mg/500 mg strength tablets—white to off-white, oblong tablet with "15/500" on one side and "4833M" on the other.
15 mg/850 mg strength tablets—white to off-white, oblong tablet with "15/850" on one side and "4833M" on the other.
- Store Actoplus MET at room temperature in the original container to protect it from light.
- Keep the Actoplus MET bottle tightly closed and protect from getting wet (away from moisture and humidity).
- Keep Actoplus MET and all medicines out of the reach of children.
CONGESTIVE HEART FAILURE
Thiazolidinediones, including pioglitazone, which is a component of Actoplus MET, cause or exacerbate congestive heart failure in some patients. After initiation of Actoplus MET, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to the current standards of care. Furthermore, discontinuation or dose reduction of Actoplus MET must be considered.
Actoplus MET is not recommended in patients with symptomatic heart failure. Initiation of Actoplus MET in patients with established NYHA Class III or IV heart failure is contraindicated.
- Lactic acidosis is a rare, but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.
- The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate.
- If acidosis is suspected, Actoplus MET should be discontinued and the patient hospitalized immediately