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metformin and pioglitazone

Generic Name: metformin and pioglitazone (met FOR min and PYE o GLI ta zone)
Brand Name: Actoplus Met, Actoplus Met XR

What is metformin and pioglitazone?

Metformin and pioglitazone is a combination of two oral diabetes medicines that help control blood sugar levels.

Metformin and pioglitazone is for people with type 2 diabetes who do not use daily insulin injections. This medication is not for treating type 1 diabetes.

Metformin and pioglitazone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about metformin and pioglitazone?

You should not use this medicine if you have severe or uncontrolled heart failure, kidney problems, active bladder cancer, metabolic acidosis, or diabetic ketoacidosis (call your doctor for treatment with insulin). Metformin and pioglitazone is not for treating type 1 diabetes.

Metformin and pioglitazone can cause or worsen congestive heart failure. Call your doctor at once if you have shortness of breath (even with mild exertion), swelling, or rapid weight gain.

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking metformin and pioglitazone.

Some people develop lactic acidosis while taking metformin. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

What should I discuss with my healthcare provider before taking metformin and pioglitazone?

You should not use this medicine if you are allergic to metformin or pioglitazone, or if you have:

  • severe or uncontrolled heart failure;

  • kidney problems;

  • active bladder cancer;

  • metabolic acidosis; or

  • diabetic ketoacidosis (call your doctor for treatment with insulin).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking metformin and pioglitazone. Be sure your caregivers know ahead of time that you are using this medication.

Some people taking metformin develop a serious condition called lactic acidosis. This may be more likely if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your risk.

To make sure metformin and pioglitazone is safe for you, tell your doctor if you have:

  • congestive heart failure or heart disease;

  • fluid retention;

  • a history of bladder cancer;

  • a history of heart attack or stroke;

  • liver disease; or

  • if you are 80 years or older.

This medication may increase your risk of developing bladder cancer. Talk with your doctor about your specific risk.

Taking metformin and pioglitazone 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 this medicine.

Follow your doctor's instructions about using this medicine if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy.

Some women using metformin and 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 be more likely than men to have bone fractures in the upper arm, hand, or foot while taking medicine that contains pioglitazone. Talk with your doctor if you are concerned about this possibility.

It is not known whether metformin and pioglitazone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Metformin and pioglitazone should not be given to a child.

How should I take metformin and pioglitazone?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take metformin and pioglitazone with meals. Take the extended-release (XR) tablet once daily with your evening meal.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

Use metformin and pioglitazone regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

If you take extra vitamin B12 while you are taking metformin and pioglitazone, take only the amount of vitamin B12 that your doctor has prescribed.

Metformin and pioglitazone is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking metformin and pioglitazone?

Avoid drinking alcohol. It can lower your blood sugar and may increase your risk of lactic acidosis.

Metformin and pioglitazone side effects

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

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:

  • shortness of breath (even with mild exertion), swelling, rapid weight gain;

  • pink or red urine, painful or difficult urination, new or worsening urge to urinate;

  • pale skin, easy bruising or bleeding;

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

  • changes in your vision.

Common side effects may include:

  • headache;

  • diarrhea; or

  • cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat.

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.

Side Effects (complete list)

Metformin and pioglitazone dosing information

Usual Adult Dose for Diabetes Type 2:

Individualize dose based on safety, efficacy, and prior therapy
-All doses provided as pioglitazone/metformin

Immediate-release (IR):
Initial dose: 15 mg/500 mg IR orally twice a day or 15 mg/850 mg IR orally once a day
-For patients inadequately control on metformin monotherapy: May initiate with 15 mg/850 mg IR orally twice a day (depending on previous metformin dose)
-For patients with NYHA Class I or Class II CHF: Initial dose: 15 mg/500 mg IR or 15 mg/850 mg IR orally once a day
Maintenance dose: Gradually titrate dose based on safety and efficacy
Maximum dose: Pioglitazone 45 mg/Metformin 2550 mg per day

Extended-release (XR):
Initial dose: 15 mg/1000 mg XR or 30 mg/1000 mg XR orally once a day
-For patients inadequately control on pioglitazone or metformin monotherapy: 15 mg/1000 mg XR twice a day (depending on previous metformin dose) or 30 mg/1000 mg XR orally once a day
Maintenance dose: Gradually titrate dose based on safety and efficacy
Maximum dose: Pioglitazone 45 mg/Metformin 2000 mg per day

Comments:
-Initial doses for patients receiving combination therapy as separate tablets should be as close as possible to current regimen.
-Take with meals and gradually titrate metformin doses to reduce gastrointestinal side effects; metformin doses above 2000 mg may be better tolerated given 3 times a day.
-After initiation of therapy, and with each dose increase, carefully monitor for adverse reactions related to fluid retention.
-If hypoglycemia occurs with concomitant use of insulin or insulin secretagogue, the insulin or insulin secretagogue dose should be reduced.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and metformin is appropriate.

What other drugs will affect metformin and pioglitazone?

Tell your doctor if you use insulin. Taking metformin and pioglitazone while you are using insulin may increase your risk of serious heart problems.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • gemfibrozil;

  • morphine;

  • ranitidine;

  • an antibiotic--rifampin, trimethoprim, vancomycin; or

  • heart or blood pressure medication--digoxin, nifedipine, procainamide, quinidine.

You may be more likely to have hyperglycemia (high blood sugar) if you also take other drugs that can raise blood sugar, such as:

  • isoniazid;

  • diuretics (water pills);

  • steroids (prednisone and others);

  • niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);

  • phenothiazines (Compazine and others);

  • thyroid medicine (Synthroid and others);

  • birth control pills and other hormones; and

  • diet pills or medicines to treat asthma, colds or allergies.

These lists are not complete and many other medicines can increase or decrease the effects of metformin and pioglitazone on lowering your blood sugar. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about metformin and pioglitazone.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 11.02.

Last reviewed: December 13, 2016
Date modified: December 03, 2017

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