About ACTOplus met

ACTOplus met, cholesterol, and blood fats (triglycerides)

Low levels of HDL (good) cholesterol and high levels of triglycerides are often associated with type 2 diabetes. Cholesterol is a fatty substance that can be found in the body. The body needs cholesterol for making hormones and building cell walls. This combination of low HDL and high triglyceride levels can lead to health problems.

Fats in the blood

There are three main types of fat in your blood:

  • LDL (low-density lipoprotein) cholesterol is known as the “bad cholesterol” because it is the main source of harmful fatty buildup in blood vessels.
  • HDL (high-density lipoprotein) cholesterol is often called “good cholesterol” because it helps prevent cholesterol buildup in blood vessels by carrying cholesterol back to the liver, where it can be eliminated.
  • Triglycerides are a form of fat carried through the bloodstream.

ACTOplus met has a positive effect on HDL cholesterol and triglycerides

ACTOS—one of the two medications in ACTOplus met—may have a positive effect on HDL (good) cholesterol and triglycerides (blood fats) without consistent changes in LDL (bad) cholesterol or total cholesterol in patients with type 2 diabetes. ACTOS has been shown to:

  • Increase HDL cholesterol.
  • Decrease triglycerides.
  • Have no consistent effect on LDL cholesterol and total cholesterol.

If you have high cholesterol, you should ask your health professional what steps you can take to lower it. These may include:

Your health professional may also prescribe a cholesterol-lowering medication in addition to these healthy lifestyle habits. ACTOplus met is not intended to treat lipid disorders.

Next: Is ACTOplus met right for you?

While ACTOplus met may provide some lipid benefits, ACTOplus met is not intended as a substitute for cholesterol medications.

The effects of these lipid changes on morbidity and mortality have not been determined.

Management of type 2 diabetes should also include nutritional counseling, weight reduction as needed, and exercise.

Please see Important Safety Information, including warnings about heart failure and lactic acidosis, below.

Important Safety Information About ACTOplus met® (pioglitazone HCl and metformin HCl)

ACTOplus met contains two prescription antidiabetic medicines: pioglitazone HCl (ACTOS) and metformin HCl. ACTOplus met is used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes who are already taking ACTOS and metformin together, or taking metformin alone and it is not controlling blood sugar at normal levels.

ACTOplus met is not for everyone. Certain patients with heart failure should not start taking ACTOplus met. ACTOplus met can cause or worsen congestive heart failure. Talk to your doctor immediately if you experience rapid weight gain, fluid retention (swelling), or shortness of breath.

A small number of people who have taken metformin, a component of ACTOplus met, have developed a rare, serious condition called lactic acidosis. Lactic acidosis, a buildup of lactic acid in the blood, can be fatal in about half the cases. Because lactic acidosis occurs most frequently in people with kidney problems, ACTOplus met should not be used in people with kidney disease or in people 80 years of age and older whose kidneys do not work properly. ACTOplus met should not be taken by people with metabolic acidosis, or with hypersensitivity to pioglitazone, metformin, or any other component of ACTOplus met. ACTOplus met should not be taken by people who drink excessive amounts of alcohol. ACTOplus met should be discontinued in patients with severe infection or in patients undergoing X-ray studies using intravenous contrast dye. Talk to your health professional before discontinuing any medications.

Your health professional should perform a blood test to check for liver problems before you start ACTOplus met and periodically thereafter. Do not take ACTOplus met if you have active liver disease. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or yellowing of the skin. If you are of childbearing age, talk to your doctor before taking ACTOplus met, as it could increase your chance of becoming pregnant. Some people, particularly women, are at higher risk of having bone fractures while taking ACTOplus met. Patients with diabetes should have regular eye exams. If you experience vision problems, consult your doctor immediately. Very rarely, some patients have experienced visual changes while taking pioglitazone, a component of ACTOplus met.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch, or call 1-800-FDA-1088.