About ACTOS

What is ACTOS?

  • ACTOS is a once-a-day prescription medication for type 2 diabetes that, along with healthy eating and physical activity, helps your body control blood sugar (glucose) levels.
  • ACTOS makes the cells in your body more sensitive to insulin, a hormone produced by the pancreas that allows the cells in your body to use blood sugar for energy.
  • When the cells are more sensitive to insulin, the sugar that’s in your blood can pass more easily into the cells of your body where it’s really needed. So instead of remaining in the blood, where sugar can build up to dangerous levels, it passes into the cells and your blood sugar levels go down.
  • ACTOS can be used by itself or in combination with certain other diabetes medications (sulfonylureas, metformin, or insulin) when your necessary efforts at healthy eating and physical activity do not control your blood sugar levels.
  • ACTOS may improve HDL (good) cholesterol and triglycerides without consistent changes in LDL (bad) cholesterol or total cholesterol in patients with type 2 diabetes. However, ACTOS should not be substituted for cholesterol medicine.

ACTOS is a member of the type of oral diabetes prescription medications called thiazolidinediones (THIGH-ah-ZO-li-deen-DYE-owns; TZDs). These medications help reduce insulin resistance, which is one of the major problems in type 2 diabetes. Some of the benefits of therapy with ACTOS are:

  • With diet and exercise, lowers blood sugar by helping your body use its own insulin more effectively.
  • Convenient, once-a-day pill can be taken anytime.
  • Can be taken with or without food.
  • ACTOS may improve HDL (good) cholesterol and triglycerides without consistent changes in LDL (bad) cholesterol or total cholesterol in patients with type 2 diabetes. However, ACTOS should not be substituted for cholesterol medicine.
  • Has not been associated with stomach upset when used alone.
  • Can be used alone or in combination with certain other diabetes medicines such as sulfonylureas, metformin, or insulin. Taken alone, ACTOS is not likely to cause hypoglycemia (low blood sugar levels). However, if you take ACTOS with insulin or sulfonylureas, you may be at increased risk for hypoglycemia. Talk to your doctor about the signs and symptoms of hypoglycemia.
  • ACTOS is available in three different dose levels so you and your health professional have more treatment options to consider.
  • ACTOS is also available in convenient combination tablets:
    • ACTOplus met combines ACTOS and metformin in one tablet.
    • Duetact combines ACTOS and glimepiride in one tablet.
  • ACTOS can often begin working right away, although it may take several weeks to see the full change.

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

To learn more about ACTOS, please see ACTOS Complete Prescribing Information and Medication Guide.

To learn more about ACTOplus met, please see ACTOplus met Complete Prescribing Information and Medication Guide.

To learn more about duetact, please see duetact Complete Prescribing Information and Medication Guide.

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

The major underlying problems in type 2 diabetes are insulin resistance in muscle and fat, decreased insulin production by the pancreas, and increased sugar production by the liver. Other concerns include lipid problems, such as increased triglyceride levels (blood fats), low levels of HDL (good cholesterol), and high levels of LDL (bad cholesterol). Gastrointestinal (stomach) and kidney function are additional considerations.

The effect of these lipid changes has not been determined.

Next: ACTOS and blood sugar (glucose)

Indications and Usage
ACTOS is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.

ACTOplus met is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.

Duetact is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.

ACTOS, ACTOplus met, and duetact are not for patients with type 1 “juvenile” diabetes or diabetic ketoacidosis.

ACTOS, ACTOplus met, and duetact have not been studied in children and are not recommended for children under the age of 18.

Important Safety Information
ACTOS, ACTOplus met, and duetact are not for everyone. Certain patients with heart failure should not start taking ACTOS, ACTOplus met, or duetact. ACTOS, ACTOplus met, and duetact can cause new, or worsen, heart failure. Talk to your doctor immediately if you experience unusually fast weight gain, fluid retention (swelling), shortness of breath, unusual tiredness, or slow heartbeat.

Warnings Specific to ACTOplus met
Metformin, 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.

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 or older whose kidneys do not work properly.

ACTOplus met should not be taken by people with metabolic acidosis.

ACTOplus met should not be taken by people who drink excessive amounts of alcohol.

Talk to your doctor if you are going to have an X-ray procedure using injectable dye and are taking ACTOplus met.

Warning Specific to duetact
The chance of death from serious heart or blood vessel problems may be higher when using a sulfonylurea, an ingredient in duetact.

Taking glimepiride along with having an inherited condition where you don’t produce enough of the enzyme G6PD (G6PD deficiency) can cause hemolytic anemia, which causes your red blood cells to be destroyed too quickly.

Do not take ACTOS, ACTOplus met, or duetact if you have active liver disease. Your doctor should perform a blood test to check for liver problems before you start ACTOS, ACTOplus met, or duetact and periodically thereafter. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes.

If you are of childbearing age, talk to your doctor before taking ACTOS, ACTOplus met, or duetact, as this could increase your chance of becoming pregnant. Talk to your doctor if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.

Some people taking ACTOS, ACTOplus met, or duetact may experience flulike symptoms, mild-to-moderate swelling of legs and ankles, anemia, and weight gain.

ACTOS may cause low blood sugar when taken in combination with insulin or sulfonylureas. Lightheadedness, shakiness, dizziness, or hunger may mean that your blood sugar is too low. Talk to your doctor if low blood sugar is a problem for you.

Patients with diabetes should have regular eye exams. If you experience vision problems, consult your doctor immediately. Some patients have experienced visual changes while taking ACTOS, ACTOplus met, or duetact.

Some people, particularly women, are at higher risk of having bone fractures while taking pioglitazone.

Other side effects of ACTOS may include cold-like symptoms, headache, sinus infection, muscle pain, tooth disorder, and sore throat.

Other side effects of ACTOplus met may include cold-like symptoms, diarrhea, nausea, headache, urinary tract infection, dizziness, sinus infection, and anemia.

Other side effects of duetact may include cold-like symptoms, headache, urinary tract infection, diarrhea, nausea, and limb pain.

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.

Please see ACTOS Complete Prescribing Information, including boxed warning and Medication Guide.
Please see ACTOplus met Complete Prescribing Information, including boxed warnings and Medication Guide.
Please see duetact Complete Prescribing Information, including boxed warning and Medication Guide.
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