Actos

Actos is a prescription medication used to treat type 2 diabetes. Actos belongs to a group of drugs called thiazolidinediones. It lowers blood sugar levels by increasing the body's response to insulin. 

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

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Takeda Pharmaceuticals America, Inc.

Actos may cause serious side effects. See “Drug Precautions” section.

The most common side effects of Actos include:

• cold-like symptoms (respiratory tract infection)
• headache
• sinus infection
• muscle pain
• sore throat

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the side effects of Actos. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medications you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• atorvastatin (Lipitor)
• gemfibrozil (Lopid)
• hormonal contraceptives (birth control pills, patches, rings, implants, and injections)
• insulin or other medications to treat diabetes
• ketoconazole (Nizoral)
• midazolam (Versed)
• nifedipine (Procardia)
• rifampin (Rifadin, Rifater, in Rifamate)

This is not a complete list of Actos drug interactions. Ask your doctor or pharmacist for more information.

Actos can cause serious side effects, including

• liver problems. Call your doctor right away if you have:
  • nausea or vomiting
  • stomach pain
  • unusual or unexplained tiredness
  • loss of appetite
  • dark urine
  • yellowing of your skin or the whites of your eyes
• broken bones (fractures). Usually in the hand, upper arm or foot in women. Talk to your doctor for advice on how to keep your bones healthy.
• bladder cancer. There may be an increased chance of having bladder cancer when you take Actos. You should not take Actos if you are receiving treatment for bladder cancer. Tell your doctor right away if you have any of the following symptoms of bladder cancer:
  • blood or red color in your urine
  • an increased need to urinate
  • pain while you urinate
• low blood sugar (hypoglycemia). This can happen if you skip meals, if you also use another medicine that lowers blood sugar or if you have certain medical problems. Lightheadedness, dizziness, shakiness, or hunger may happen if your blood sugar is too low. Call your doctor if low blood sugar levels are a problem for you.
• diabetic eye disease with swelling in the back of the eye (macular edema). Tell your doctor right away if you have any changes in your vision. Your doctor should check your eyes regularly.
• release of an egg from an ovary in a woman (ovulation) leading to pregnancy. Ovulation may happen when premenopausal women who do not have regular monthly periods take Actos. This can increase your chance of getting pregnant.
• new or worse heart failure. Actos can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough. 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

Do not take Actos if you:

• have severe heart failure
• are allergic to any of the ingredients in Actos tablets.

Talk to your doctor before taking Actos if you have either of these conditions.

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 Actos there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take starting Actos, tell your doctor if you:

• have heart failure
• have type 1 (“juvenile”) diabetes or had diabetic ketoacidosis
• have a type of diabetic eye disease that causes swelling in the back of the eye (macular edema)
• have liver problems
• are pregnant or plan to become pregnant
• are a premenopausal woman (before the “change of life”) who does not have periods regularly or at all
• 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.

Actos and some of your other medicines can affect each other. You may need to have your dose of Actos or certain other medicines changed.

Tell your doctor if you:

• are pregnant or plan to become pregnant. It is not known if Actos will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant about the best way to control your blood glucose levels while pregnant.
• are a premenopausal woman (before the “change of life”) who does not have periods regularly or at all. Actos may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking Actos. Tell your doctor right away if you become pregnant while taking Actos.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Actos passes into your milk and if it can harm your baby. You should not take Actos if you breastfeed your baby. Talk to your doctor about the best way to control your blood glucose levels while breastfeeding.

• Take Actos tablets exactly as your doctor tells you to take it.
• Your doctor may change your dose of Actos. Do not change your Actos dose unless your doctor tells you to.
• Actos may be prescribed alone or with other diabetes medicines. This will depend on how well your blood sugar is controlled.
• Take Actos one time each day, with or without food.
• If you miss a dose of Actos, take your next dose as prescribed unless your doctor tells you differently. Do not take two doses at one time the next day.
• If you take too much Actos, call your doctor or go to the nearest hospital emergency room right away.
• If your body is under stress such as from a fever, infection, accident or surgery the dose of your diabetes medicines may need to be changed. Call your doctor right away.
• Stay on your diet and exercise programs and test your blood sugar regularly while taking Actos.
• Your doctor should do certain blood tests before you start and while you take Actos.
• Your doctor should also do hemoglobin A1C testing to check how well your blood sugar is controlled with Actos.
• Your doctor should check your eyes regularly while you take Actos.
• It may take 2 to 3 months to see the full effect of Actos on your blood sugar level.

If you take too much Actos, call your doctor or go to the nearest hospital emergency room right away.

• Store Actos at 20° to 25°C (68° to 77°F). Keep Actos tablets in the original container and protect from light.
• Keep the Actos bottle tightly closed and protect from getting wet (away from moisture and humidity).
• Keep Actos and all medicines out of the reach of children.

WARNING: CONGESTIVE HEART FAILURE

• Thiazolidinediones, including Actos tablets, cause or exacerbate congestive heart failure in some patients.
• After initiation of Actos tablets and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of Actos tablets must be considered.
• Actos tablets are not recommended in patients with symptomatic heart failure.
• Initiation of Actos tablets in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated.