Generic Name: pioglitazone (oral) (PYE o GLIT a zone)
Brand Names: Actos

Actos is an oral diabetes medicine that helps control blood sugar levels.

Actos is for people with type 2 (non-insulin-dependent) diabetes. It is sometimes used in combination with insulin or other medications, but it is not for treating type 1 diabetes.

Actos may also be used for purposes other than those listed in this medication guide.

Important information about Actos

Do not use Actos if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before taking Actos, tell your doctor if you have congestive heart failure or heart disease, a history of heart attack or stroke, or liver disease.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them, including hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure (convulsions), fainting, or coma (severe hypoglycemia can be fatal). Always keep a source of sugar available in case you have symptoms of low blood sugar.

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

Certain oral diabetes medications 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 Actos.

Before taking Actos

Do not use Actos if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you have any of these other conditions, you may need to adjust your dose of Actos or have special tests:

• congestive heart failure or heart disease;

• a history of heart attack or stroke; or

• liver disease.

Certain oral diabetes medications 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 Actos.

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

FDA pregnancy category C. It is not known whether Actos is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pioglitazone passes into breast milk or if it could harm a nursing baby. Do not take Actos without first talking to your doctor if you are breast-feeding a baby.

How should I take Actos?

Take Actos exactly as it was prescribed by your doctor. Do not take in larger or smaller amounts, or take it for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results from Actos.

This medicine is usually taken once daily. You may take Actos with or without food.

Actos is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your doctor may also recommend other medicines to treat your diabetes.

It is important to use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure Actos is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested, and you may need regular eye exams. It is important that you not miss any scheduled visits to your doctor.

Your medication needs may change if you become sick or injured, if you have a serious infection, or if you have any type of surgery. Your doctor may want you to stop taking Actos for a short time if any of these situations affect you.

Take care not to let your blood sugar get too low, causing hypoglycemia. You may have hypoglycemia if you skip a meal, exercise too long, drink alcohol, or are under stress.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them:

• hunger, headache, confusion, irritability;

• drowsiness, weakness, dizziness, tremors;

• sweating, fast heartbeat;

• seizure (convulsions); or

• fainting, coma (severe hypoglycemia can be fatal).

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Store Actos at room temperature away from moisture, heat, and light.

See also: Actos dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. 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. You may have signs of low blood sugar, such as hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure (convulsions), fainting, or coma.

What should I avoid while taking Actos?

Avoid drinking alcohol while taking Actos. Alcohol lowers blood sugar and may increase the risk of hypoglycemia while you are taking this medicine.

Actos side effects

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. Stop using Actos and call your doctor at once if you have any of these serious side effects:

• feeling short of breath, even with mild exertion;

• swelling or rapid weight gain;

• chest pain, general ill feeling;

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

• blurred vision;

• increased thirst or hunger, urinating more than usual; or

• pale skin, easy bruising or bleeding, weakness.

Less serious Actos side effects may include:

• sneezing, runny nose, cough or other signs of a cold;

• headache;

• gradual weight gain;

• muscle pain; or

• tooth problems.

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.

See also: Actos side effects in more detail

What other drugs will affect Actos?

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

• isoniazid;

• diuretics (water pills);

• steroids (prednisone and others);

• phenothiazines (Compazine and others);

• thyroid medicine (Synthroid and others);

• birth control pills and other hormones;

• seizure medicines (Dilantin and others); and

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

You may be more likely to have hypoglycemia (low blood sugar) if you take Actos with other drugs that lower blood sugar, such as:

• some nonsteroidal anti-inflammatory drugs (NSAIDs);

• aspirin or other salicylates (including Pepto-Bismol);

• sulfa drugs (Bactrim and others);

• a monoamine oxidase inhibitor (MAOI);

• beta-blockers (Tenormin and others); or

• probenecid (Benemid).

The following drugs can interact with Actos:

• midazolam (Versed);

• gemfibrozil (Lopid);

• rifampin (Rifadin);

• furosemide (Lasix); or

• nifedipine (Adalat, Procardia).

This list is not complete and other drugs may interact with Actos. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Actos.

What does my medication look like?

Pioglitazone is available with a prescription under the brand name Actos. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about Actos, especially if it is new to you.

• Actos 15 mg - white, round tablets

• Actos 30 mg - white, round tablets

• Actos 45 mg - white, round tablets

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Actos only for the indication prescribed.
• 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.

• Pioglitazone Pregnancy and Breastfeeding Warnings

  Pioglitazone is also known as: Actos

  Overview

  If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pioglitazone while you are pregnant. It is not known if Pioglitazone is found in breast milk. Do not breast-feed while taking Pioglitazone
  .
  

  Pioglitazone Pregnancy Warnings

  Pioglitazone has been assigned to pregnancy category C by the FDA. Animal studies have not revealed evidence of teratogenicity. Delayed parturition and embryotoxicity were observed in both rats and rabbits. There are no controlled data in human pregnancy. Pioglitazone is only recommended for use during pregnancy when benefit outweighs risk.

  Pioglitazone Breastfeeding Warnings

  There are no data on the excretion of pioglitazone into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking in to account the importance of the drug to the mother.