Actos

DRUG DESCRIPTION

ACTOS (pioglitazone hydrochloride) is an oral antidiabetic medication.

Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown:

ACTOS (pioglitazone hydrochloride) Structural Formula Illustration

Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3S•HCl and a molecular weight of 392.90 daltons. It is soluble in N,N?­dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether.

ACTOS is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF.

What are the possible side effects of pioglitazone (Actos)?

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 pioglitazone 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...

Read All Potential Side Effects and See Pictures of Actos »

What are the precautions when taking pioglitazone hydrochloride (Actos)?

Before taking pioglitazone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (such as congestive heart failure, chest pain), diabetic ketoacidosis, liver disease, fluid in your lungs, swelling (edema), anemia, a certain eye problem (macular edema).

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform...

Read All Potential Precautions of Actos »


Actos Consumer (continued)

SIDE EFFECTS: See also Warning section.

Sore throat, muscle pain, weight gain, or tooth problems may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if either of these serious side effects occurs: new/worsening vision problems (such as blurred vision), bone fracture.

Pioglitazone may rarely cause liver disease. Tell your doctor right away if you develop symptoms of liver disease, including: dark urine, yellowing of eyes/skin, persistent nausea/vomiting, stomach/abdominal pain.

Pioglitazone does not usually cause low blood sugar (hypoglycemia). Low blood sugar may occur if this drug is prescribed with other anti-diabetic medications (such as insulin or a sulfonylurea). Low blood sugar is more likely if you drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking pioglitazone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (such as congestive heart failure, chest pain), diabetic ketoacidosis, liver disease, fluid in your lungs, swelling (edema), anemia, a certain eye problem (macular edema).

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase the risk of developing low blood sugar.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because increased stress may require a change in your treatment plan, medications, or blood sugar testing.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Pioglitazone may increase the risk of bone fracture in women (usually in the upper arm, hand, or foot). See also Notes section.

Pioglitazone can cause changes in the menstrual cycle (promote ovulation) and increase the risk of becoming pregnant. Consult your doctor or pharmacist about the use of reliable birth control while using this medication.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Your doctor may substitute insulin for this drug during your pregnancy. Follow all instructions carefully.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Actos Patient Information Including Side Effects

Brand Names: Actos

Generic Name: pioglitazone (oral) (Pronunciation: PYE o GLIT a zone)

  • What is pioglitazone (Actos)?
  • What are the possible side effects of pioglitazone (Actos)?
  • What is the most important information I should know about pioglitazone (Actos)?
  • What should I discuss with my healthcare provider before taking pioglitazone (Actos)?
  • How should I take pioglitazone (Actos)?
  • What happens if I miss a dose (Actos)?
  • What happens if I overdose (Actos)?
  • What should I avoid while taking pioglitazone (Actos)?
  • What other drugs will affect pioglitazone (Actos)?
  • Where can I get more information?

What is pioglitazone (Actos)?

Pioglitazone is an oral diabetes medicine that help control blood sugar levels.

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

Pioglitazone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of pioglitazone (Actos)?

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 pioglitazone 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.

Continue taking this medication and talk to your doctor if you have any of these less serious side effects:

  • 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.

What is the most important information I should know about pioglitazone (Actos)?

Do not use pioglitazone 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 pioglitazone, 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 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 also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking pioglitazone. Talk with your doctor if you are concerned about this possibility.

Taking 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 pioglitazone.

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