Drug: Actos

Generic Name: pioglitazone (PYE-oh-GLI-ta-zone)
Brand Name: Actos


Actos is used for:

Treating type 2 diabetes in certain patients. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.

Actos is a thiazolidinedione antidiabetic. It works by lowering blood sugar by making the cells of the body more sensitive to the action of insulin.

Do NOT use Actos if:

  • you are allergic to any ingredient in Actos
  • you have bladder cancer or moderate to severe heart failure
  • you have type 1 diabetes or diabetic ketoacidosis (a certain, severe problem associated with diabetes)
  • you have a history of liver problems, including jaundice (yellowing of the skin or eyes), during therapy with a similar medicine called troglitazone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Actos:

Some medical conditions may interact with Actos. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of liver problems, abnormal liver function tests, heart problems (eg, congestive heart failure [CHF]), bladder cancer, or eye or vision problems (eg, macular edema)
  • if you have swelling problems (edema)

Some MEDICINES MAY INTERACT with Actos. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Gemfibrozil, insulin, or oral antidiabetic medicines (eg, glipizide) because the risk of low blood sugar may be increased
  • Rifampin because it may decrease Actos's effectiveness, resulting in high blood sugar
  • Anticoagulants (eg, warfarin) because the risk of their side effects may be increased or their effectiveness may be decreased by Actos

This may not be a complete list of all interactions that may occur. Ask your health care provider if Actos may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Actos:

Use Actos as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Actos comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Actos refilled.
  • Take Actos by mouth with or without food.
  • Continue to take Actos even if you feel well. Do not miss any doses.
  • Taking Actos at the same time each day will help you remember to take it.
  • If you miss a dose of Actos, skip the missed dose and go back to your regular dosing schedule, unless your doctor directs you otherwise. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Actos.

Important safety information:

  • Carry an ID card at all times that says you have diabetes.
  • Proper diet, regular exercise, and regular blood sugar testing are important for best results with Actos. Follow the diet and exercise program given to you by your health care provider.
  • Check your blood sugar levels as directed by your doctor. If they are often higher than they should be and you take Actos exactly as prescribed, tell your doctor.
  • It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.
  • It may take 2 to 3 months to get the full effect from Actos. Do NOT take more than the recommended dose without checking with your doctor.
  • Actos may cause low blood sugar levels when it is used along with insulin or other oral diabetic medicines. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
  • Actos may cause ovulation in women who have not reached menopause but do not ovulate. Be sure to use effective birth control while using Actos.
  • Tell your doctor or dentist that you take Actos before you receive any medical or dental care, emergency care, or surgery.
  • Actos may be associated with an increased risk of bladder cancer. Tell your doctor right away if you notice symptoms that could be associated with bladder cancer (eg, a red color or blood in the urine, difficult or painful urination, an increased need to urinate). Discuss any questions or concerns with your doctor.
  • An increased incidence of bone fracture has been reported in women who take Actos. Tell your doctor if you have a history of bone fracture, low calcium intake, or weak bones (eg, osteoporosis). Tell your doctor right away if you experience any unusual bone pain.
  • Lab tests, including fasting blood sugar, hemoglobin A1c, eye examinations, and liver function, may be performed while you use Actos. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Actos should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Actos while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Actos.

Possible side effects of Actos:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cold-like symptoms; headache; muscle aches; sinus pain; sore throat; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; swelling of the hands, ankles, or feet; symptoms of heart failure (eg, shortness of breath; sudden, unexplained weight gain); symptoms of liver problems (eg, dark urine; stomach pain; unexplained nausea, vomiting, or loss of appetite; yellowing of the skin or eyes); symptoms of low blood sugar (eg, anxiety; chills, increased hunger, headache; increased dizziness or drowsiness; tremors); unusual bone pain; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Actos:

Store Actos between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Actos out of the reach of children and away from pets.

General information:

  • If you have any questions about Actos, please talk with your doctor, pharmacist, or other health care provider.
  • Actos is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Actos or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Actos. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Actos. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Actos.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

Source: http://www.drugs.com/

Note: This page contains information about the side effects of pioglitazone. Some of the dosage forms included on this document may not apply to the brand name Actos.

Not all side effects for Actos may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to pioglitazone: oral tablet

In addition to its needed effects, some unwanted effects may be caused by pioglitazone (the active ingredient contained in Actos). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking pioglitazone:

More common
  • Chest pain
  • decreased urine output
  • dilated neck veins
  • extreme fatigue
  • irregular breathing
  • irregular heartbeat
  • problems with teeth
  • shortness of breath
  • swelling of the face, fingers, feet, or lower legs
  • tightness in the chest
  • trouble with breathing
  • weight gain
  • wheezing
Less common
  • Pain or swelling in the arms or legs without an injury
  • pale skin
  • swelling
  • trouble with breathing when active
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Incidence not known
  • Dark urine
  • loss of appetite
  • nausea or vomiting
  • stomach pain
  • unexplained, rapid weight gain
  • yellow eyes or skin

Some of the side effects that can occur with pioglitazone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Blurred vision or other changes in vision
  • cough
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • loss of consciousness
  • muscle pain or soreness
  • problems with your teeth
  • runny or stuffy nose
  • sore throat
  • stomachache
  • sweating
  • unexplained weight loss

For Healthcare Professionals

Applies to pioglitazone: oral tablet

Cardiovascular

Common (1% to 10%): Congestive heart failure (including nonfatal and fatal cases), cardiac failure, chest pain[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity and allergic reactions[Ref]

Metabolic

Very common (10% or more): Hypoglycemia (up to 27.3%), increased weight (up to 26.2%)[Ref]

General

The most commonly reported side effects were hypoglycemia, increased weight, edema, and upper respiratory tract infection.[Ref]

Hematologic

Frequency not reported: Small reduction in mean hemoglobin and hematocrit[Ref]

Ocular

Common (1% to 10%): Visual disturbance, abnormal vision
Frequency not reported: Macular edema[Ref]

Hepatic

Uncommon (0.1% to 1%): Increased alanine aminotransferase
Frequency not reported: Decreased mean values of bilirubin, AST, alkaline phosphatase, and GGT
Postmarketing reports: Hepatocellular dysfunction[Ref]

Other

Very common (10% or more): Edema (up to 26.7%)
Common (1% to 10%): Fatigue, accidental injury, peripheral edema, asthenia, malaise[Ref]

Gastrointestinal

Common (1% to 10%): Tooth disorder, tooth abscess, gastroenteritis, diarrhea, upper abdominal pain[Ref]

Genitourinary

Uncommon (0.1% to 1%): Bladder cancer, urinary tract infection[Ref]

Musculoskeletal

Common (1% to 10%): Fractures, myalgia, pain in extremity, back pain, cramped legs, arthralgia[Ref]

Nervous system

Common (1% to 10%): Headache, Hypoesthesia[Ref]

Psychiatric

Uncommon (0.1% to 1%): Insomnia[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 13.2%)
Common (1% to 10%): Sinusitis, pharyngitis, bronchitis, influenza[Ref]

Oncologic

Uncommon (0.1% to 1%): Bladder cancer[Ref]

Source: http://www.drugs.com/

Pioglitazone Pregnancy Warnings

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Comments: Premenopausal anovulatory women may be at risk for pregnancy; these women should be informed of pregnancy risk. AU TGA pregnancy category: B3 US FDA pregnancy category: C

Animal studies have shown increased rates of post-implantation loss, delayed development, reduced fetal weights, and delayed parturition. There are no adequate and well-controlled studies in pregnant women. Additionally, abnormal blood glucose concentrations during pregnancy are associated with a higher incidence of congenital anomalies, increased neonatal morbidity, and mortality. Use of insulin in diabetics during pregnancy is recommended because it maintains blood glucose concentrations close to normal levels. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Pioglitazone Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

Source: http://www.drugs.com/

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