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GENERIC NAME: PIOGLITAZONE - ORAL (pie-oh-GLIT-uh-zone)

USES
Pioglitazone is an anti-diabetic drug (thiazolidinedione-type, also called "glitazones") used along with a proper diet and exercise program to control high blood sugar in patients with type 2 diabetes (non-insulin-dependent diabetes). It works by helping to restore your body's proper response to insulin, thereby lowering your blood sugar. Effectively controlling high blood sugar helps prevent heart disease, strokes, kidney disease, blindness, and circulation problems, as well as sexual function problems (impotence). Pioglitazone is used either alone or in combination with other anti-diabetic medications (e.g., metformin, sulfonylureas, insulin).

HOW TO USE
Take this medication by mouth, with or without food, usually once daily, or as directed by your doctor. Dosage is based on your medical condition, response to therapy, and if you are taking other anti-diabetic drugs. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day. Monitor blood glucose levels on a regular basis. It may take up to 2 to 3 months before the full benefit of this drug takes effect. Take all other medications for diabetes as directed by your doctor.

SIDE EFFECTS
Sore throat, muscle pain, or tooth problems may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling, unexplained rapid weight gain, trouble breathing, unusual fatigue, fast/pounding heartbeat, changes in menstrual cycles. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: dark urine, yellowing of eyes/skin, persistent nausea/vomiting, stomach/abdominal pain. This medication usually does not cause low blood sugar (hypoglycemia), but this effect may occur if you do not consume enough calories (from food, juices, fruit, etc.). The symptoms include chills, cold sweat, dizziness, drowsiness, shaking, rapid heart rate, weakness, headache, fainting, tingling of the hands or feet, or hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you are in a situation where you don't have these reliable forms of glucose, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule and do not skip meals. 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 immediately. Your medication dosage may need to be increased. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

OVERDOSE
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

MISSED ODSE
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE
Store at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

PRECAUTIONS
Before taking pioglitazone, tell your doctor or pharmacist if you are allergic to it; if you are allergic to other "glitazones" (e.g., rosiglitazone, troglitazone); or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: type 1 diabetes (insulin-dependent diabetes), newly diagnosed or worsening heart failure (acute congestive heart failure), very high blood glucose (diabetic ketoacidosis), active liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., chronic congestive heart failure), liver problems, fluid in your lungs, swelling (edema), anemia. You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcohol while taking this medication because it can increase the risk of developing hypoglycemia. During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor, as a change in your medication may be required. This medication can cause changes in the menstrual cycle (ovulation) in women with certain fertility problems. Consult your doctor or pharmacist about the use of reliable birth control while taking 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. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

WARNING
Pioglitazone and other similar medications for diabetes may cause or worsen congestive heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body). Before you start to take pioglitazone, tell your doctor if you have or have ever had congestive heart failure, especially if your heart failure is so severe that you must limit your activity and are only comfortable when you are at rest or you must remain in a chair or bed. Also tell your doctor if you were born with a heart defect, and if you have or have ever had swelling of the arms, hands, feet, ankles, or lower legs; heart disease; high cholesterol or fats in the blood; high blood pressure; coronary artery disease (narrowing of the blood vessels that lead to the heart); a heart attack; or an irregular heartbeat. Your doctor may tell you not to take pioglitazone or may monitor you carefully during your treatment.

If you develop congestive heart failure, you may experience certain symptoms. Tell your doctor immediately if you have any of the following symptoms, especially when you first start taking pioglitazone or after your dose is increased: large weight gain in a short period of time; shortness of breath; swelling of the arms, hands, feet, ankles, or lower legs; swelling or pain in the stomach; waking up short of breath during the night; needing to sleep with extra pillows in order to breathe while lying down; frequent dry cough; or increased tiredness.

Talk to your doctor about the risks of taking pioglitazone.