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Product description Safety information Side effects

Drug Name

Actos (Pioglitazone)

Drug Uses

Actos is used for the treatment of type II diabetes along with a healthy diabetic diet, regular exercise, weight control, smoking reduction, and careful monitoring of blood glucose.

Actos may be used alone or in combination with metformin, a drug in a different class of anti-diabetic drugs, that also lowers blood glucose.

Actos is approved for treating type II diabetes in combination with insulin as well as another class of anti-diabetic drugs, the sulfonylureas.

How Taken

Actos is prescribed once daily in doses ranging from 15 to 45 mg. It may be taken any time of the day, with or without meals.

Drug Class and Mechanism

Actos is a drug that reduces the amount of glucose (sugar) in the blood. It is in a class of anti-diabetic drugs, called "thiazolidinediones", that are used in the treatment of type II diabetes.

Actos also lowers the level of glucose in the blood by reducing the production and secretion of glucose into the blood by the liver. In addition, actos may alter the blood concentrations of lipids (fats) in the blood. Specifically, it decreases triglycerides and increases the "good" (HDL) cholesterol.

Missed Dose

If a dose is missed on one day, two doses should not be taken the next day to make up for the missed dose.

Storage

Store this medicine at room temperature between 15-30 degrees C (59-86 degrees F).

Warnings/Precautions

Do not stop using this medicine or other diabetes medicine without first checking with your doctor.

Check with your doctor before adjusting the dose of your diabetes medicine or changing your diet.

If you are taking this medicine with other diabetes medicine, you are at an increased risk of becoming hypoglycemic (low blood sugar).Discuss with your doctor or nurse how to handle hypoglycemic reactions.

Keep all doctor and laboratory appointments while you are using this medicine. Laboratory and/or medical tests such as liver function tests and HBA1C blood levels may be done to monitor your progress or to check for side effects.

Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using this medicine.

Before you start taking any new medicine, either prescription or over-the-counter, check with your doctor or pharmacist. For women taking birth control pills: this medicine may decrease the effectiveness of your birth control pill. To prevent pregnancy, use an additional form of birth control.

For women: this medicine may increase your chance of pregnancy by causing ovulation to resume in premenopausal women who have not been ovulating. If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using this medicine during pregnancy.

Do not breast-feed while taking this medicine.

Possible Side Effects

The most common side effects seen in clinical trials with Actos were

• upper respiratory tract infection, headache, sinusitis, muscle aches, tooth disorders, hypoglycemia, and sore throat.

In addition, fluid accumulation (edema) occurred in less than 5% of patients taking actos alone but 15% of patients taking Actos and insulin (as compared with 2% and 7% of patients receiving placebo, respectively). Fluid accumulation can lead to heart failure.

To date, no formal studies to evaluate drug interactions of actos with other drugs have been conducted. Nevertheless, because it interacts with the liver enzymes that eliminate some other drugs, there is the potential for actos to increase the elimination of such drugs as erythromycin, calcium channel blockers (e.g., Cardizem), cisapride (Propulsid), corticosteroids, cyclosporine, tacrolimus, triazolam (e.g., Halcion), trimetrexate, and HMG-CoA reductase inhibitors (e.g., Lipitor).

Since another thiazolidinedione antidiabetic drug has been associated with liver injury, it is recommended that periodic monitoring of liver-related side effects and liver function be done in patients taking actos.

Side effects while taking Actos which may be due to liver injury include nausea, vomiting, abdominal pain, fatigue, anorexia (loss of appetite), or dark urine. Blood liver tests also are recommended during actos therapy.

More Information

Follow the dietary and exercise plan, provided by your doctor.

Carry an identification card at all times that says you are diabetic.

Monitor your blood sugar levels regularly according to your doctor's directions. If your blood sugar level is often higher or lower than it should be and you are taking this medicine according to directions, check with your doctor.

Do not share this medicine with others for whom it was not prescribed.

Do not use this medicine for other health conditions. Keep this product out of the reach of children. If using this medicine for an extended period of time, obtain refills before your supply runs out.