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GENERIC ACTOS: Pioglitazone HCl


Pioglitazone 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. The other member in this class is rosiglitazone (Avandia). (Another member of this class, troglitazone or Rezulin, was removed from the market because of liver toxicity.) Patients with type II diabetes cannot make enough insulin, and the cells of their body do not respond normally to the reduced amounts of insulin that are present. (Insulin is the hormone produced by the pancreas that stimulates cells to remove glucose from the blood.) Pioglitazone often is referred to as an "insulin sensitizer" because it attaches to the insulin receptors on cells throughout the body and causes the cells to become more sensitive (more responsive) to insulin. As a result, more glucose is removed from the blood. At least some insulin must be produced by the pancreas in order for pioglitazone to work.

Pioglitazone 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, it may alter the blood concentrations of lipids (fats) in the blood. Specifically, it decreases triglycerides and increases the "good" (HDL) cholesterol. Pioglitazone received FDA approval on July 16, 1999.

SIDE EFFECTS AND PRECAUTIONS: The most common side effects seen in clinical trials with pioglitazone alone or in combination with sulfonylureas, metformin, or insulin 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 pioglitazone alone but 15% of patients taking pioglitazone and insulin (as compared with 2% and 7% of patients receiving placebo, respectively). Fluid accumulation can lead to heart failure.

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