Medications and Drugs
GENERIC NAME: pioglitazone
BRAND NAME: Actos
DRUG CLASS AND MECHANISM: 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, pioglitazone 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.
GENERIC AVAILABLE: no
PRESCRIPTION: yes
PREPARATIONS: Tablets: 15, 30 and 45 mg.
STORAGE: Tablets should be kept at room temperature, 15-30°C (59-86°F).
PRESCRIBED FOR: Pioglitazone 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.
Pioglitazone may be used alone or in combination with metformin, a drug in a different
class of anti-diabetic drugs, that also lowers blood glucose. Since it requires naturally-secreted insulin to be effective, pioglitazone
is not recommended in type I diabetes where the amount of insulin is very low or absent. Nevertheless, pioglitazone is approved for treating
type II diabetes in combination with insulin as well as another class of anti-diabetic drugs, the sulfonylureas.
DOSING: Pioglitazone is prescribed once daily in doses ranging from 15 to 45 mg. Pioglitazone may be taken any time of the day,
with or without meals. If a dose is missed on one day, two doses should not be taken the next day to make up for the missed dose.
DRUG INTERACTIONS: To date, no formal studies to evaluate drug interactions of pioglitazone with other drugs have been
conducted. However, since another thiazolidinedione that is similar to pioglitazone may reduce the effectiveness
of oral contraceptives
(potentially leading to pregnancy), caution should be used when using pioglitazone with an oral contraceptive.
Clinical studies using pioglitazone 15-45mg did not reveal changes in blood levels for the following
drugs: glipizide, digoxin,
warfarin or metformin. In addition, the clotting of blood did not appear to be
changed enough by pioglitazone to require alterations in the doses of the blood thinner, warfarin.
PREGNANCY: There are no adequate studies of pioglitazone in pregnant women. Pioglitazone may be used in pregnancy
if the physician feels the potential risks are justified.
NURSING MOTHERS: It is unknown if pioglitazone is
secreted in breast milk. Therefore, the safety to a nursing infant when the mother is taking pioglitazone is unknown.
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.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
- Drug Interactions - Learn about potential drug interactions you may be exposed to. Drug interactions can occur with prescription drugs, OTC medication, vitamins, herbs, and supplements.
- Diabetes - Learn about type 1 and 2 diabetes (Diabetes Mellitus) symptoms including increased urination, thirst, weight loss, fatigue, nausea, vomiting, skin infections, and blurred vision. Causes and diagnosis information is provided in the information.
- Drugs: What You Should Know About Your Drugs - Find out what you should know about your drugs such as side effects, warnings and precautions, storage information, and if a generic version is as good as the brand name.
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