What is Actos used for? Actos, in addition to diet and exercise,
improves blood sugar control in patients with type 2 diabetes (non-insulin dependent
diabetes). Actos can be used alone or in combination with a sulfonylurea, metformin, or
insulin when diet, exercise, and one of these agents or diet, exercise, plus Actos alone
are not are not enough to control blood sugar.

Who should not take Actos?

• Do not take Actos for Type 1 diabetes (juvenile diabetes) or diabetic
  ketoacidosis.
• If you have heart failure, fluid retention or active liver disease your health
  care provider will evaluate you to decide if Actos is right for you.

General Precautions with Actos:

• In drug testing, Actos did not cause liver toxicity or an increase in liver
  enzymes. However, Actos is in the same class of drugs as Rezulin, which has been
  associated with rare but serious liver injury, including liver failure leading to
  transplant or death.

• Because the liver safety profile of Actos is not fully determined yet, your
  doctor will do blood tests that evaluate your liver before starting you on Actos. These
  blood tests should be repeated every two months for the first year, then regularly after
  that.

• Call your health care provider right away if you develop nausea, vomiting,
  stomach pain, a feeling of tiredness, or having no energy, loss of appetite, dark urine,
  or jaundice (yellow coloring of eyes and skin). These may be the symptoms of liver
  problems.

• When taking Actos with insulin or certain other oral diabetes medicines, there is
  a risk of your blood sugar becoming dangerously low. Ask your health care provider about
  symptoms of low blood sugar, conditions that make low blood sugar more likely, and what to
  do if you get it. Make sure to explain to family members.

• If you are a woman who has not reached menopause but have not had menstrual
  periods; you may become pregnant unless you use an effective method of birth control.
  Actos, like other drugs in this class, may cause insulin resistant women to start
  ovulating again.

• Women should tell their doctor if they notice any changes in their monthly
  menstrual cycle.

• During periods of stress on the body, such as fever, trauma, infection, or
  surgery, your medication requirements may change; contact your health care provider
  promptly.

What should I tell my doctor or health care provider?

Women taking oral birth control pills should talk to their health care provider
when taking Actos, because the effectiveness of oral birth control pills can be reduced.

Tell your health care provider if you are trying to become pregnant, are already
pregnant, or are breast-feeding.

Because certain other medications may interact with Actos, review all
medications that you are taking with your health care provider, including those that you
take without a prescription.

What are some possible side effects of Actos? (This list is
NOT a complete list of side effects reported with Actos. Your health care provider can
discuss with you a more complete list of side effects.)

• Cough or cold
• Headache
• Inflammation of the sinuses or throat
• Muscle pain
• Swelling or fluid retention

For more detailed information about Actos, ask your health care provider.

http://www.fda.gov/cder/foi/label/1999/21073lbl.pdf    Actos’ Approved Label

Posted:  3/28/00

Revised: 3/14/01