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Rezulin

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Rezulin

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Rezulin

Rezulin Patient Information including How Should I Take

Who should not take troglitazone (Rezulin)?

Do not take troglitazone without first talking to your doctor if you have liver disease. In rare cases, troglitazone has caused severe liver damage resulting in death or liver transplant.

Before taking this medication, tell your doctor if you

  • have kidney disease;
  • have heart failure;
  • have thyroid disease;
  • have type 1 diabetes mellitus (insulin-dependent diabetes);
  • have a serious infection, illness, or injury; or
  • need surgery.

You may need a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Treatment with troglitazone may cause resumption of fertility by allowing for the return of ovulation (production of eggs) in certain women with insulin resistance who were not ovulating before treatment with troglitazone. Therefore, pregnancy may occur and birth control may be a consideration.

Troglitazone is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. However, insulin is usually the drug of choice for controlling diabetes during pregnancy. Do not take troglitazone without first talking to your doctor if you are pregnant.

It is not known whether troglitazone passes into breast milk. Do not take troglitazone without first talking to your doctor if you are breast-feeding a baby.

How should I take troglitazone (Rezulin)?

Take troglitazone exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Take troglitazone with a meal to help increase the amount of medicine your body absorbs.

Your doctor will need to monitor your liver function with blood tests before starting treatment with troglitazone, every month for the first year of treatment, and every 3 months (quarterly) thereafter.

In rare cases, troglitazone has caused severe liver damage resulting in death or liver transplant. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, itching, clay-colored stools, or dark urine. These symptoms may be early signs of liver damage.

Do not take more of this medication than is prescribed for you.

Store troglitazone at room temperature away from moisture and heat.

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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.


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