Rezulin

Generic Name: troglitazone (oral) (troe glih TAH zone)Brand Names: Rezulin

What is troglitazone?

Troglitazone has been withdrawn from the U.S. market.

Troglitazone is an antihyperglycemic agent. It helps your body respond better to insulin and it reduces the amount of sugar produced by your liver. It can help control blood sugar levels.

Troglitazone is used to treat non-insulin-dependent diabetes mellitus (type II diabetes), along with diet and exercise, and insulin, a sulfonylurea, or metformin (Glucophage) if necessary.

Troglitazone may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about troglitazone?

Troglitazone has been withdrawn from the U.S. market.

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.

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.

Troglitazone usually does not cause hypoglycemia (low blood sugar). However, hypoglycemia may occur as a result of skipped meals, excessive exercise, or alcohol consumption. Know the signs and symptoms of hypoglycemia, which include headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of hard candy or glucose tablets with you to treat episodes of low blood sugar.

Avoid alcohol. It lowers blood sugar and may interfere with your diabetes treatment. Troglitazone may decrease the effects of some birth control pills. A higher dose of birth control pills, or another form of birth control, may be necessary while taking troglitazone to prevent pregnancy.

Who should not take troglitazone?

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?

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.

What happens if I miss a dose?

If you forget to take troglitazone at the usual meal, take it at the next meal that same day. If you completely forget to take it one day, skip the missed dose.Never take more than the usual amount of troglitazone in one day to make up for a missed dose. If you take more than the usual amount, call your doctor right away.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a troglitazone overdose are not known but may include headache, dizziness, nausea, diarrhea, and weakness.

What should I avoid while taking troglitazone?

Follow your diet, medication, and exercise routines very closely. Changing any of these factors can effect your blood sugar levels.

Avoid alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

Tell your doctor and dentist that you are taking this medication before you undergo any surgery.

Do not take any over-the-counter cough, cold, allergy, pain, or weight-loss medications without first talking to your doctor.

Troglitazone side effects

Stop taking troglitazone and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

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.

Although troglitazone does not usually cause hypoglycemia (low blood sugar), hypoglycemia may result from skipped meals, excessive exercise, or alcohol consumption. Know the signs and symptoms of hypoglycemia, which include headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of hard candy or glucose tablets with you to treat episodes of low blood sugar.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect troglitazone?

Before taking troglitazone, tell your doctor if you are taking

• cholestyramine (Questran),

• terfenadine (Seldane, Seldane-D), or

• birth control pills.

You may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with troglitazone or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

• Your pharmacist has additional information about troglitazone written for health professionals that you may read.

What does my medication look like?

Troglitazone has been withdrawn from the U.S. market.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 7.06. Revision Date: 2/22/07 2:56:47 PM.