• Antidiabetic agent

Troglitazone ( TROE-glit-a-zone) is used to treat a certain type of diabetes mellitus (sugar diabetes) called type 2 diabetes. It may be used with insulin, or with a type of oral diabetes medicine called a sulfonylurea, or with a sulfonylurea and metformin.

This medicine was withdrawn from the U.S. market in March 2000.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For troglitazone, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to troglitazone. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Troglitazone has not been studied in pregnant women. However, it is easier during pregnancy to control your blood sugar by using injections of insulin, rather than by taking troglitazone. Close control of your blood sugar can reduce the chance of your baby gaining too much weight, having birth defects, or having high blood sugar before birth. Be sure to tell your doctor if you plan to become pregnant or you think you are pregnant.

Breast-feeding—It is not known whether troglitazone passes into the breast milk of humans. However, troglitazone is not recommended during breast-feeding.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of troglitazone in children with use in other age groups.

Older adults—This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking troglitazone, it is especially important that your health care professional know if you are taking any of the following:

• Cholestyramine (e.g., Questran)—Use of this medicine with troglitazone may decrease the effects of troglitazone; these medicines should not be used together

• Oral contraceptives (birth control pills) containing estrogen or norethindrone—Use of troglitazone with oral contraceptives may prevent oral contraceptives from working properly, increasing the chance of pregnancy
• Terfenadine (e.g., Seldane)—Use of troglitazone with terfenadine may decrease the effects of terfenadine; these medicines should not be used together

• Diabetic ketoacidosis (ketones in the blood) or
• Type 1 diabetes—Insulin is needed to control these conditions

• Heart disease or
• Liver disease—Troglitazone may make these conditions worse

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

This medicine should be taken with a meal.

Dosing—

The dose of troglitazone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of troglitazone. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For type 2 diabetes:
    • Troglitazone with insulin:
      • Adults: At first, the dose is 200 mg once a day with a meal. After two to four weeks, the dose may be increased to 400 mg once a day with a meal.
      • Children: Use and dose must be determined by your doctor.
    • Troglitazone with a sulfonylurea:
      • Adults: At first, the dose is 200 mg once a day with a meal. After two to four weeks the dose may be increased, if needed.
      • Children: Use and dose must be determined by your doctor.
    • Troglitazone with a sulfonylurea and metformin:
      • Adults: The dose is 400 mg once a day with a meal.
      • Children: Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, and you remember it the same day, take it with the next meal. However, if you do not remember it until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

If you experience abdominal or stomach pain, dark urine, loss of appetite, nausea or vomiting, unusual tiredness or weakness, or yellow eyes or skin, check with your doctor immediately. These may be symptoms of liver problems.

Your doctor will want to check your progress at regular visits, especially during the first year you take this medicine. Your doctor will need to check on a regular basis to make sure your liver is working properly.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines during the time you are taking troglitazone unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, diabetic patients may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when troglitazone is taken with other medicines, such as insulin or sulfonylureas, that can lower blood sugar. Low blood sugar can also occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.

Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, nondiet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and amount); ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if either of the following side effects occur:

• Rare
  • Yellow eyes or skin 
  
  

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Back pain;  infection;  pain 
  
  

• Less common
  • Painful or increased urination;  swelling of feet or lower legs 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Dizziness;  headache;  nausea;  unusual tiredness or weakness 
  
  

• Less common
  • Diarrhea;  sore throat;  stuffy nose 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.