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|Actos

PIOGLITAZONE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Actos

Category

• Antidiabetic agent

Description

Pioglitazone (pye-oh-GLI-ta-zone) is used to treat a certain type of diabetes mellitus (sugar diabetes) called type 2 diabetes. It may be used alone, with insulin, or with metformin or another type of oral diabetes medicine called a sulfonylurea. Pioglitazone is to be used when diet and exercise plus another diabetes medicine do not result in good blood sugar control.

This medicine is available only with your doctor"s prescription, in the following dosage form:

• Oral
• Tablets (U.S. and Canada)

Before Using This Medicine

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 pioglitazone, the following should be considered:

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

Pregnancy—Pioglitazone 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 pioglitazone. 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. Pioglitazone should be used during pregnancy only if the potential benefit outweighs the potential risk. 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 pioglitazone passes into the breast milk of humans. However, pioglitazone 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 pioglitazone 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. In a post-marketing safety study, patients over 64 years of age were shown to be more affected by heart failure requiring them to be hospitalized when compared with others in the study.

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 pioglitazone, it is especially important that your health care professional know if you are taking the following:

• Ketoconazole—Use of this medicine with pioglitazone may decrease the effect of pioglitazone

Other medical problems—The presence of other medical problems may affect the use of pioglitazone. Make sure you tell your doctor if you have any other medical problems, especially

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

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

• Problems with fluid retention or swelling—May make these conditions worse

• Hypersensitivity to pioglitazone or any ingredients in pioglitazone.

Proper Use of This Medicine

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.

Pioglitazone may be taken with or without food.

Certain women may be at an increased risk for pregnancy while taking pioglitazone. Adequate contraception is recommended.

Dosing—The dose of pioglitazone will be different for different patients. Follow your doctor"s orders or the directions on the label . 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:
    • Pioglitazone alone:
      • Adults: At first, the dose is 15 or 30 milligrams (mg) once daily with or without meals. Your doctor may later increase your dose up to 45 mg once daily.
      • Children: Use and dose must be determined by your doctor.
    • Pioglitazone with insulin:
      • Adults: At first, the dose is 15 or 30 mg once daily with or without meals.
      • Children: Use and dose must be determined by your doctor.
    • Pioglitazone with metformin:
      • Adults: At first, the dose is 15 or 30 mg once daily with or without meals.
      • Children: Use and dose must be determined by your doctor.
    • Pioglitazone with a sulfonylurea:
      • Adults: At first, the dose is 15 or 30 mg once daily with or without meals.
      • Children: Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as you remember. However, if you do not remember it until it is time for your next dose, 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.
• 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.
• Store away from heat and direct light.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

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.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects

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 pioglitazone 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 during pregnancy in patients with diabetes .
• 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.
• Symptoms of fluid retention—Know what to do if you start to retain fluid. Fluid retention may worsen or lead to heart problems.
• This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when you take pioglitazone with other medicines that can lower blood sugar, such as insulin, metformin, or a sulfonylurea. Low blood sugar also can 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 .

Side Effects of This Medicine

Side Effects of This Medicine

Less common

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

Developed: 1/20/2000
Revised: 09/03/2004

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