Generic Name: Pioglitazone Brand Name(s): Generics only. No brands available.

Uses

What is Pioglitazone used for?

Pioglitazone is a diabetes drug (thiazolidinedione-type, also called “glitazones”) used along with a proper diet and exercise program to control high blood sugar in patients with type 2 diabetes. It works by helping to restore your body’s proper response to insulin, thereby lowering your blood sugar.

Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

Pioglitazone is used either alone or in combination with other diabetes medications (such as metformin or a sulfonylurea such as glyburide).

How should I take Pioglitazone?

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Dosage is based on your medical condition, response to treatment, and if you are taking other diabetes drugs. Your doctor will adjust your dose based on your blood sugar to find the best dose for you. Follow your doctor’s directions carefully.

Take this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.

If you are already taking another diabetes drug (such as metformin or a sulfonylurea), follow your doctor’s directions carefully for stopping/continuing the old drug and starting this medication. Carefully follow the medication treatment plan, meal plan, and exercise program your doctor has recommended.

Check your blood sugar regularly as directed by your doctor. Keep track of the results, and share them with your doctor. Tell your doctor if your blood sugar measurements are too high or too low. Your dosage/treatment may need to be changed. It may take up to 2 to 3 months before the full benefit of this drug takes effect.

How do I store Pioglitazone?

Pioglitazone is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Pioglitazone in the bathroom or the freezer. There may be different brands of Pioglitazone that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Pioglitazone down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Pioglitazone?

Before taking pioglitazone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (such as congestive heart failure, chest pain), liver disease, fluid in your lungs, swelling (edema), anemia, a certain eye problem (macular edema), bladder cancer.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase the risk of developing low blood sugar.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because increased stress may require a change in your treatment plan, medications, or blood sugar testing.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Pioglitazone may increase the risk of bone fracture in women (usually in the upper arm, hand, or foot).

Pioglitazone can cause changes in the menstrual cycle (promote ovulation) and increase the risk of becoming pregnant. Consult your doctor or pharmacist about the use of reliable birth control while using this medication.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Your doctor may substitute insulin for this drug during your pregnancy. Follow all instructions carefully.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Pioglitazone during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Pioglitazone. Pioglitazone is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Pioglitazone?

Sore throat, muscle pain, weight gain, or tooth problems may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: new/worsening vision problems (such as blurred vision), bone fracture, reddish-colored urine, urgent need to urinate, pain while urinating.

Pioglitazone may rarely cause liver disease. Tell your doctor right away if you develop symptoms of liver disease, including: dark urine, yellowing of eyes/skin, persistent nausea/vomiting, stomach/abdominal pain.

Pioglitazone does not usually cause low blood sugar (hypoglycemia). Low blood sugar may occur if this drug is prescribed with other diabetes medications (such as insulin or a sulfonylurea). Low blood sugar is more likely if you drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don’t have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Pioglitazone?

Other medications can affect the removal of pioglitazone from your body, which may affect how pioglitazone works. Examples include gemfibrozil, rifamycins including rifampin, among others.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.

Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Pioglitazone may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Pioglitazone?

Pioglitazone may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Pioglitazone?

Pioglitazone may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Pioglitazone.

What is the dose of Pioglitazone for an adult?

Usual Adult Dose for Diabetes Type 2

-Patients without congestive heart failure:

Initial dose: 15 mg or 30 mg orally once a day

-Patients with congestive heart failure (New York Heart Association [NYHA] Class I or II):

Initial dose: 15 mg orally once a day

Maintenance dose: 15 mg to 45 mg orally once a day based on glycemic response as determined by HbA1c

Maximum dose: 45 mg orally once a day

Comments:

-This drug exerts its antihyperglycemic effect only in the presence of endogenous insulin and therefore is not expected to be effective in patients with type 1 diabetes mellitus or diabetic ketoacidosis.

-Patients concomitantly receiving an insulin secretagogue or insulin may need to reduce the dose of the insulin secretagogue or insulin if hypoglycemia occurs.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Use with caution in patients with liver disease.

-Obtain liver function tests (ALT, AST, alkaline phosphatase, and total bilirubin) prior to initiating therapy.

-Promptly perform liver function tests if symptoms suggestive of liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice develop.

-If ALT is greater than 3 times the upper limit of normal (ULN), interrupt therapy and investigate cause.

-Do not restart therapy if ALT is greater than 3 x ULN and total bilirubin greater than 2 x ULN without alternative etiologies as there is a risk for severe drug-induced liver injury.

-Treatment may be restarted with caution for patients with lesser elevations of ALT or bilirubin and an alternative probable cause.

Dose Adjustments

Concomitant use with an insulin secretagogue (e.g., sulfonylurea): If hypoglycemia occurs, the dose of the insulin secretagogue should be reduced.

Concomitant use with insulin: If hypoglycemia occurs, the dose of insulin should be reduced by 10% to 25%. Additional adjustments to the insulin dose should be individualized based on glycemic response.

Concomitant use with Gemfibrozil or Other Strong CYP450 2C8 Inhibitors:

Maximum recommended daily dose: 15 mg

For Patients with Congestive Heart Failure (NYHA Class I or II)

Initial dose: 15 mg orally once a day

Other Comments

Administration advice:

-Take orally once a day with or without meals

Storage requirements:

-Protect from light, moisture and humidity

General:

-This drug is contraindicated for use in patients with NYHA Class III or IV Heart Failure (HF), not recommended in patients with symptomatic HF, and should be initiated at reduced doses in patients with NYHA Class I or II HF.

-This drug should be used cautiously in patients with liver disease.

-This drug should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

-The US FDA has released an updated review evaluating the risk of bladder cancer and it concludes that use of this drug may be linked to an increased risk of bladder cancer; while a 10-year epidemiologic study did not find an increased risk, other studies have shown risk. This drug should not be used in patients with active bladder cancer and should be used very carefully in patients with a history of bladder cancer.

Monitoring:

-Monitor closely for signs and symptoms of heart failure (e.g., weight gain, edema), especially with concomitant insulin use.

-Perform liver function tests (LFTs) prior to initiation; if symptoms suggestive of liver injury develop, LFTs should be performed promptly; routine monitoring of LFTs in patients without liver disease is not recommended

-Monitor glycemic control

-Assess and maintain bone health according to current standards, especially in female patients

-Patients with diabetes should have regular eye exams by an ophthalmologist

Patient advice:

-This drug may cause edema; patients experiencing rapid weight gain, shortness of breath or other symptoms of heart failure should notify their health care professional promptly.

-Premenopausal anovulatory women may be at risk for pregnancy with use of this drug; pregnancy risk should be discussed and adequate contraception recommended if necessary.

-Patients should be told to stop taking this medication and seek medical attention for unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or dark urine as they may be signs of hepatotoxicity.

-Patients should be instructed to report blood or red color in the urine, new or worsening urge to urinate, or pain when urinating as they may be signs of bladder cancer.

-Patients should be informed about the risks of hypoglycemia, its symptoms, the conditions that might predispose them to develop it, and treatment.

-Patients should speak with their health care provider during periods of stress such as fever, trauma, infection, or surgery, as their diabetes management may need to be changed.

What is the dose of Pioglitazone for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Pioglitazone available?

Pioglitazone is available in the following dosage forms and strengths:

  • Oral tablet

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Pioglitazone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: April 11, 2018 | Last Modified: April 11, 2018