Actos

Name: Actos

Pioglitazone Side Effects

Common Side Effects of Pioglitazone

Tell your doctor if any of the following side effects become severe or don't go away:

  • Headache
  • Sore throat
  • Gas
  • Muscle pain
  • Sinus pain
  • Weight gain
  • Tooth problems
  • Pain in the arms or legs

Serious Side Effects of Pioglitazone

Contact your physician immediately if you experience any of the symptoms listed in the Warning section or any of the following serious side effects:

  • Vision changes or vision loss
  • Discolored, cloudy, or bloody urine
  • Back or abdominal pain

What is Actos (pioglitazone)?

  • Pioglitazone is an oral drug that reduces the amount of glucose (sugar) in the blood. It is in a class of anti-diabetic drugs called thiazolidinediones that are used in the treatment of type 2 diabetes. The other member in this class is rosiglitazone (Avandia). (Another member of this class, troglitazone or Rezulin, was removed from the market because of liver toxicity.)

Why is Actos (pioglitazone) prescribed to patients?

  • Actos is used for the treatment of type 2 diabetes in adults. It is used along with a healthy diabetic diet, regular exercise, weight control, smoking reduction, and careful monitoring of blood glucose.
  • Actos may be used alone or in combination with metformin (Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet), a drug in a different class of anti-diabetic drugs, that also lowers blood glucose.
  • Actos requires naturally-secreted insulin to be effective so it is not recommended in type 1 diabetes where the amount of insulin is very low or absent.
  • Nevertheless, Actos is approved for treating type 2 diabetes in combination with insulin as well as another class of diabetes drugs, the sulfonylureas, that increases the amount of insulin produced.

Is Actos (pioglitazone) safe to use during pregnancy or while breastfeeding?

  • There are no adequate studies of Actos in pregnant women. Actos may be used in pregnancy if the physician feels the potential risks are justified.
  • It is unknown if Actos is secreted in breast milk. Therefore, the effect of Actos on the nursing infant whose mother is taking Actos is unknown.

What else should I know about Actos (pioglitazone)?

What preparations of Actos (pioglitazone) are available?
  • Tablets: 15, 30 and 45 mg.
How should I keep Actos (pioglitazone) stored?
  • Tablets should be kept at room temperature, 15 C -30 C (59 F -86 F).
How does Actos (pioglitazone) work?
  • Patients with type 2 diabetes cannot make enough insulin, and the cells of their body respond less to the insulin that is produced. Since insulin is the hormone that stimulates cells to remove glucose from the blood, the reduced amount of insulin and its reduced effect cause cells to take up less glucose from the blood and the level of glucose in the blood to rise. Pioglitazone often is referred to as an "insulin sensitizer" because it attaches to the insulin receptors on cells throughout the body and causes the cells to become more sensitive (more responsive) to insulin. As a result, more glucose is removed from the blood, and the level of glucose in the blood falls. At least some insulin must be produced by the pancreas in order for pioglitazone to work. Pioglitazone also lowers the level of glucose in the blood by reducing the production and secretion of glucose into the blood by the liver. In addition, pioglitazone may alter the blood concentrations of lipids (fats) in the blood. Specifically, it decreases triglycerides and increases the "good" (HDL) cholesterol.
When was Actos (pioglitazone) approved by the FDA?
  • Pioglitazone received FDA approval in July 1999.
Reviewed on 11/1/2016 References REFERENCE: FDA Prescribing Information

What is pioglitazone?

Pioglitazone is an oral diabetes medicine that helps control blood sugar levels.

Pioglitazone is for people with type 2 diabetes. Pioglitazone is not for treating type 1 diabetes.

Pioglitazone may also be used for purposes not listed in this medication guide.

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

You should not use this medicine if you have severe or uncontrolled heart failure, active bladder cancer, or diabetic ketoacidosis (call your doctor for treatment with insulin). Pioglitazone is not for treating type 1 diabetes.

Pioglitazone can cause or worsen congestive heart failure. Stop using this medicine and call your doctor at once if you have shortness of breath (even with mild exertion), swelling, or rapid weight gain.

What should I discuss with my healthcare provider before taking pioglitazone?

You should not use this medicine if you are allergic to pioglitazone, or if you have severe or uncontrolled heart failure, active bladder cancer, or diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure pioglitazone is safe for you, tell your doctor if you have:

  • congestive heart failure or heart disease;

  • fluid retention;

  • a history of bladder cancer;

  • a history of heart attack or stroke; or

  • liver disease.

This medication may increase your risk of developing bladder cancer. Talk with your doctor about your specific risk.

Taking pioglitazone may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with pioglitazone.

Follow your doctor's instructions about using pioglitazone if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy.

Some women using pioglitazone have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

Women may be more likely than men to have bone fractures in the upper arm, hand, or foot while taking pioglitazone. Talk with your doctor if you are concerned about this possibility.

It is not known whether pioglitazone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Pioglitazone is not approved for use by anyone younger than 18 years old.

Uses For Actos

Pioglitazone is used with proper diet and exercise to treat high blood sugar levels caused by type 2 diabetes. It may be used alone or with other medicines such as insulin, metformin, or sulfonylurea agents. Pioglitazone works by helping your body use insulin better. This medicine does not help patients who have insulin-dependent or type 1 diabetes.

This medicine is available only with your doctor's prescription.

What are some things I need to know or do while I take Actos?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
  • The chance of getting bladder cancer may be raised when taking this medicine (Actos). Talk with the doctor.
  • Check your blood sugar as you have been told by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Talk with your doctor before you drink alcohol.
  • Follow the diet and workout plan that your doctor told you about.
  • It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor.
  • This medicine may raise the chance of broken bones. The chance may be higher in women. Broken bones were seen after people took this medicine for 1 year. Most of the broken bones happened in the upper arm, hand, or foot. Talk with your doctor about how to keep your bones healthy or if you have any questions.
  • If you are 65 or older, use this medicine (Actos) with care. You could have more side effects.
  • There is a chance of pregnancy in women of childbearing age who have not been ovulating. If you want to avoid pregnancy, use birth control that you can trust while taking this medicine.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (Actos) while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Actos Dosage and Administration

Recommendations for All Patients

Actos should be taken once daily and can be taken without regard to meals.

The recommended starting dose for patients without congestive heart failure is 15 mg or 30 mg once daily.

The recommended starting dose for patients with congestive heart failure (NYHA Class I or II) is 15 mg once daily.

The dose can be titrated in increments of 15 mg up to a maximum of 45 mg once daily based on glycemic response as determined by HbA1c.

After initiation of Actos or with dose increase, monitor patients carefully for adverse reactions related to fluid retention such as weight gain, edema, and signs and symptoms of congestive heart failure [see Boxed Warning and Warnings and Precautions (5.5)].

Liver tests (serum alanine and aspartate aminotransferases, alkaline phosphatase, and total bilirubin) should be obtained prior to initiating Actos. Routine periodic monitoring of liver tests during treatment with Actos is not recommended in patients without liver disease. Patients who have liver test abnormalities prior to initiation of Actos or who are found to have abnormal liver tests while taking Actos should be managed as described under Warnings and Precautions [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

Concomitant Use with an Insulin Secretagogue or Insulin

If hypoglycemia occurs in a patient co-administered Actos and an insulin secretagogue (e.g., sulfonylurea), the dose of the insulin secretagogue should be reduced.

If hypoglycemia occurs in a patient co-administered Actos and insulin, the dose of insulin should be decreased by 10% to 25%. Further adjustments to the insulin dose should be individualized based on glycemic response.

Concomitant Use with Strong CYP2C8 Inhibitors

Coadministration of Actos and gemfibrozil, a strong CYP2C8 inhibitor, increases pioglitazone exposure approximately 3-fold. Therefore, the maximum recommended dose of Actos is 15 mg daily when used in combination with gemfibrozil or other strong CYP2C8 inhibitors [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

Actos Overview

Actos is a prescription medication used to treat type 2 diabetes. Actos belongs to a group of drugs called thiazolidinediones. It lowers blood sugar levels by increasing the body's response to insulin. 

This medication comes in tablet form and is taken once a day, with or without food. Common side effects include runny or stuffy nose, headaches, sinus infections.   

Uses of Actos

Actos is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Actos Overdose

If you take too much Actos, call your doctor or go to the nearest hospital emergency room right away.

 

Dosing & Uses

Dosage Forms & Strengths

tablet

  • 15mg
  • 30mg
  • 45mg

Type 2 Diabetes Mellitus

Indicated as monotherapy or with insulin or insulin secretagogues

15-30 mg PO with meal qDay initial; may increase dose by 15 mg with careful monitoring to 45 mg qDay maximum

Monitor ALT at start of treatment, qMonth for 12 months, q3Months thereafter

Dosage Modification

Coadministration with insulin secretagogue (eg, sulfonylurea): Decrease insulin secretagogue dose

Coadministration with insulin: Decrease insulin dose by 10-25%

Coadministration with strong CYP2C8 inhibitors (eg, gemfibrozil): Limit maximum pioglitazone dose to 15 mg qDay

X-Linked Adrenoleukodystrophy (Orphan)

Hydroxypioglitazone: Orphan designation for treatment of X-linked adrenoleukodystrophy

Sponsor

  • Minoryx Therapeutics S.L.; TecnoCampus Mataro-Maresme. TCM3 602, Av. Ernest Lluch, 32; MatarĂ³, Spain

Not recommended

How should I take Actos?

Take Actos exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Actos is usually taken once daily. You may take the medicine with or without food.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating.

Keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency. If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

Use Actos regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Actos is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Actos dosing information

Usual Adult Dose for Diabetes Type 2:

Initial dose:
-Patients without congestive heart failure: 15 mg or 30 mg orally once a day
-Patients with congestive heart failure (New York Heart Association [NYHA] Class I or II): 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 can be taken without regard to meals.

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

In Summary

Common side effects of Actos include: upper respiratory tract infection, edema, and hypoglycemia. Other side effects include: cardiac failure, exacerbation of congestive heart failure, bone fracture, headache, and pharyngitis. See below for a comprehensive list of adverse effects.

Administrative Information

LactMed Record Number

215

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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