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Sunday, March 13, 2011

Actos,,Generic Name: pioglitazone (oral) (PYE o GLIT a zone) - Pioglitazone - PubMed Health

Pioglitazone(pye oh gli' ta zone)

Last reviewed: October 1, 2010.

Notice

[Posted 09/17/2010] ISSUE: FDA notified healthcare professionals and patients that the Agency is reviewing data from an ongoing, ten-year epidemiological study designed to evaluate whether pioglitazone (Actos) is associated with an increased risk of bladder cancer. Findings from studies in animals and humans suggest this is a potential safety risk that needs further study. At this time, FDA has not concluded that pioglitazone increases the risk of bladder cancer. Its review is ongoing, and the Agency will update the public when it has additional information.

BACKGROUND: The drug manufacturer, Takeda, conducted a planned analysis of the study data at the five-year mark, and submitted their results to FDA. Overall, there was no statistically significant association between pioglitazone exposure and bladder cancer risk. However, further analyses were also performed looking at how long patients were on pioglitazone and the total amount of the drug they received during that time. An increased risk of bladder cancer was observed among patients with the longest exposure to pioglitazone, as well as in those exposed to the highest cumulative dose of pioglitazone.

RECOMMENDATIONS: Healthcare professionals should continue to follow the recommendations in the drug label when prescribing pioglitazone. Patients should continue taking pioglitazone unless told otherwise by their healthcare professional. Patients who are concerned about the possible risks associated with using pioglitazone should talk to their healthcare professional.

Additional Information for Patients, Information for Healthcare Professionals, and a Data Summary are provided in the Drug Safety Communication. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.

Warning

Pioglitazone and other similar medications for diabetes may cause or worsen congestive heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body). Before you start to take pioglitazone, tell your doctor if you have or have ever had congestive heart failure, especially if your heart failure is so severe that you must limit your activity and are only comfortable when you are at rest or you must remain in a chair or bed. Also tell your doctor if you were born with a heart defect, and if you have or have ever had swelling of the arms, hands, feet, ankles, or lower legs; heart disease; high cholesterol or fats in the blood; high blood pressure; coronary artery disease (narrowing of the blood vessels that lead to the heart); a heart attack; or an irregular heartbeat. Your doctor may tell you not to take pioglitazone or may monitor you carefully during your treatment.

If you develop congestive heart failure, you may experience certain symptoms. Tell your doctor immediately if you have any of the following symptoms, especially when you first start taking pioglitazone or after your dose is increased: large weight gain in a short period of time; shortness of breath; swelling of the arms, hands, feet, ankles, or lower legs; swelling or pain in the stomach; waking up short of breath during the night; needing to sleep with extra pillows in order to breathe while lying down; frequent dry cough; or increased tiredness.

Talk to your doctor about the risks of taking pioglitazone.

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What side effects can this medication cause?

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

You may experience hypoglycemia (low blood sugar) if you are taking this medication in combination with other medications used to treat diabetes. Your doctor will tell you what you should do if you develop hypoglycemia. He or she may tell you to check your blood sugar, eat or drink a food or beverage that contains sugar, such as hard candy or fruit juice, or get medical care. Follow these directions carefully if you have any of the following symptoms of hypoglycemia:

shakiness
dizziness or lightheadedness
sweating
nervousness or irritability
sudden changes in behavior or mood
headache
numbness or tingling around the mouth
weakness
pale skin
hunger
clumsy or jerky movements

If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately.

confusion
seizures
loss of consciousness

Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar):

extreme thirst
frequent urination
extreme hunger
weakness
blurred vision

If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of these symptoms:

dry mouth
upset stomach and vomiting
shortness of breath
breath that smells fruity
decreased consciousness

Pioglitazone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

runny nose and other cold symptoms
headache
muscle pain
tooth or mouth pain
sore throat

Some side effects can be serious. If you experience any of the following symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:

nausea
vomiting
loss of appetite
excessive tiredness
dark urine
yellowing of the skin or whites of the eyes
blurred vision
vision loss

In clinical studies, more people who took pioglitazone developed bladder cancer than people who did not take pioglitazone. Talk to your doctor about the risk of taking this medication.

In clinical studies, more women who took pioglitazone developed fractures, especially of the hands, arms, feet, ankles, and lower legs than women who did not take pioglitazone. Men who took pioglitazone did not have a greater risk of developing fractures than men who did not take the medication. If you are a woman, talk to your doctor about the risk of taking this medication.

Pioglitazone may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Keep all appointments with your doctor, your eye doctor, and the laboratory. Your doctor will probably order regular eye examinations and certain laboratory tests to check your body's response to pioglitazone. Your blood sugar and glycosolated hemoglobin should be checked regularly to determine your response to pioglitazone. Your doctor will also tell you how to check your response to pioglitazone by measuring your blood or urine sugar levels at home. Follow these directions carefully.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

American Society of Health-System Pharmacists, Disclaimer

AHFS® Consumer Medication Information. © Copyright, 2011. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

The following brand names are from RxNorm, a standardized nomenclature for clinical drugs produced by the National Library of Medicine:

Brand names

Actos

Brand names of combination products

Actoplus Met 15/1000 (containing Metformin and pioglitazone)
Actoplus Met 15/500 (containing Metformin and pioglitazone)
Actoplus Met 15/850 (containing Metformin and pioglitazone)
Actoplus Met 30/1000 (containing Metformin and pioglitazone)
Duetact 30/2 (containing glimepiride and pioglitazone)
Duetact 30/4 (containing glimepiride and pioglitazone)

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Type 2 diabetes means the body has a problem with insulin. This causes blood sugar to get too high. Insulin is a hormone, or chemical, made by the body that is needed to change food into energy. When you have type 2 diabetes, your body either does not make enough insulin, or it doesn’t use insulin as well as it should. Diabetes is treated with insulin or oral medicines (pills). This guide can help you talk with your doctor or nurse about pills for type 2 diabetes. It covers: Common kinds of diabetes pills. How well they work for adults with type 2 diabetes. Side effects. Price. The information in this guide comes from a government-funded review of research about pills for type 2 diabetes.

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Type 1 diabetes is a chronic (lifelong) disease that occurs when the pancreas does not produce enough insulin to properly control blood sugar levels.
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Atherosclerosis
Atherosclerosis is a condition in which fatty material collects along the walls of arteries. This fatty material thickens, hardens (forms calcium deposits), and may eventually block the arteries.

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Actos

Generic Name: pioglitazone (oral) (PYE o GLIT a zone)
Brand Names: Actos

What is Actos?

Important information about Actos

You should not use Actos if you are allergic to pioglitazone, if you have severe heart failure, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before taking Actos, tell your doctor if you have congestive heart failure or heart disease, fluid retention, a history of heart attack or stroke, or liver disease.

Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Some women using Actos 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 also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking Actos. Talk with your doctor if you are concerned about this possibility.

Certain oral diabetes medications 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 Actos.

Before taking Actos

You should not use Actos if you are allergic to pioglitazone, if you have severe heart failure, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure you can safely take Actos, tell your doctor if you have any of these other conditions:

congestive heart failure or heart disease;
fluid retention;
a history of heart attack or stroke; or
liver disease.

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

FDA pregnancy category C. It is not known whether Actos will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Actos. It is not known whether pioglitazone passes into breast milk or if it could harm a nursing baby. Do not take Actos without first talking to your doctor if you are breast-feeding a baby.

See also: Actos pregnancy and breastfeeding warnings (in more detail)

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Actos side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Actos: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Actos and call your doctor at once if you have any of these serious side effects:

feeling short of breath, even with mild exertion;
swelling or rapid weight gain;
chest pain, general ill feeling;
nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
blurred vision;
increased thirst or hunger, urinating more than usual; or
pale skin, easy bruising or bleeding, weakness.

Less serious Actos side effects may include:

sneezing, runny nose, cough or other signs of a cold;
headache;
gradual weight gain;
muscle pain; or
tooth problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Actos side effects (in more detail)

What other drugs will affect Actos?

Tell your doctor about all other medicines you use, especially:

bosentan (Tracleer);
delavirdine (Rescriptor);
digoxin (Lanoxin);
gemfibrozil (Lopid);
midazolam (Versed);
morphine (MS Contin, Kadian, Oramorph);
tolbutamide (Orinase);
trimethoprim (Proloprim, Primsol, Bactrim, Cotrim, Septra);
vancomycin (Vancocin, Lyphocin);
amiloride (Midamor), furosemide (Lasix), or triamterene (Dyrenium);
cimetidine (Tagamet) or ranitidine (Zantac);
fluconazole (Diflucan) or ketoconazole (Extina, Ketozole, Nizoral, Xolegal);
nicardipine (Cardene) or nifedipine (Nifedical, Procardia);
procainamide (Procan, Pronestyl, Procanbid), quinidine (Quin-G), or quinine (Qualaquin);
rifampin (Rifater, Rifadin, Rifamate) or rifapentine (Priftin);
a non-steroidal anti-inflammatory drug (NSAID) such as flurbiprofen (Ansaid), ibuprofen (Advil, Motrin), indomethacin (Indocin), mefenamic acid (Ponstel), or piroxicam (Feldene); or
seizure medication such as carbamazepine (Carbatrol, Tegretal), phenytoin (Dilantin), phenobarbital (Solfoton), primidone (Mysoline), and others.

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http://www.drugs.com/actos.html

Actos Side Effects

Please note - some side effects for Actos may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Actos - for the Consumer

Actos Side Effects (in More Detail)

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Actos:

Headache; muscle aches; sore throat; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur when using Actos:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; symptoms of heart failure (eg, shortness of breath; sudden unexplained weight gain; swelling of the hands, ankles, or feet); symptoms of liver problems (eg, dark urine; stomach pain; unexplained nausea, vomiting, or loss of appetite; yellowing of the skin or eyes; sweating); symptoms of low blood sugar (eg, anxiety; chills, increased hunger, headache; increased dizziness or drowsiness; tremors); unusual bone pain; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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