Tablets: 15 mg, 30 mg, and 45 mg

What is ACTOS?
What is type 2 diabetes?
Why is it important to control type 2 diabetes?
How does ACTOS help treat type 2 diabetes?
Will ACTOS increase my risk of having a heart attack or stroke?
What are the possible serious side effects of ACTOS?
What should I discuss with my health professional before taking ACTOS?
How soon will ACTOS begin to work?
How should I take ACTOS?
What should I do if I miss a dose?
Do I still need to test my blood glucose while using ACTOS?
What other routine laboratory tests are recommended?
Can I take ACTOS with other diabetes drugs?
Will ACTOS interfere with other drugs?
Can ACTOS increase my risk for pregnancy?
What else can I do to help control type 2 diabetes?
Who should not use ACTOS?
How should I store ACTOS?
Where can I find more information about ACTOS?

What is ACTOS?

ACTOS is a clinically proven, once-a-day medicine that belongs to a class of oral diabetes drugs called thiazolidinediones (THIGH-ah-ZO-li-deen-DYE-owns). Thiazolidinediones are also called insulin sensitizers because they treat type 2 diabetes by helping your body better use insulin. ACTOS comes in tablets, is always taken once a day, and, along with healthy eating and physical activity, helps lower blood glucose (sugar) levels.

What is type 2 diabetes?

Type 2 diabetes (formerly called non–insulin-dependent diabetes mellitus or adult-onset diabetes) occurs when the body does not produce enough insulin or cannot properly use the insulin it makes to control blood sugar. Insulin allows sugar to enter the cells of your body. Once inside the cells, sugar is used as a source of energy. If your body is resistant to the effects of insulin, a condition known as insulin resistance, and if it cannot make enough insulin to overcome that resistance, sugar builds up in the blood (hyperglycemia).

Why is it important to control type 2 diabetes?

It is important to control type 2 diabetes because the buildup of sugar in the blood, if not controlled, can lead to serious medical problems such as kidney damage, amputation, heart disease, and blindness.

How does ACTOS help treat type 2 diabetes?

ACTOS, along with healthy eating and physical activity, works by treating insulin resistance, an important defect of type 2 diabetes. ACTOS helps your body use insulin more effectively by making your cells more sensitive to insulin. That is why it is called an insulin sensitizer. It does not cause your body to produce more insulin; instead, it helps your body respond better to insulin’s effects.

Will ACTOS increase my risk of having a heart attack or stroke?

In clinical studies, ACTOS did not increase the risk of having a heart attack or stroke. The ACTOS product information includes FDA-reviewed data from a study of more than 5,000 high-risk patients with a history of macrovascular disease (ie, recent heart attack, stroke, bypass surgery, etc). In this study, there was no difference in the number of macrovascular events (such as heart attacks or strokes) between patients taking ACTOS and those not taking ACTOS. ACTOS is not for everyone. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause or worsen congestive heart failure. Please see Important Safety Information below.

What are the possible serious side effects of ACTOS?

Fluid buildup (edema) can occur when taking ACTOS or other products in this class, and can lead to congestive heart failure (CHF). ACTOS is not recommended in certain patients with heart failure. CHF is different than a heart attack or stroke. It is a condition in which the heart cannot pump blood as effectively as it should. CHF is a serious condition that, while often treatable, requires close monitoring and care by your physician.

ACTOS was generally well tolerated in clinical trials. The most common side effects reported by people taking ACTOS included symptoms of upper respiratory tract infection, headache, sinusitis, muscle soreness, tooth disorder, and sore throat. Occasionally, blood sugar levels increased during clinical trials. This occurred less frequently with ACTOS than with placebo (an inactive comparison pill). As with other insulin sensitizers, weight gain may occur. In addition, mild-to-moderate swelling (edema) and a decrease in blood count (anemia) may occur. Low blood sugar was observed in a few patients who took ACTOS with insulin or with other oral diabetes drugs. Very rarely, some patients have experienced visual changes while taking ACTOS.

What should I discuss with my health professional before taking ACTOS?

ACTOS is not for everyone. You should talk to your health professional if you have a history of congestive heart failure, liver problems, or swelling (edema), or if you are pregnant, intend to become pregnant, or are breast-feeding. ACTOS can cause fluid retention or swelling, which may lead to or worsen heart failure. It is also important to tell your health professional if you are taking other prescription drugs or over-the-counter products.

How soon will ACTOS begin to work?

Your blood sugar levels may be significantly reduced in as quickly as 2 weeks, though the full effect of ACTOS may take several more weeks to be seen. If you do not respond adequately to your starting dose of ACTOS, your health professional may increase your daily dose to improve your blood sugar control.

How should I take ACTOS?

ACTOS only needs to be taken once a day. Food does not change how ACTOS works, so you can take it with or without meals. To help you remember to take ACTOS, it is a good idea to take it at the same time every day.

What should I do if I miss a dose?

If you miss the timing of your daily dose, take ACTOS as soon as you remember within the same day. If you miss a day, do not take a double dose the next day to make up for it.

Do I still need to test my blood sugar while using ACTOS?

Yes. You should test your blood sugar as often as your health professional recommends.

What other routine laboratory tests are recommended?

It is important to have your blood glucose and glycosylated hemoglobin (A1C), a measure of your average blood sugar levels over 2 to 3 months, checked regularly by your health professional. You will also need to have blood tests to check for serious or active liver disease prior to starting ACTOS therapy, and periodically thereafter per the clinical judgment of your health professional.

While taking ACTOS, call your health professional immediately if:

You experience an unusually rapid increase in weight or mild to moderate swelling (edema) or develop shortness of breath or other symptoms of heart failure.
You experience unexplained nausea, vomiting, stomach pain, fatigue, anorexia, or dark urine.

Can I take ACTOS with other diabetes drugs?

Only your health professional can determine which drugs are best for your type 2 diabetes. If healthy eating, physical activity, and a single drug are not enough to control your diabetes, ACTOS can be taken in combination with certain other medicines (sulfonylureas, metformin, or insulin). Because ACTOS works differently than any of these drugs, combining ACTOS with another diabetes drug can provide additional improvements in your blood sugar levels. ACTOS is not likely to cause low blood sugar when taken alone, because it does not cause your body to produce more insulin. However, people taking ACTOS with sulfonylureas or insulin may be at increased risk for low blood sugar, and an adjustment in the dose of sulfonylurea or insulin may be needed.

Will ACTOS interfere with other drugs?

ACTOS can be taken with other common prescription drugs, such as digoxin and warfarin, and other diabetes drugs such as glipizide (a sulfonylurea) and metformin. Always inform your health professional about any other prescription drugs or over-the-counter products you may be taking.

Can ACTOS increase my risk for pregnancy?

If you are a premenopausal woman who is not ovulating, you should know that ACTOS might increase your risk of pregnancy by causing you to ovulate. Therefore, you may need to consider birth control options. However, women using oral contraceptives should talk with their health professionals, as they may be at increased risk for pregnancy if appropriate contraceptive methods or adjustments are not used.

What else can I do to help control type 2 diabetes?

To help control type 2 diabetes, prescription drugs such as ACTOS should be used along with nutritional counseling, weight reduction as needed, and physical activity.

Who should not use ACTOS?

Certain patients with heart failure should not start taking ACTOS. ACTOS should not be taken by people with active liver disease or jaundice (yellowing of the skin), people with type 1 diabetes, women who are pregnant or breast-feeding, or people who are allergic to ACTOS or any of its ingredients. ACTOS should not be used for the treatment of diabetic ketoacidosis (a complication of diabetes in which acids called ketones build up in the blood). ACTOS should be used with caution in people with swelling (edema).

How should I store ACTOS?

Store ACTOS at room temperature, in a container that is tightly closed, and away from moisture and humidity.

Where can I find more information about ACTOS?

This is a summary of some of the most important information about ACTOS. If you have any further questions about type 2 diabetes or ACTOS, you should talk to your health professional
 

SIDE EFFECTS: Sore throat, muscle pain, or tooth problems may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling, unexplained rapid weight gain, trouble breathing, unusual fatigue, fast/pounding heartbeat, changes in menstrual cycles. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: dark urine, yellowing of eyes/skin, persistent nausea/vomiting, stomach/abdominal pain. This medication usually does not cause low blood sugar (hypoglycemia), but this effect may occur if you do not consume enough calories (from food, juices, fruit, etc.). The symptoms include chills, cold sweat, dizziness, drowsiness, shaking, rapid heart rate, weakness, headache, fainting, tingling of the hands or feet, or hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you are in a situation where you don’t have these reliable forms of glucose, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule and do not skip meals. 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 immediately. Your medication dosage may need to be increased. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately.

NOTES: Do not share this medication with others. It is recommended you attend a diabetes education program to understand diabetes and all the important aspects of its treatment including meals/diet, exercise, personal hygiene, medications and getting regular eye, foot and medical exams. Keep all medical appointments. Laboratory and/or medical tests (e.g., liver and kidney function tests, fasting blood glucose, hemoglobin A1c, complete blood counts, CPK levels) will be performed to monitor for side effects and response to therapy. Regularly check your blood or urine for sugar, as directed by your doctor or pharmacist.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested, and you may need regular eye exams. It is important that you not miss any scheduled visits to your doctor.Your medication needs may change if you become sick or injured, if you have a serious infection, or if you have any type of surgery. Your doctor may want you to stop taking Actos for a short time if any of these situations affect you.

Take care not to let your blood sugar get too low, causing hypoglycemia. You may have hypoglycemia if you skip a meal, exercise too long, drink alcohol, or are under stress.Know the signs of low blood sugar (hypoglycemia) and how to recognize them:
hunger, headache, confusion, irritability;drowsiness, weakness, dizziness, tremors;sweating, fast heartbeat;seizure (convulsions); orfainting, coma (severe hypoglycemia can be fatal).

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

After 24 weeks, only the Actos group saw reductions in carotid IMT. After 12 weeks, thickness decreased an average of 0.033 millimeters, and after 24 weeks the decrease reached an average of 0.054 millimeters. In addition, insulin resistance was significantly improved in the Actos group versus the Amaryl group.

Why is this study important to people with type 2 diabetes?

This study proves that lowering of glucose alone is not enough to reduce the risk for myocardial infarction. Type 2 diabetes is a very complex disease, and blood glucose deterioration is only one half of it. The lack of insulin effects at the inner layer of the blood vessels (that have nothing to do with glucose lowering) leads to this increased cardiovascular risk. To restore these effects, the treatment should focus on a reduction of insulin resistance. Basically this can be achieved by diet and exercise, but our study shows that Actos is a very potent drug not only in terms of glucose lowering but also in improving the situation in the blood vessels.

What else can type 2s do to improve their IMT?

Regular exercise and maintenance of a normal body weight is the best and cheapest way to reduce IMT. Next to Actos, the lipid-lowering drug class of statins has been shown to also have a beneficial effect on IMT. Preliminary results from a currently running study at our institute indicate that the combination of Actos with a statin shows a synergistic effect on cardiovascular risk markers, i.e., the combination seems to be better than the single drugs in this respect.

A new study published in today’s issue of Diabetes Care demonstrated that ACTOS improved components of diabetic dyslipidemia to a significantly greater extent than Avandia. Specifically, the results indicated that treatment with ACTOS lowered triglycerides (a type of lipid, or fat, found in food and the body), increased HDL-C (”good” cholesterol), and improved LDL-C (”bad” cholesterol) particle concentration and particle size. These differences were independent of blood glucose control and occurred without the use of a traditional lipid-lowering statin medication.

Diabetic dyslipidemia is a condition commonly found in people with type 2 diabetes and is an important risk factor for cardiovascular disease, the leading cause of death for people with type 2 diabetes. Diabetic dyslipidemia is characterized by increased triglycerides and decreased HDL-C. People with diabetic dyslipidemia also tend to have normal levels of LDL-C, but smaller, denser LDL-C particles that are likely to contribute to cholesterol build-up in arteries.

“This study provides important insight into the relative impact of each drug on important cardiovascular risk markers,” noted principal investigator Ronald B. Goldberg, M.D., professor of Medicine and Associate Director of the Diabetes Research Institute at the University of Miami Miller School of Medicine. “The results demonstrate a clear difference between ACTOS and Avandia on their effects on diabetic dyslipidemia, with ACTOS lowering triglycerides and raising HDL-C to a greater extent than Avandia.”

Study Design

This 24-week prospective, randomized, multicenter, double-blind clinical trial enrolled 802 people with type 2 diabetes (treated with diet alone or oral monotherapy) and dyslipidemia (not treated with any lipid-lowering medications).

Following a four-week “washout” period where patients discontinued their current diabetes medication and received a placebo, patients were randomized to receive either 30 mg of ACTOS(R) (pioglitazone HCl) once daily for 12 weeks followed by 45 mg of ACTOS once daily for the remainder of the study, or 4 mg of Avandia(R) (rosiglitazone maleate) once a day for 12 weeks followed by 4 mg of Avandia twice daily for the remainder of the study. These represent the maximally effective therapeutic doses for both medications.

“By eliminating other factors such as statins to control lipids and other medications to control blood glucose levels, we obtained a clear assessment of the blood sugar and lipid effects of both drugs,” added Dr. Goldberg.

Results

The study showed that blood glucose control, which was measured by A1C (a measure of blood glucose over a several-month period), was significantly improved in both ACTOS- and Avandia-treated patients with comparable changes from baseline. At baseline, average A1C scores were 7.6 percent in the ACTOS group and 7.5 percent in the Avandia group. Following treatment, average A1C was reduced by 0.7 percent and 0.6 percent respectively (P=NS), and mean A1C for both treatment groups was below the ADA goal of less than 7 percent.

Additionally, the study demonstrated that ACTOS and Avandia differed significantly in their effects on blood lipids:

* triglyceride levels decreased 12.0 percent in the ACTOS patients, and rose 14.9 percent in the Avandia patients (P<0.001).

* HDL-C rose 14.9 percent in the ACTOS patients, whereas it increased 7.8 percent in the Avandia patients (P<0.001).

* LDL-C particle concentration was reduced with ACTOS and increased with Avandia (P<0.001). LDL-C particle size increased more with ACTOS (P=0.005).

Total cholesterol (TC) and LDL-C increased with both drugs, but to a lesser extent with ACTOS. TC and LDL-C rose 15.9 and 23.3 percent, respectively, in the Avandia patients; they increased 5.7 percent and 15.7 percent, respectively, in the ACTOS patients (TC: P<0.001; LDL-C: P=0.002).

“Our knowledge regarding the association between type 2 diabetes and cardiovascular disease, which can be referred to as ‘CardioDiabetes,’ continues to grow,” said Robert Spanheimer, M.D., medical director for diabetes and metabolism at Takeda Pharmaceuticals North America. “Many factors can contribute to the increased risk of cardiovascular disease in people with diabetes, including multiple lipid abnormalities. It is important to understand the impact medications can have on individual lipid parameters. This study underscores the potential benefits of ACTOS beyond glycemic control in improving diabetic dyslipidemia in patients with type 2 diabetes. These findings require further research in order to determine whether the results reported here may affect cardiovascular risk.”

ACTOS(R) (pioglitazone HCl) Avandia(R) (rosiglitazone maleate) are insulin sensitizers belonging to the thiazolidinedione (TZD) class of oral anti-diabetes medications that have been approved by the Food and Drug Administration to improve blood glucose control in type 2 diabetes as an adjunct to diet and exercise.

About ACTOS

ACTOS works by directly targeting insulin resistance, a condition in which the body does not effectively use the insulin it produces to control blood glucose levels. ACTOS is taken once daily as an adjunct to diet and exercise, and is approved for use as monotherapy to lower blood glucose and in combination therapy with insulin, sulfonylureas or metformin.

Additional Information

ACTOS is not for everyone. ACTOS can cause fluid retention that may lead to or worsen heart failure, so tell your doctor if you have a history of these conditions. Talk to your doctor immediately if you experience rapid weight gain, fluid retention, or shortness of breath while taking ACTOS. If you have moderate to severe heart failure, ACTOS is not recommended. Your doctor should perform a blood test to check for liver problems before you start ACTOS and periodically thereafter.

Do not take ACTOS if you have active liver disease. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or yellowing of the skin. If you are of childbearing age, talk to your doctor before taking ACTOS as it could increase your chance of becoming pregnant. Some people taking ACTOS may experience flu-like symptoms, mild to moderate swelling of legs and ankles, and anemia. When taking ACTOS with insulin or sulfonylureas, you may be at risk for low blood glucose.

While ACTOS may confer some lipid benefits, ACTOS is not indicated to treat lipid disorders and should not be used as a substitute for lipid-lowering therapy.

Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers–through medicines and information–for some of the world’s most urgent medical needs. Additional information about Lilly is available on http://www.cesaonline.com

Takeda Pharmaceuticals North America, Inc.

Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets oral diabetes and cholesterol-lowering treatments, and through the Takeda Global Research & Development Center, Inc. the company has a robust pipeline with compounds in development for diabetes, sleep, cardiovascular disease and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit http://www.cesaonline.com .

ACTOS is a registered trademark of Takeda Pharmaceutical Company Limited and used under license by Takeda Pharmaceuticals North America, Inc. and Eli Lilly and Company. Please visit the ACTOS Web site at www.CesaOnline.com for complete Prescribing Information. The brand names included in this piece are properties of their respective owners.

Contact your doctor immediately if you experience the following side effects: bloating or swelling of ankles, feet, or hands; chest pain; rapid weight gain; shortness of breath; fatigue; unexplained nausea or vomiting; stomach pain; loss of appetite; unusual thirst; unusual amount of urine; dark urine; or yellowing of the skin or eyes. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist (discount online pills,worldwide shipping).

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Additional information

Follow the dietary plan provided by your doctor. Carry an identification card at all times that says you are diabetic. Monitor your blood sugar levels regularly according to your doctor’s directions. If your blood sugar level is often higher than it should be and you are taking this medicine according to directions, check with your doctor (low cost actos).

Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this product out of the reach of children. If using this medicine for an extended period of time, obtain refills before your supply runs out (order actos now).

Drug interactions

Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Some medicines or medical conditions may interact with this medicine. Inform your doctor or pharmacist of all prescription and over-the-counter medicine that you are taking.

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This medicine is used to treat type 2 diabetes by reducing the resistance your body has to insulin. It is used either alone or in combination with other anti-diabetes medicines, including metformin or insulin, as part of a diet and exercise program.

Before using

Additional monitoring of your dose or condition may be needed if you are taking ketoconazole, birth control pills, or other medicine for diabetes (such as insulin, glipizide, or glyburide).

Use of this medicine is not recommended if you have newly diagnosed or worsening heart failure (acute congestive heart failure,low cost actos), type 1 diabetes, diabetic ketoacidosis, active liver disease, or experienced jaundice with troglitazone. Inform your doctor of any other medical conditions, including heart disease (e.g., chronic congestive heart failure,buy actos), allergies, pregnancy, or breast-feeding.

Use of this medicine in children under age 18 is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

Directions

Follow the directions for using this medicine provided by your doctor. This medicine may be taken on an empty stomach or with food. Store this medicine at room temperature at 77 degrees f (25 degrees c,order low cost actos) in a tightly-closed container, away from heat, moisture, and light.

If you miss a dose of this medicine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Cautions

Do not stop using this medicine or other diabetes medicine without first checking with your doctor. Check with your doctor before adjusting the dose of your diabetes medicine or changing your diet. If you are taking this medicine with other diabetes medicine, you are at an increased risk of becoming hypoglycemic (low blood sugar,discount actos). Signs of hypoglycemia include an increased heartbeat, headache, sweating, tremor, increased hunger, changes in vision, nervousness, or tiredness. Discuss with your doctor or nurse how to handle hypoglycemic reactions.

Keep all doctor and laboratory appointments while you are using this medicine. Laboratory and/or medical tests such as liver function tests and hba1c blood levels may be done to monitor your progress or to check for side effects. Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using this medicine (buy actos).

Before you begin taking any new medicine, either prescription or over-the-counter, check with your doctor or pharmacist. For women taking birth control pills: this medicine may decrease the effectiveness of your birth control pill. To prevent pregnancy, use an additional form of birth control.

For women: this medicine may increase your chance of pregnancy by causing ovulation to resume in premenopausal women who have not been ovulating. If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using this medicine during pregnancy. It is unknown if this medicine is excreted in breast milk. Do not breast-feed while taking this medicine.(buy discount actos)

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