Avandia Consumer Drug Information

Avandia
(Rosiglitazone)

Avandia - (Rosiglitazone)
is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. Avandia is used in the management of type 2 diabetes mellitus (also known as non-insulin-dependent diabetes mellitus (NIDDM) or adult-onset diabetes). Avandia improves glycemic control while reducing circulating insulin levels.

 

Avandia (generic name: rosiglitazone) is a 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 II diabetes. The other member in this class is pioglitazone (Actos). (Another member of this class, troglitazone or Rezulin, was removed from the market because of liver toxicity.) Patients with type II diabetes cannot make enough insulin, and the cells of their body do not respond normally to the reduced amounts of insulin that are present. (Insulin is the hormone produced by the pancreas that stimulates cells to remove glucose from the blood.) Rosiglitazone 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. At least some insulin must be produced by the pancreas in order for rosiglitazone to function. Rosiglitazone was approved by the FDA on May 28, 1999.

Important Safety Information for Avandia

Avandia, along with diet and exercise, helps improve blood sugar control. It may be prescribed alone, with metformin, a sulfonylurea, metformin plus a sulfonylurea, or insulin.

Some people may experience tiredness, weight gain or swelling with Avandia. Avandia may cause fluid retention or swelling, which could lead to or worsen heart failure, so you should tell your doctor if you have a history of these conditions. If you experience an unusually rapid increase in weight, swelling or shortness of breath while taking Avandia, talk to your doctor immediately.

In combination with insulin, Avandia may increase the risk of other heart problems. Ask your doctor about important symptoms and if the combination continues to work for you. Avandia is not for everyone. Avandia is not recommended for patients with NYHA Class 3 and 4 cardiac status or active liver disease.

If you are taking Avandia with a sulfonylurea or insulin, you may be at increased risk for low blood sugar. Ask your doctor whether you need to lower your sulfonylurea or insulin dose.

Blood tests should be used to check for liver problems before starting and while taking Avandia. Tell your doctor if you have liver disease, or if you experience unexplained tiredness, stomach problems, dark urine or yellowing of skin while taking Avandia.

If you are nursing, pregnant or thinking about becoming pregnant, talk to your doctor before taking Avandia. Avandia may increase your risk of pregnancy.

Your doctor should check your eyes regularly. Very rarely, some people have experienced vision changes due to swelling in the back of the eye while taking Avandia.

What is Avandia?
Avandia is a prescription medicine used with diet and exercise to treat type 2 (“adult-onset” or “non-insulin dependent”) diabetes mellitus (“high blood sugar”). Avandia may be used alone or with other anti-diabetic medicines. Avandia can help your body respond better to insulin made in your body. Avandia does not cause your body to make more insulin.

Before you take Avandia, you should first try to control your diabetes by diet, weight loss, and exercise. In order for Avandia to work best, it is very important to exercise, lose excess weight, and follow the diet recommended for your diabetes.

The safety and efficacy of Avandia have not been established in children under 18 years of age.

Special warnings about this medication

If you have liver disease, you should not take Avandia. Your doctor will check to make sure your liver function is normal before prescribing Avandia, then recheck it every 2 months for the first 12 months and periodically thereafter. Warning signs of liver damage include nausea, vomiting, abdominal pain, fatigue, loss of appetite, and dark urine. If you develop any of these symptoms, tell your doctor immediately. You may need to discontinue treatment with Avandia.

People taking Avandia in combination with other diabetes drugs sometimes develop low blood sugar. If this happens, check with your doctor. The dosage of the other diabetes drug may have to be reduced.

People with kidney problems can take Avandia, but should not take Glucophage. If you have poor kidney function, you'll be unable to take advantage of this combination.

Avandia can increase the chances of conception. Be sure to use some form of birth control if you don't want a pregnancy.

Avandia won't help type 1 diabetics, who are unable to produce any insulin at all. Insulin shots are a necessity for this form of the illness. Nor can Avandia relieve diabetic ketoacidosis (excessively high sugar levels due to lack of insulin).

Use Avandia with caution if you have a problem with fluid retention or swelling. The drug has been known to cause this problem, which in turn can lead to heart failure. Avandia should be avoided by anyone who has been diagnosed with heart failure, and it should be discontinued by anyone who develops it. Make sure the doctor is aware of any heart problems you may have. Alert him immediately if you develop symptoms of heart failure such as fatigue and shortness of breath.

You should be aware that people taking Avandia tend to gain a little weight, typically around 5 to 10 pounds. The cause is thought to be a combination of fluid retention and fat accumulation.

Avandia is not recommended for children under 18.
General Precautions with Avandia:

Avandia is in the same class of drugs as Rezulin, which has been associated with rare but serious liver injury, including liver failure leading to transplant or death. Because Avandia’s liver safety profile is not fully determined yet, your doctor will do blood tests that evaluate your liver before starting you on Avandia. These blood tests should be repeated every two months for the first year, then regularly after that.

Call your health care provider right away if you develop nausea, vomiting, stomach pain, a feeling of tiredness or having no energy, loss of appetite, dark urine, or jaundice (yellow coloring of eyes and skin). These may be symptoms of liver problems.

Patients who experience an unusually rapid increase in weight or retain fluid (edema) or who develop shortness of breath or other symptoms of heart failure while on Avandia should immediately report these symptoms to their health care provider.

When taking Avandia with other oral diabetes medicines, there is a risk of your blood sugar becoming dangerously low. Ask your health care provider about symptoms of low blood sugar, conditions that make low blood sugar more likely, and what to do if you get it. Make sure to explain to family members.

If you are a woman who has not reached menopause but have not had menstrual periods, you may become pregnant unless you use an effective method of birth control. Avandia, like other drugs in this class, may cause insulin resistant women to start ovulating again.

Women should tell their doctor if they notice any changes in their monthly menstrual cycle.

During periods of stress on the body, such as fever, trauma, infection, or surgery, your medication requirements may change; contact your health care provider promptly.

Managing your diabetes should include diet control. Caloric restriction, weight loss as needed, and exercise are essential for the proper treatment of diabetes because they help improve insulin sensitivity and the effectiveness of drug therapy.

Who should not take Avandia?
Do not take Avandia if you are allergic to any of the ingredients in Avandia. The active ingredient is rosiglitazone maleate. See the end of this leaflet for a list of all the ingredients in Avandia.

Before taking Avandia, tell your doctor about all your medical conditions, including if you:

have heart problems or heart failure. Avandia can cause your body to keep extra fluid (fluid retention), which leads to swelling and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure.
have type 1 (“juvenile”) diabetes or had diabetic ketoacidosis. These conditions should be treated with insulin.
have a type of diabetic eye disease called macular edema (swelling of the back of the eye).
have liver problems. Your doctor should do blood tests to check your liver before you start taking Avandia and during treatment as needed.
had liver problems while taking REZULIN® (troglitazone), another medicine for diabetes.
are pregnant or trying to become pregnant. It is not known if Avandia can harm your unborn baby. You and your doctor should talk about the best way to control your high blood sugar during pregnancy.
are a premenopausal woman (before the “change of life”) who does not have regular monthly periods. Avandia may increase your chances of becoming pregnant. Talk to your doctor about birth control choices while taking Avandia.
are breastfeeding. It is not known if Avandia passes into breast milk. You should not use Avandia while breastfeeding.
are taking prescription or non-prescription medicines, vitamins or herbal supplements. Avandia and certain other medicines can affect each other and lead to serious side effects including high blood sugar or low blood sugar. Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start a new medicine. They will tell you if it is okay to take Avandia with other medicines.

Special information if you are pregnant or breastfeeding

It's important to maintain normal blood sugar levels while pregnant, but the safety of Avandia during pregnancy remains unproven. Since insulin shots are known to be safe, your doctor may switch you from Avandia to insulin until the baby is born.

It is not known whether Avandia appears in breast milk. Because many drugs do find their way into breast milk, however, the safest bet is to avoid taking Avandia while nursing.

What should I tell my doctor or health care provider?

Tell you health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.

Because certain other medication may interact with Avandia, review all medications that you are taking with your health care provider, including those that you take without a prescription.

How should I take Avandia?
Take Avandia exactly as prescribed. Your doctor will tell you how many tablets to take and how often. The usual daily starting dose is 4 mg a day taken once a day or 2 mg taken twice a day. Your doctor may need to adjust your dose until your blood sugar is better controlled.

Avandia may be prescribed alone or with other anti-diabetic medicines. This will depend on how well your blood sugar is controlled.

Take Avandia with or without food.
It can take 2 weeks for Avandia to start lowering blood sugar. It may take 2 to 3 months to see the full effect on your blood sugar level.

If you miss a dose of Avandia, take your pill as soon as you remember, unless it is time to take your next dose. Take your next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you take too much Avandia, call your doctor or poison control center right away.

Test your blood sugar regularly as your doctor tells you.
Diet and exercise can help your body use its blood sugar better. It is important to stay on your recommended diet, lose excess weight, and get regular exercise while taking Avandia.
Your doctor should do blood tests to check your liver before you start Avandia and during treatment as needed. Your doctor should also do regular blood sugar tests (for example, “A1C”) to monitor your response to Avandia.

Your doctor should check your eyes regularly. Very rarely, some patients have experienced vision changes due to swelling in the back of the eye while taking Avandia.

 

Recommended dosage

The usual starting dose of Avandia either alone or in combination with another diabetes drug is 4 milligrams once a day or 2 milligrams twice a day. If your sugar levels remain too high after 12 weeks of treatment, the doctor may increase your dose to 8 milligrams once a day or 4 milligrams twice a day. However, the maximum recommended dose of Avandia in combination with insulin or a sulfonylurea diabetes drug is 4 milligrams per day.

 

PATIENT INFORMATION
Patients should be informed of the following: Management of type 2 diabetes should include diet control. Caloric restriction, weight loss, and exercise are essential for the proper treatment of the diabetic patient because they help improve insulin sensitivity. This is important not only in the primary treatment of type 2 diabetes, but in maintaining the efficacy of drug therapy.

It is important to adhere to dietary instructions and to regularly have blood glucose and

glycosylated hemoglobin tested. Patients should be advised that it can take 2 weeks to see a reduction in blood glucose and 2 to 3 months to see full effect. Patients should be informed that blood will be drawn to check their liver function prior to the start of therapy and periodically thereafter per the clinical judgement of the healthcare professional. Patients with unexplained symptoms of nausea, vomiting, abdominal pain, fatigue, anorexia, or dark urine should immediately report these symptoms to their physician. Patients who experience an unusually rapid increase in weight or edema or who develop shortness of breath or other symptoms of heart failure while on AVANDIA should immediately report these symptoms to their physician.

AVANDIA can be taken with or without meals.

When using AVANDIA in combination with other hypoglycemic agents, the risk of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and their family members.

Therapy with AVANDIA, like other thiazolidinediones, may result in ovulation in some premenopausal anovulatory women. As a result, these patients may be at an increased risk for pregnancy while taking AVANDIA (see PRECAUTIONS, Pregnancy, Pregnancy Category C). Thus, adequate contraception in premenopausal women should be recommended. This possible effect has not been specifically investigated in clinical studies so the frequency of this occurrence is not known.

What are possible side effects of Avandia?
heart failure. Avandia can cause your body to keep extra fluid (fluid retention), which leads to swelling and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure.

swelling (edema) from fluid retention. Call your doctor right away if you have symptoms such as:swelling or fluid retention, especially in the ankles or legs

shortness of breath or trouble breathing, especially when you lie down an unusually fast increase in weight unusual tiredness low blood sugar (hypoglycemia). Lightheadedness, dizziness, shakiness or hunger may mean that your blood sugar is too low. This can happen if you skip meals, if you use another medicine that lowers blood sugar, or if you have certain medical problems. Call your doctor if low blood sugar levels are a problem for you.

weight gain. Avandia can cause weight gain that may be due to fluid retention or extra body fat. Weight gain can be a serious problem for people with certain conditions including heart problems. Call your doctor if you have an unusually fast increase in weight.

low red blood cell count (anemia).
ovulation (release of egg from an ovary in a woman) leading to pregnancy. Ovulation may happen in premenopausal women who do not have regular monthly periods. This can increase the chance of pregnancy.

liver problems. It is important for your liver to be working normally when you take Avandia. Your doctor should do blood tests to check your liver before you start taking Avandia and during treatment as needed.

Call your doctor right away if you have unexplained symptoms such as:

nausea or vomiting
stomach pain
unusual or unexplained tiredness
loss of appetite
dark urine
yellowing of your skin or the whites of your eyes.

The most common side effects of Avandia included cold-like symptoms, injury, and headache.

How should to store Avandia?
Store Avandia at room temperature, 59° to 86°F (15° to 30°C). Keep Avandia in the container it comes in.
Safely, throw away Avandia that is out of date or no longer needed.
Keep Avandia and all medicines out of the reach of children.

OVERDOSE
Limited data are available with regard to overdosage in humans. In clinical studies in volunteers, AVANDIA has been administered at single oral doses of up to 20 mg and was well-tolerated. In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient’s clinical status.

General Information about Avandia
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Avandia for a condition for which it was not prescribed. Do not give Avandia to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes important information about Avandia. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Avandia that is written for healthcare professionals

3 Things to Help You Get Started on Avandia
To help you be more successful in your diabetes management plan and reach the goals agreed upon by you and your doctor, here are a few things to consider:

Avandia is a pill prescribed by your doctor to help lower your blood sugar. It can be taken once or twice a day, with or without food.

Remember to keep taking Avandia, as prescribed by your doctor, even if you're feeling better and your blood sugar level has improved.

As with other medications, you may experience side effects while taking Avandia. Talk to your doctor if you have any side effects.

Be sure to read the patient information for Avandia before you start taking the medication and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have questions about Avandia, ask your doctor or pharmacist.

David's Canadian Drug Store Explains how it works

It is important to know that Avandia, unlike some type 2 diabetes medications, does not cause your body to make more insulin. It can help your body use the insulin that it already makes. Avandia can help with insulin resistance by making your body more sensitive to the insulin it makes. Avandia belongs to a class of drugs called thiazolidinediones (thigh-a-zol-a-deen-die-owns) or TZDs.

When can you expect results?
Avandia can start lowering your blood sugar in about two weeks, although it may take up to 12 weeks (3 months) for you to see the full effects. Your doctor may also add Avandia to other diabetes medications you already are taking to help lower blood sugar.

DRUG INTERACTIONS
An inhibitor of CYP2C8 (such as gemfibrozil) may increase the AUC of rosiglitazone and an inducer of CYP2C8 (such as rifampin) may decrease the AUC of rosiglitazone. Therefore, if an inhibitor or an inducer of CYP2C8 is started or stopped during treatment with rosiglitazone, changes in diabetes treatment may be needed based upon clinical response.

The benefits of Avandia:
If you're making an effort to eat the right food, exercise and take your diabetes medication, but still need some help lowering blood sugar, Avandia might be an answer.

Helps lower blood sugar
Helps maintain blood sugar control*
Since its US launch in 1999, Avandia has been used by over 4.2 million patients
Offers a personal, day-to-day diabetes management plan for users of Avandia - the I Can™ program

We will not be held responsible for misuse of prescription drugs or misinformation on this website. Please check with your health care professional for all pertinent information on prescription medications before using them.