Avandia

Avandia Medication Information:

Avandia medication comes in several different strengths; click on the strength you need to view prices from pharmacies competing to earn your business.

Avandia 2 mg
Avandia 4 mg
Avandia 8 mg

Avandia General Information:

Rosiglitazone, or more commonly called Avandia, is a prescription drug manufactured by GlaxoSmithKline to help treat type 2 diabetes. Type 2 diabetes is non-insulin dependent, adult onset type of diabetes that causes a person's blood glucose level to get too high. Avandia is not intended to treat type 1 diabetes and should only be used under the care of a physician. Avandia received FDA approval in 1999 and millions of Americans are currently taking this medication.

How does Avandia work and what does it do?

Avandia is an oral drug that is used to treat diabetes mellitus. Typically it is prescribed only when natural methods like diet, exercise, and weight loss have not effectively lowered blood glucose levels. Your body naturally produces glucose, which is a sugar that the body uses for energy. However, a person who suffers from type 2 diabetes is unable to move the glucose from their bloodstream into their cells. This is where Avandia comes into play. It works to with the insulin that your body already produces to help move the glucose out of the bloodstream and into the body's cells where it can be used for energy.

How and when should Avandia be used?

Avandia is taken orally, with or without food, once or twice a day. Usually a person will take this medication once in the morning and again in the evening. Patients should start out taking 4 mg in one single dose or divided into two daily doses. A person should not take more than two doses or 8 mg in any one day. Dosages can be either increased or decreased as needed under the care of a physician and you should always take Avandia as prescribed by your doctor and you should not take extra doses or skip doses.

Side Effects

As with any prescription drug, there are side effects related to Avandia. They include:

  • Headache
  • Weight gain
  • Blurred vision or other vision impairment
  • Stomach pain, nausea, and/or vomiting
  • Fatigue, tiredness, or weakness
  • An allergic reaction that can result in hives, itching, and/or a rash
  • Difficulty breathing
  • Symptoms of heart problems such as tightness in the chest or shortness of breath
  • Swelling of the hands, legs, ankles or face
  • Dark colored urine or yellowing of the skin which can be an indication of liver damage
  • Unusual bone pain or back pain
  • Anemia
  • Upper respiratory infections
  • Mild diarrhea
  • Women who have stopped menstruating may start to have periods again which can result in pregnancy

Many people can take this medication with absolutely no adverse reactions to it and those that do have a reaction, it is usually very minor. However, if you experience any of these symptoms you need to contact your doctor immediately.

Other Brand Names for Avandia:

Rosiglitazone -- Generic name
Avandamet
Avandaryl

Safety Information:

Avandia is recommended for men and women who have type 2 diabetes but there are certain people who should not take Avandia. This includes any person who:

  • is pregnant or is planning to become pregnant
  • is breastfeeding
  • is currently taking insulin or nitrates
  • has had heart problems or is at a high risk for heart problems
  • is taking medications to treat high cholesterol, stroke, or high blood pressure
  • has or is suffering from eye problems related to diabetes
  • has type 1 diabetes
  • is in a state of diabetic ketoacidosis
  • is under the age of 18

As with any prescription medication, it is important to talk to your doctor about your medical history to determine if this drug is right for you and always take it as prescribed.

Dosage:

  • Pill - 2 mg
  • Pill - 4 mg
  • Pill - 8 mg

Visual Description:

Avandia is a pinkish, film coated, pentagonal shaped pill. These pills come packaged in a bottle of 30, 60, 90, or 180.

About Avandia

What Avandia is used for

Your doctor has prescribed AVANDIA (ah-VAN-dee-a) in addition to diet and exercise to treat your type 2 (non-insulin-dependent) diabetes in order to reduce insulin resistance and to improve your blood sugar control.

AVANDIA is used:

  • alone in patients who cannot take metformin, or

  • in combination with metformin, or

  • in combination with a sulfonylurea in patients who cannot take metformin.

In order for AVANDIA to be effective, you should continue to exercise and follow the diet recommended for your diabetes while taking AVANDIA.

People who have diabetes have problems with insulin. Insulin is produced by an organ called the pancreas (PAN-kree-us). Inside the pancreas are special cells called beta-cells that actually make insulin. Insulin is a hormone (body's own natural chemical) that allows the body's tissues to absorb glucose (known as “sugar”) from the bloodstream to provide the body energy.

People with Type 2 diabetes do not make enough insulin, or the body tissues become less sensitive to insulin. When the tissues do not respond normally to insulin, it is as if they cannot “hear” the signals insulin sends out—this is called “insulin resistance.”

With diabetes, sugar (glucose) builds up in the blood. This can lead to serious medical problems including kidney damage, heart disease, loss of limbs, and blindness. The main goal of treating diabetes is to lower your blood sugar to a normal level. Lowering and controlling blood sugar may help prevent or delay complications of diabetes such as heart disease, kidney disease or blindness.

What Avandia does

AVANDIA helps your body use its own insulin better by making the tissues more sensitive to insulin. The tissues are better able to “hear” the signals insulin sends out. That means the tissues will absorb sugar more easily. This in turn, keeps the amount of sugar in your blood at a more normal level.

When Avandia should not be used

  • If you have or have had heart problems or heart failure (the heart cannot pump enough blood to the body’s other organs), talk to your doctor. AVANDIA can cause your body to keep extra fluid (fluid retention), which can make some heart problems worse lead to heart failure, swelling and weight gain.

  • If you are allergic to AVANDIA or any of its components.

  • If you have serious liver problems.

  • If you are pregnant.

What the medicinal ingredient is

AVANDIA tablets contain the active ingredient rosiglitazone maleate.

What the nonmedicinal ingredients for Avandia are

Hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3000, sodium starch glycolate, titanium dioxide, and triacetin and one or more of the following: synthetic red and yellow iron oxides, and talc.

What dosage forms Avandia comes in

2 mg, 4 mg and 8 mg tablets.


Warnings and Precautions

BEFORE you use AVANDIA talk to your doctor or pharmacist about all your medical conditions, including if:

  • you have experienced edema (swelling in the wrists, hands, feet or ankles).

  • you are taking nitrate medicines (such as nitroglycerin or isosorbide dinitrate).

  • you have a type of diabetic eye disease called macular edema (swelling in the back of the eye).

  • you have liver problems.

  • you are breast-feeding.

  • you are pregnant or planning to become pregnant.

  • you are near menopause but not ovulating (e.g., you are a patient with polycystic ovary syndrome). AVANDIA could make you ovulate again, which means you could get pregnant. Talk to your doctor about effective methods of birth control (e.g., hormonal contraceptive pills).

Broken bones, usually in the hand, upper arm or foot, have been seen in women taking AVANDIA. Talk to your doctor about the risk of fracture.

For some people taking AVANDIA, possible side effects may include heart problems other than heart failure. Talk to your doctor if you have been diagnosed with angina (chest pain), or you have potential heart-related risks, including cigarette smoking, high blood pressure, high cholesterol and a family history of heart attack.

The safety and effectiveness of AVANDIA have not been established in children under 18 years of age, therefore AVANDIA is not recommended for use in these patients.

AVANDIA is not recommended for type 1 diabetes or diabetic ketoacidosis (dangerously high levels of ketones, which signals the body doesn't have enough insulin).

AVANDIA is not approved for use with insulin therapy, therefore AVANDIA is not recommended for use with insulin.

AVANDIA is not approved for use with metformin AND a sulfonylurea, therefore AVANDIA is not recommended for use with metformin AND a sulfonylurea.


Interactions with Avandia

AVANDIA may affect how other medicines work and some medicines may affect how AVANDIA works. Drugs that may interact with AVANDIA (rosiglitazone) include: gemfibrozil (used to lower cholesterol and triglyceride levels in your blood) rifampin (used to treat tuberculosis), methrotrexate (used to treat psoriasis or rheumatoid arthritis).

Keep a list of all the medicines you take and tell your doctor and pharmacist about every medication you take. This means both prescription medications (the ones your doctor writes for you) and over-the-counter medications (the ones you buy in the drugstore, like cold or allergy medicines), or natural health products (herbal medicines).


Proper Use of Avandia

Usual dose

AVANDIA should be taken by mouth once a day (in the morning) or twice a day (in the morning and in the evening). AVANDIA is a medicine that works over time. It may take anywhere from eight to twelve weeks to see the optimal effects.

Since food doesn't affect how your body uses AVANDIA, you can take it with meals or without. To help you remember to take AVANDIA, try to take it at the same time every day.

Test your blood sugar regularly as your doctor tells you.

Remember: This medicine has been prescribed only for you. Do not give it to anybody else.

Overdose

Taking too much of any medicine can be dangerous. If you take too many AVANDIA tablets at once, call your doctor or go to the emergency room of your local hospital or contact a poison control centre immediately.

Missed dose

If you take AVANDIA once a day and miss one dose, take the dose as soon as you remember anytime during the day.

If you take AVANDIA twice a day, take the missed dose as soon as you remember. Then take the next dose at the usual time.

Never take three doses in one day to make up for a missed dose the day before.

If you miss a whole day of AVANDIA, just take your dose as usual the next day. Don't try to make it up by taking extra tablets.

Recommended clinical and laboratory tests while taking AVANDIA

Your doctor may do additional blood sugar tests to see how well AVANDIA is working.

Your doctor may also recommend a blood test to monitor your liver before you start AVANDIA and repeat the test periodically while you are on AVANDIA.

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


Side Effects for Avandia and What to Do About Them

Common side effects (could affect up to one in 10 people):

  • Anemia (low red blood cell count) which may make you feel very weak or tired.

  • Edema (fluid retention or swelling) which could lead to or worsen heart failure. If you notice swelling in your extremities (arms and legs, hands and feet), an unusually rapid increase in weight, or if you experience unusual tiredness, trouble breathing or shortness of breath, call your doctor. These symptoms, although not specific, may signal heart problems or heart failure. Pay closer attention to these symptoms if you are using the higher dose of AVANDIA 8 mg by itself or AVANDIA 4 mg in combination with a sulfonylurea as fluid retention is more common.

  • Broken bones usually in the hand, upper arm or foot in women. Talk to your doctor about the risk of fracture.

  • A small increase in total cholesterol levels. Total cholesterol is made up of “good cholesterol” (HDLc) and “bad cholesterol” (LDLc) and it is the balance of these that is more important than the total level. AVANDIA does not affect the balance of good and bad cholesterol. If you have any concerns about your cholesterol levels, you should speak to your doctor.

  • Low blood sugar (hypoglycemia) if you are taking AVANDIA in combination with another diabetes medicine (e.g., metformin or a sulfonylurea). Dizziness, lack of energy, drowsiness, headache, trembling, sweating, or hunger may mean that your blood sugar is too low. This can happen if you skip meals, drink alcohol, use another medicine that lowers blood sugar, exercise (particularly hard or long), or if you have certain medical problems. Call your doctor if you feel that your symptoms of low blood sugar are uncomfortable. If you are using AVANDIA by itself, the risk of low blood sugar is low.

  • Increased weight. Tell your doctor if you gain a lot of weight in a short period of time.

Uncommon side effects (could affect up to one in 100 people):

  • Heart failure or pulmonary edema (fluid accumulation in the lungs) when AVANDIA is taken in combination with a sulfonylurea. Symptoms of heart failure include shortness of breath, getting tired easily after light physical activity such as walking, unusual tiredness, waking up short of breath at night, swollen ankles or feet, and an unusually rapid increase in weight. Symptoms of fluid in the lungs are breathlessness, which may be very severe and usually worsens on lying down. Stop taking AVANDIA and call your doctor right away if you experience these symptoms.

  • Constipation.

  • Increased hunger.

Rare side effects (could affect up to one in 1000 people):

  • Heart failure or pulmonary edema (fluid accumulation in the lungs), when AVANDIA is taken alone or in combination with metformin. Symptoms of heart failure include shortness of breath, getting tired easily after light physical activity such as walking, unusual tiredness, waking up short of breath at night, swollen ankles or feet, and an unusually rapid increase in weight. Symptoms of fluid in the lungs are breathlessness, which may be very severe and usually worsens on lying down. Stop taking AVANDIA and call your doctor right away if you experience these symptoms.

  • Liver problems. If you experience nausea, vomiting, stomach pain, lack of appetite, tiredness, dark urine, or yellowing of the skin, stop taking AVANDIA and call your doctor right away.

  • Blurred vision due to swelling (or fluid) in the back of the eye.

Very rare side effects (could affect up to one in 10 000 people):

  • Allergic reactions, which may include hives or rash (which may be itchy), or more serious symptoms which may occur suddenly, such as swelling of the face, lips, mouth, tongue or throat (which may cause difficulty in swallowing or breathing). Stop taking AVANDIA and call your doctor right away if you experience these symptoms.

  • Breakthrough bleeding (unexpected vaginal bleeding or spotting) while using oral contraceptives, or generally, if you experience any symptoms that persist or become troublesome, these should be discussed with your doctor.

You may experience swelling of the parotid gland (salivary glands located over the jaw, in front of the ears).

Serious Side Effects, How Often They Happen and What to Do About Them
Symptom/Effect Talk with your doctor or pharmacist Stop taking drug and call your doctor immediately
Only if severe In all cases
Common Low red blood cell count (anemia): feeling very weak or tired    
Fluid retention or swelling in extremities (arms and legs, hands and feet)    
Common (when AVANDIA is taken with other antidiabetic medicines) Low blood sugar levels (hypoglycemia): Dizziness, lack of energy, drowsiness, headache, trembling sweating, or hunger    
Uncommon (when AVANDIA is taken in combination with a sulfonylurea) Heart failure or fluid in the lungs (pulmonary edema): trouble breathing or shortness of breath, getting tired easily after light physical activity, unusual tiredness, waking up short of breath at night, swollen ankles or feet, an unusually rapid increase in weight    
Rare (when AVANDIA is taken alone or in combination with metformin) Heart failure or fluid in the lungs (pulmonary edema): trouble breathing or shortness of breath, getting tired easily after light physical activity, unusual tiredness, waking up short of breath at night, swollen ankles or feet, an unusually rapid increase in weight    
Rare Liver problems: nausea, vomiting, stomach pain, lack of appetite, tiredness, dark urine, or yellowing of the skin    
Blurred vision or decreased vision [which may be due to swelling (or fluid) in the back of the eye]    
Very rare Allergic reactions: hives or rash (which may be itchy), or more serious symptoms which may occur suddenly, such as swelling of the face, lips, mouth, tongue or throat (may cause difficulty in swallowing or breathing)    

This is not a complete list of side effects. If you experience any unexpected effects while taking AVANDIA, contact your doctor or pharmacist.


Avandia Facts

The drug Avandia is manufactured and distributed by GlaxoSmithKline.

In clinical trials for Avandia, around 9,900 patients with type 2 diabetes were evaluated.

In one clinical trial, Avandia treatment was evaluated for a span of four to six years.

Avandia obtained its first approval from the FDA on May 25, 1999.

 

Technical Information