Avandia (Rosiglitazone) Dosage and Side Effects
AVANDIA is used in addition to diet and exercise to lower blood sugar in patients with type 2 diabetes (non-insulin dependent) when all other diabetes medicines taken orally (by mouth) have not lowered blood sugar enough or are not appropriate.
Warnings and Precautions
AVANDIA may increase the risk of serious heart problems, including:
- heart failure
- angina (chest pain)
- heart attack (myocardial infarction)
- fluid retention (with or without rapid weight gain).
AVANDIA should not be used if you have or have had heart problems.
Before you use AVANDIA, talk to your doctor about other options to treat your diabetes.
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 have been diagnosed with angina (chest pain) or have had a heart attack.
- you have heart-related risks, including cigarette smoking, high blood pressure, high cholesterol, or a family history of heart attack.
- 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 not 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 people taking AVANDIA. Talk to your doctor about the risk of fracture.
Decreases in spine and hip bone mineral density (a measure of bone strength, based on the amount of calcium and other minerals in your bones) have been reported in men and women taking rosiglitazone.
Muscle problems, including muscle tenderness, weakness, or pain that you cannot explain, have been seen in people taking AVANDIA. Talk with your doctor if you experience these symptoms. If you experience brownish or discoloured urine with your muscle problems, stop taking AVANDIA and call your doctor right away.
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.
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.
- Chest pain (angina).
- Heart failure or pulmonary edema (fluid accumulation in the lungs) when AVANDIA is taken in combination with a sulfonylurea, or 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.
- 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 people taking AVANDIA. 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 used alone. 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.
- Increased hunger.
Rare side effects (could affect up to one in 1000 people):
- 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.
- Muscle problems. If you experience muscle tenderness, weakness, or pain that you cannot explain, talk with your doctor. If you experience brownish or discoloured urine with your muscle problems, stop taking AVANDIA and call your doctor right away.
- You may experience swelling of the parotid gland (salivary glands located over the jaw, in front of the ears).
Interactions with this medication
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 this medication
The usual starting dose of AVANDIA is 4 mg per day. Your doctor will decide on the dose of AVANDIA that is suitable for you.
AVANDIA should be taken by mouth once a day (in the morning) or twice a day (in the morning and in the evening) depending on the dose your doctor has given you. 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.
Take your AVANDIA each day, as instructed by your doctor. AVANDIA can help control your blood sugar levels only if you take it regularly.
Taking too much of any medicine can be dangerous.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
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.
Other related products
The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.