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Avandia Consumer Information

AVANDIA

Generic Name: rosiglitazone (oral) (row sih GLIH ta zone)

Brand Names: Avandia

What is the most important information I should know about rosiglitazone?

• Usually, liver function is monitored with blood tests at the start of treatment, every two months for the first year of treatment, and periodically thereafter during treatment with rosiglitazone. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, or dark urine. These symptoms may be early signs of liver problems.
• Notify your doctor immediately if you experience an unusually rapid increase in weight or edema (water retention), shortness of breath, or chest pain during treatment with rosiglitazone. These may be early symptoms of heart problems.
• Rosiglitazone usually does not cause hypoglycemia (low blood sugar). However, hypoglycemia may occur as a result of skipped meals, excessive exercise, or alcohol consumption while taking rosiglitazone. Know the signs and symptoms of hypoglycemia, which include headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry hard candy or glucose tablets with you to treat episodes of low blood sugar.

What is rosiglitazone?

• Rosiglitazone is an antihyperglycemic agent. It helps the body respond better to insulin and it reduces the amount of sugar produced by the liver. It can help control blood sugar levels.
• Rosiglitazone is used, along with diet and exercise, in the treatment of non-insulin-dependent diabetes mellitus (type II diabetes). Rosiglitazone may also be used with a sulfonylurea (e.g., Diabeta, Glucotrol, Micronase, others), metformin (Glucophage), or insulin when diet and exercise plus any one of these medicines alone do not result in adequate blood sugar control.
• Rosiglitazone may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking rosiglitazone?

• Do not take rosiglitazone without first talking to your doctor if you have liver disease.
• Before taking this medication, tell your doctor if you
• have heart failure or heart disease;
• have edema (water retention or swelling);
• have type 1 diabetes mellitus (insulin-dependent diabetes);
• have a serious infection, illness, or injury; or
• need surgery.
• You may not be able to take rosiglitazone, or you may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• Treatment with rosiglitazone may cause resumption of fertility by allowing for the return of ovulation (production of eggs) in certain women with insulin resistance who were not ovulating before treatment with rosiglitazone. Therefore, pregnancy may occur and birth control may be a consideration.
• Rosiglitazone is in the FDA pregnancy category C. This means that it is not known whether rosiglitazone will harm an unborn baby. Generally, insulin is the drug of choice for controlling diabetes during pregnancy. Do not take rosiglitazone without first talking to your doctor if you are pregnant or could become pregnant during treatment.
• It is not known whether rosiglitazone passes into breast milk. Do not take rosiglitazone without first talking to your doctor if you are breast-feeding a baby.
• The safety and effectiveness of rosiglitazone have not been established for children.

How should I take rosiglitazone?

• Take rosiglitazone exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Rosiglitazone can be taken with or without food or meals.
• It is important to take rosiglitazone regularly to get the most benefit.
• Your doctor may want you to have blood or urine tests or other medical evaluations during treatment with rosiglitazone to monitor blood sugar levels, liver function, or other factors.
• Usually, liver function is monitored with blood tests at the start of treatment, every two months for the first year of treatment, and periodically thereafter during treatment with rosiglitazone. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, or dark urine. These symptoms may be early signs of liver problems.
• Although rosiglitazone does not usually cause hypoglycemia (low blood sugar), hypoglycemia may result from skipped meals, excessive exercise, or alcohol consumption. Know the signs and symptoms of hypoglycemia, which include headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of hard candy or glucose tablets with you to treat episodes of low blood sugar.
• Store rosiglitazone at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. If you do not remember until the next day, skip the dose you missed and take only your next regularly scheduled dose. Do not take a double dose.

What happens if I overdose?

• Seek emergency medical attention.
• Symptoms of a rosiglitazone overdose are not known.

What should I avoid while taking rosiglitazone?

• Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.
• Avoid alcohol. It lowers blood sugar and may interfere with your diabetes treatment.
• Tell your doctor and dentist that you are taking this medication before you undergo any surgery.
• Do not take any over-the-counter cough, cold, allergy, pain, or weight-loss medications without first talking to your doctor.

What are the possible side effects of rosiglitazone?

• If you experience any of the following serious side effects, stop taking rosiglitazone and seek emergency medical attention or notify your doctor immediately:
• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
• nausea, vomiting, abdominal pain, or loss of appetite;
• unusual fatigue;
• yellowing of the skin or eyes; or
• dark urine.
• Notify your doctor immediately if you experience an unusually rapid increase in weight or edema (swelling, water retention), shortness of breath, or chest pain during treatment with rosiglitazone. These may be early symptoms of heart problems.
• Although rosiglitazone does not usually cause hypoglycemia (low blood sugar), hypoglycemia may result from skipped meals, excessive exercise, or alcohol consumption. Know the signs and symptoms of hypoglycemia, which include headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of hard candy or glucose tablets with you to treat episodes of low blood sugar.
• Other less serious side effects may also occur. Continue to take rosiglitazone and talk to your doctor if you experience:
• headache; or
• sore throat, nasal discharge, or cold symptoms.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect rosiglitazone?

• No drugs have been reported to interact with rosiglitazone although interactions may exist. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

• Your pharmacist has additional information about rosiglitazone written for health professionals that you may read.
• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Limitations of This Canadian Pharmacy Information

Efforts have been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information does not endorse drugs, diagnose patients or recommend therapy. This is an educational resource only intended to supplement but not to replace the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, please check with your doctor, nurse or local pharmacist. This site does not assume any responsibility for any aspect of healthcare administered with the aid of information provided here.

Full public license and copyright information is available separately from Cerner Multum, Inc.

Version: 6.01. Revision date: 4/10/03.