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Avandamet

rosiglitazone - metformin

By SB Pharmco

What side effects are possible with this medication?

A side effect is an unwanted response to a medication when it is taken in normal doses. It can be mild or severe, temporary or permanent, but does not occur in everyone. The following side effects have been reported by at least 1% of people taking this medication. If you develop any of these side effects (or any other side effects not listed here) or they change in intensity, speak to your doctor or pharmacist for advice on managing them and on the risks and benefits of the medication.

  • anemia (low red blood cell levels)
  • back pain
  • diarrhea
  • dizziness or lightheadedness
  • fatigue
  • headache
  • joint pain
  • loss of appetite
  • low blood glucose
  • metallic taste in mouth
  • muscle soreness
  • passing gas
  • runny or stuffy nose
  • sore throat
  • swelling of feet or lower legs
  • unusual tiredness or weakness
  • upper respiratory tract infection
  • vomiting
  • weight loss
Click here to learn about serious side effects that can potentially occur with any medication. These examples are provided for information purposes only and are not meant to be exhaustive. Always consult your doctor for sound medical advice specific to your particular medication and treatment.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online or by phone at 1-800-332-1088.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Anemia: This medication may cause anemia (low red blood cell counts). This is more likely to occur during the first few months of therapy with this medication, or after an increase in dose. Your doctor may run some tests to monitor your red blood cell levels.

Blood glucose control: For people who take rosiglitazone - metformin, loss of blood glucose control may occur during illness or stressful situations such as trauma or surgery. Under these conditions, your doctor may consider stopping the medication and prescribing insulin until the situation improves.

Diet and exercise: Treatment with rosiglitazone - metformin must take place in addition to a proper diet and exercise program and not be used as a substitute for an appropriate diet and exercise program.

Edema: If you have edema, or swelling of the feet or lower legs, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Fractures: Women taking rosiglitazone may be at an increased risk of bone fractures of the upper arm, hand, and foot. Discuss the risks and benefits of using this medication with your doctor.

Heart attack or stroke: There is some evidence that people taking rosiglitazone may be at increased risk of heart attack or stroke. However, more studies are needed to confirm this risk. Talk to your doctor about the risks and benefits of taking this medication. If you experience chest pain or pressure in the chest, seek immediate medical attention.

Heart failure: Rosiglitazone can cause fluid buildup in the body, which may lead to congestive heart failure or make existing congestive heart failure worse. This medication should not be used by anyone who has severe heart failure (see section, "Who should not take this medication?").

Due to the risk of worsening heart failure, rosiglitazone is not recommended for people with heart failure symptoms. If you develop fluid buildup or swelling, shortness of breath, fatigue, or excessive weight gain while taking this medication, contact your doctor immediately.

There is some evidence that people with less severe heart failure (NYHA Class I and II) may be at an increased risk of heart-related problems such as angina and heart attack while taking rosiglitazone.

If you have heart failure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney disease: People who have kidney disease or impaired kidney function may require a lower dose of this medication as prescribed by the doctor. If you have kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Lactic acidosis: Lactic acidosis is a rare but serious problem that occurs due to metformin accumulation (i.e., the body does not get rid of it fast enough) during treatment with metformin. People with severe kidney disease, heart failure, or dehydration are at higher risk of developing lactic acidosis. Excessive alcohol intake can also increase the risk of lactic acidosis. When it does occur (very rarely), it is fatal in about 50% of cases.

If you have kidney or liver disease you should especially be monitored closely by your doctor while taking rosiglitazone - metformin. If you experience symptoms of lactic acidosis (e.g., weakness; tiredness; drowsiness; unusual muscle pain; trouble breathing; stomach pain with nausea, vomiting, or diarrhea; feeling cold; dizziness; lightheadedness; slow or irregular heartbeat), stop taking this medication and get immediate medical attention.

Liver: Your doctor will likely order liver tests to monitor your liver function before and during treatment. You should report any signs of liver problems to your doctor immediately while taking this medication. These signs include:

  • abdominal or stomach pain
  • dark urine
  • loss of appetite
  • nausea or vomiting
  • unusual tiredness or weakness
  • yellow eyes or skin

Low blood glucose: This medication may cause low blood glucose (hypoglycemia). Situations which may bring this on include:

  • advanced age
  • alcoholism
  • certain thyroid diseases
  • exercise without adequate calorie intake
  • liver disease or kidney disease
  • malnutrition or irregular meals

Signs of low blood glucose include:

  • dizziness
  • drowsiness
  • headache
  • lack of energy
  • nervousness
  • numbness or tingling
  • shakiness
  • sweating
  • weakness

Monitor your blood glucose regularly and keep emergency glucose (and a glucagon kit) available in case you need to increase blood sugar levels. Talk with your doctor or diabetes educator about this.

Macular edema: There have been some reports of macular edema (swelling of the retina in the eye) with use of this medication. If you have diabetes you should have regular eye exams by an ophthalmologist. If you notice any visual changes, contact your doctor immediately.

Ovulation: Some women using rosiglitazone may start having menstrual periods, even after not having a period due to a medical condition. As a result, you may be at increased risks for pregnancy while taking rosiglitazone. Adequate contraception (birth control) is recommended if you are premenopausal.

Radiologic studies involving intravascular iodinated contrast media: Inform your doctor that you are on this medication if you need to have any type of X-ray or CT scan using a dye that is injected into your veins. This medication should be temporarily stopped prior to the procedure.

Surgery: This medication should be stopped 2 days before any surgical procedure (except minor procedures with no restrictions on food or fluid intake).

Vitamin B12: Some people may not be able to absorb enough vitamin B12 while they are taking this medication. Some people using this medication should have their levels of vitamin B12 checked routinely.

Weight gain: There is some evidence that rosiglitazone may cause unusually fast increases in weight. If you experience significant changes in weight, contact your doctor immediately.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately. Usually, insulin is used to control high blood sugar during pregnancy.

Breast-feeding: It is not known if this medication passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for children.

Seniors: Seniors may be more sensitive to the effects of this medication. They may need a lower dose.

What other drugs could interact with this medication?

There may be an interaction between rosiglitazone - metformin and any of the following:

  • alcohol
  • birth control pills
  • calcium channel blockers (e.g., diltiazem, verapamil)
  • cationic medications (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin)
  • cimetidine
  • corticosteroids (e.g., prednisone, hydrocortisone)
  • furosemide
  • gemfibrozil
  • isoniazid
  • nicotinic acid
  • nifedipine
  • phenothiazines (e.g., chlorpromazine)
  • rifampin
  • sympathomimetic medications (e.g., pseudoephedrine, phenylpropanolamine, epineprine)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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© 1996 - 2011 MediResource Inc. The contents of this health site are for informational purposes only. Always seek the advice of your physician or other qualified healthcare provider regarding any questions you may have about a medical condition.