AVANDAMET INDICATIONS
After consultation with a healthcare professional who has considered and advised the patient of the risks and benefits of rosiglitazone, AVANDAMET® is indicated as an adjunct to diet and exercise to improve glycemic control when treatment with both rosiglitazone and metformin is appropriate in adults with type 2 diabetes mellitus who either are:
- already taking rosiglitazone, or
- not already taking rosiglitazone and unable to achieve glycemic control on other diabetes medications and, in consultation with their healthcare provider, have decided not to take pioglitazone (ACTOS®) or pioglitazone-containing products (ACTOPLUS MET®, ACTOPLUS MET XR®, DUETACT®) for medical reasons.
AVANDAMET INSTRUCTIONS
Take Avandamet exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Take Avandamet with meals, especially during the first few weeks of therapy.
Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.
Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.
AVANDAMET INDICATIONS
- already taking rosiglitazone, or
- not already taking rosiglitazone and unable to achieve glycemic control on other diabetes medications and, in consultation with their healthcare provider, have decided not to take pioglitazone (ACTOS®
AVANDAMET INSTRUCTIONS
Take Avandamet exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Take Avandamet with meals, especially during the first few weeks of therapy.
Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.
Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrat
Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.
Your doctor may want you to stop taking Avandamet for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.
Ask your doctor how to adjust your dose if needed. Do not change your medication dose or schedule without your doctor's advice.
Your doctor may have you take extra vitamin B12 while you are taking Avandamet. Take only the amount of vitamin B12 that your doctor has prescribed.
Avoid drinking alcohol. It can lower your blood sugar and may increase your risk of lactic acidosis while taking this medicine.
AVANDAMET STORAGE
AVANDAMET is generally given in divided doses with meals.
All patients should start the rosiglitazone component of AVANDAMET at the lowest recommended dose. Further increases in the dose of rosiglitazone should be accompanied by careful monitoring for adverse events related to fluid retention [see BOXED WARNING and WARNINGS AND PRECAUTIONS].
If therapy with a combination tablet containing rosiglitazone and metformin is considered appropriate for a patient with type 2 diabetes mellitus, then the selection of the dose of AVANDAMET should be based on the patient's current doses of rosiglitazone and/or metformin.
To switch to AVANDAMET for patients currently treated with metformin, the usual starting dose of AVANDAMET is 4 mg rosiglitazone (total daily dose) plus the dose of metformin already being taken (see Table 1).
To switch to AVANDAMET for patients currently treated with rosiglitazone, the usual starting dose of AVANDAMET is 1,000 mg metformin (total daily dose) plus the dose of rosiglitazone already being taken (see Table 1).
When switching from combination therapy of rosiglitazone plus metformin as separate tablets, the usual starting dose of AVANDAMET is the dose of rosiglitazone and metformin already being taken.
AVANDAMET is generally given in divided doses with meals, with gradual dose escalation. This reduces gastrointestinal side effects (largely due to metformin) and permits determination of the minimum effective dose for the individual patient.
Sufficient time should be given to assess adequacy of therapeutic response. FPG should be used initially to determine the therapeutic response to AVANDAMET. If additional glycemic control is
Taking Avandamet may increase your risk of serious heart problems, such as heart attack or stroke. Therefore, Avandamet is available only to certain people with type 2 diabetes that cannot be controlled with other diabetes medications.
You should not use Avandamet if you are allergic to metformin (Glucophage) or rosiglitazone (Avandia), or if you advanced heart failure, kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking Avandamet.
Before taking Avandamet, tell your doctor if you have congestive heart failure or heart disease, a history of heart attack or stroke, liver disease, or eye problems caused by diabetes.
Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.
FDA pregnancy category C. It is not known whether Avandamet will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
Avandamet may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or irregular heart rate, dizziness, or feeling very weak or tired.
Get emergency medical help if you have any of these signs of an allergic reaction to Avandamet: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any other serious side effects, such as:
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden numbness, weakness, headache, confusion, or problems with vision, speech, or balance;
- swelling or rapid weight gain, feeling short of breath, (even with mild exertion);
- pale skin, feeling light-headed, rapid heart rate, trouble concentrating, fever, confusion or weakness;
- severe blistering, peeling, and red skin rash; or
- jaundice (yellowing of the skin or eyes).
Less serious Avandamet side effects may include:
- headache, tired feeling;
- nausea, vomiting, upset stomach, diarrhea; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.