Most important fact about Avandamet
Avandamet could cause a very rare--but potentially fatal--side effect known as lactic acidosis. It is caused by a buildup of lactic acid in the blood. The problem is most likely to occur in people whose liver or kidneys are not working well, and in those who have multiple medical problems, take several medications, or have congestive heart failure. The risk also is higher if you are an older adult or drink alcohol. Lactic acidosis is a medical emergency that must be treated in a hospital. Notify your doctor immediately if you experience any of the following:
• Symptoms of lactic acidosis may include:
Dizziness, extreme weakness or tiredness, light-headedness, low body temperature, slow or irregular heartbeat, rapid breathing or trouble breathing, sleepiness, unexpected or unusual stomach discomfort (especially after you have been taking Avandamet for a while), unusual muscle pain
How should you take Avandamet?
Do not take more or less of Avandamet than directed by your doctor. Avandamet should be taken in divided doses with meals to reduce the possibility of nausea or diarrhea, especially during the first few weeks of therapy. Avandamet may start to work within the first week or two after you begin taking it, but it can take up to 3 months before the drug's full effects are seen. Be sure to check your blood sugar as your doctor recommends.
--If you miss a dose...
Take the forgotten dose as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular schedule. Do not take two doses at once.
--Storage instructions...
Store at room temperature in a tight, light-resistant container.
What side effects may occur?
Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue using Avandamet.
• More common side effects may include:
Accidental injury, anemia, back pain, diarrhea, fatigue, headache, joint pain, nausea, sinus inflammation, swelling, upper respiratory infection, upset stomach, viral infection
Why should Avandamet not be prescribed?
Avandamet is processed primarily by the kidneys, and can build up to excessive levels in the body if the kidneys aren't working properly. It should be avoided if you have kidney disease or your kidney function has been impaired by a condition such as shock, blood poisoning, or a heart attack.
You should not use Avandamet if you need to take medicine for congestive heart failure.
Do not take Avandamet if you have ever had an allergic reaction to rosiglitazone or metformin.
Do not take Avandamet if you have metabolic or diabetic ketoacidosis (a life-threatening medical emergency caused by insufficient insulin and marked by excessive thirst, nausea, fatigue, pain below the breastbone, and fruity breath).
You should not use Avandamet if you have type 1 (insulin-dependent) diabetes, or if you are already taking insulin.
Special warnings about Avandamet
Use Avandamet with caution if you have a problem with fluid retention or swelling. The drug has been known to cause this problem, which in turn can lead to heart failure. Also use caution if you're at risk for heart failure. Call the doctor immediately if you develop symptoms of heart failure such as a sudden weight change, fatigue, shortness of breath, or swelling of the ankles or legs.
Before you start therapy with Avandamet, and at least once a year thereafter, your doctor will do a complete assessment of your kidney function. If you develop kidney problems while on Avandamet, your doctor will discontinue Avandamet. If you are an older person, you will need to have your kidney function monitored more frequently, and your doctor may want to start you at a lower dosage.
Poor liver function could increase the risk of lactic acidosis. Therefore, your doctor will check to make sure your liver function is normal before prescribing Avandamet, then recheck it every 2 months for the first 12 months and periodically thereafter. Warning signs of liver damage include nausea, vomiting, abdominal pain, fatigue, loss of appetite, dark urine, and yellowing of the skin or whites of the eyes. If you develop any of these symptoms, tell your doctor immediately. You may need to discontinue treatment with Avandamet.
You should not take Avandamet for 2 days before and after having an X-ray procedure (such as an angiogram) that uses an injectable dye. Also, if you are going to have surgery, except minor surgery, you should stop taking Avandamet. Once you have resumed normal food and fluid intake, your doctor will tell you when you can start drug therapy again.
Avoid drinking too much alcohol while taking Avandamet. Heavy drinking increases the danger of lactic acidosis and can also trigger an attack of low blood sugar.
Avandamet occasionally causes a mild deficiency of vitamin B12. Your doctor will check for this with yearly blood tests and may prescribe a supplement if necessary.
While taking Avandamet, you should check your blood or urine periodically for abnormal sugar levels. If you notice sudden changes after you've been stabilized for a while, tell your doctor immediately. It could be a sign you're developing lactic acidosis or ketoacidosis.
Avandamet does not usually cause hypoglycemia (low blood sugar). However, it remains a possibility, especially in older, weak, and undernourished people and those with kidney, liver, adrenal, or pituitary gland problems. The risk of low blood sugar increases when Avandamet is combined with other diabetes medications. The risk is also boosted by missed meals, alcohol, and excessive exercise. To avoid low blood sugar, you should closely follow the diet and exercise plan suggested by your doctor.
If your blood sugar becomes unstable due to the stress of a fever, injury, infection, or surgery, your doctor may temporarily take you off Avandamet and ask you to take insulin instead.
You should stop taking Avandamet if you become seriously dehydrated, since this increases the likelihood of developing lactic acidosis. Tell your doctor if you lose a significant amount of fluid due to vomiting, diarrhea, fever, or some other condition.
Avandamet could trigger ovulation in premenopausal women who have stopped ovulating. It is important for all women who do not wish to get pregnant to use adequate birth control while taking Avandamet.
Possible food and drug interactions when taking Avandamet
If Avandamet is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Avandamet with the following:
Amiloride (Moduretic)
Calcium channel blockers (heart medications) such as Calan, Isoptin, and Procardia
Cimetidine (Tagamet)
Decongestant, airway-opening drugs such as Sudafed and Ventolin
Digoxin (Lanoxin)
Estrogens such as Premarin
Furosemide (Lasix)
Isoniazid (Rifamate), a drug used for tuberculosis
Morphine
Niacin (Niaspan)
Nifedipine (Adalat, Procardia)
Oral contraceptives
Phenytoin (Dilantin)
Procainamide (Procanbid, Pronestyl)
Quinidine (Quinidex)
Quinine
Ranitidine (Zantac)
Steroids such as prednisone (Deltasone)
Thyroid hormones such as Synthroid
Tranquilizers such as Thorazine
Triamterene (Dyazide, Dyrenium)
Trimethoprim (Bactrim, Septra)
Vancomycin (Vancocin)
Water pills (diuretics) such as HydroDIURIL, Dyazide, and Moduretic
Do not drink too much alcohol, since excessive alcohol consumption can cause low blood sugar and increase the risk of developing lactic acidosis.
Special information if you are pregnant or breastfeeding
If you are pregnant or plan to become pregnant, tell your doctor immediately. Avandamet has not been adequately studied in pregnant women and should not be taken during pregnancy unless the potential benefit outweighs the potential risk. Since studies suggest the importance of maintaining normal blood sugar levels during pregnancy, your doctor may prescribe insulin injections instead.
It is not known whether Avandamet appears in human breast milk. Therefore, you should discuss with your doctor whether to discontinue the medication or to stop breastfeeding. If the medication is discontinued and if diet alone does not control blood sugar levels, your doctor may prescribe insulin injections.
Recommended dosage
ADULTS
Your doctor will start therapy at a low dose and increase it until your blood sugar levels are under control.
For patients who are inadequately controlled on metformin therapy alone
The recommended daily starting dose is 4 milligrams of rosiglitazone plus the dose of metformin you are already taking.
For patients who are inadequately controlled on rosiglitazone therapy alone
The recommended daily starting dose is 1,000 milligrams of metformin plus the dose of rosiglitazone you are already taking.
For patients on combination therapy taking separate doses of rosiglitazone and metformin
The usual starting dose of Avandamet is based on your current doses of rosiglitazone and metformin.
For patients who need to increase their current dose of Avandamet
The daily dose of Avandamet may be increased by increments of 4 milligrams of rosiglitazone and/or 500 milligrams of metformin, up to a maximum daily dose of 8 milligrams of rosiglitazone and 2,000 milligrams of metformin.
CHILDREN
Children should not take Avandamet, since the safety and effectiveness of the drug have not been studied in this group.
Overdosage
An overdose of Avandamet can cause lactic acidosis (see "Most important fact about Avandamet"). If you suspect an overdose, seek emergency treatment immediately.