Avandamet is a medication used to treat type 2 diabetes. It is a combination of two drugs, metformin and rosiglitazone. This medication is used when diet and exercise have not been enough to control blood sugar levels. Avandamet may also be used for purposes not listed in this medication guide. You should not use Avandamet if you are allergic to metformin or rosiglitazone. To make sure Avandamet is safe for you, tell your doctor if you have ever had:

kidney disease (or if you are on dialysis);

heart disease, congestive heart failure;

a history of heart attack or stroke;

pancreatitis;

alcoholism; or

liver disease.

Some people taking Avandamet have developed a serious condition called lactic acidosis. This may be more likely to occur if you have liver or kidney disease, congestive heart failure, surgery, a heart attack or stroke, a severe infection, if you are 65 or older, if you are dehydrated, or if you drink a lot of alcohol. Talk with your doctor about your risk.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Avandamet is usually taken two times per day with meals. Follow your doctor’s instructions.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor’s office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. Your blood sugar level can drop quickly if you skip a meal, exercise too long, drink alcohol, or are under stress.

To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check your blood sugar level often, and watch for signs of low blood sugar. Ask your doctor how to adjust your Avandamet dose if needed.

Avandamet is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Store at room temperature away from moisture and heat. You may need to keep a log of your blood sugar levels for your doctor.

Avandamet dosing information

Usual Adult Dose for Diabetes Type 2:

2 mg/1000 mg orally 2 times a day with meals

Maximum dose: 4 mg/2000 mg per day

Comments: -Rosiglitazone must be taken with food. -This drug should not be used in combination with pioglitazone.

Use: Treatment of type 2 diabetes mellitus, as an adjunct to diet and exercise, when response to both is inadequate.

Benefits

Avandamet can help to control blood sugar in people with type 2 diabetes. It can also help to prevent heart attacks and strokes. Avandamet may also be used for purposes not listed in this medication guide.

Side effects

Avandamet can cause low blood sugar levels. Symptoms of low blood sugar include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. If you have any of these symptoms, eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Then check it again after 15 minutes. If it is still low, eat or drink another quick.

Pharmacokinetics

The pharmacokinetics of rosiglitazone and metformin are not affected by multiple doses of either compound. Therefore, the steady state concentrations of rosiglitazone and metformin in plasma after multiple doses are similar to those seen after a single dose. Rosiglitazone is rapidly absorbed from the gastrointestinal tract with peak plasma levels occurring between 1 and 4 hours after oral administration. The bioavailability of rosiglitazone is nearly complete (greater than 90%). Metformin hydrochloride is rapidly absorbed following oral administration, with peak plasma concentrations occurring at approximately 2 hours. Bioavailability is not related to dose but rather to gastrointestinal tolerability (i.e., nausea). Peak plasma concentrations of metformin following therapeutic doses are generally less than 1 μg/mL.

The oral plasma clearance of rosiglitazone is approximately 10 L/hr with a mean apparent volume of distribution (V/F) of 103 L. Rosiglitazone is eliminated primarily by hepatic metabolism with approximately 90% of the dose recovered in urine as metabolites and 6% excreted unchanged. The mean terminal half-life is about 2-4 hours. Metformin’s plasma elimination half-life is approximately 4.5-8.7 hours, indicating that the elimination rate of metformin is not affected by repeated administration or by changes in renal function. Less than 10% of a metformin dose is recovered as parent compound, and there is no accumulation of metformin in plasma on repeated oral administration at steady state.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 24-month study in CD-1 mice given daily doses of rosiglitazone (25, 100, or 300 mg/kg) by gavage, increased incidences of hepatocellular adenoma (300 mg/kg/day male rats: 8/50, 16/50 and 47/50; female rats: 10/50, 17/50 and 47/50; all p<0.001 vs vehicle) were seen in a dose-related manner in male and female rats. In addition, adenoma of the harderian gland (300 mg/kg/day male rats: 18/50, 26/50 and 43/50; female rats: 23/50, 27/50 and 44/50; all p<0.001 vs vehicle) was seen in a dose-related manner in both sexes of rats. Hepatocellular adenomas associated with rosiglitazone were benign tumors. No increased incidence of any tumor was seen in mice at 25 or 100 mg/kg daily.