Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Endocrinology | Family Medicine
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Avandamet (rosiglitazone maleate and metformin HCl)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved October 2002
Treatment Area: Type 2 Diabetes
Avandamet (rosiglitazone maleate and metformin HCl) has been
approved as an adjunct to diet and exercise to improve blood sugar
control in type 2 diabetes patients who are already treated with
combination rosiglitazone and metformin or who are not adequately
controlled on metformin alone.
Avandamet, available in oral tablet formulation, is the first
treatment to combine this combination of drugs in one pill.
Clinical studies have been conducted with the combination of
rosiglitazone maleate and metformin HCl, as well as with each
component alone. These studies have shown that the products are
safe and effective in controlling blood sugar levels in type 2
No efficacy studies have been conducted for Avandamet tablets.
However, Avandamet has been shown to be bioequivalent to
co-administered rosiglitazone maleate tablets and metformin
In clinical trials of rosiglitazone maleate in combination with
metformin hydrochloride 2500 mg/day, the following adverse events
were reported most frequently:
- Upper respiratory tract infection
- Back pain
- Viral infection
A small number of people who have been treated with metformin
have developed the serious yet rare condition called lactic
acidosis (a build up of lactic acid in the blood). Most often,
lactic acidosis occurs in people with kidney problems, and it can
Rosiglitazone may cause fluid retention, especially if it is
used with insulin. Untreated fluid retention could lead to or
worsen heart failure.
Avandamet should not be used with insulin, and should not be
used by patients with kidney disease, congestive heart failure, or
Mechanism of Action
Rosiglitazone maleate is a member of the thiazolidinedione class
of antidiabetic agents and is a PPARgamma agonist. It improves
glycemic control by improving insulin sensitivity while reducing
circulating insulin levels.
Metformin hydrochloride is a member of the biguanide class of
antidiabetic agents. It decreases hepatic glucose production,
decreases intestinal absorption of glucose, and increases
peripheral glucose uptake and utilization. Unlike sulfonylureas,
metformin does not produce hypoglycemia in either patients with
type 2 diabetes or normal subjects and does not cause
hyperinsulinemia. With metformin therapy, insulin secretion remains
unchanged, while fasting insulin levels and day-long plasma insulin
response may actually decrease. (from FDA prescription label)
For more information about Avandamet, please visit the
GlaxoSmithKline web site at www.gsk.com.