Combination Diabetes Treatment Approved by FDA
As with metformin, the contraindications to therapy with the combination product are renal disease or dysfunction, congestive heart failure requiring pharmacotherapy, and metabolic acidosis. A box in the labeling warns about the possibility of lactic acidosis developing in patients during metformin therapy.
The labeling contains instructions on starting combination therapy in patients already receiving one but not both drugs and the explicit direction not to use the product as initial treatment.
Avandamet will be available in tablets containing 1, 2, or 4 mg of rosiglitazone and 500 mg of metformin in 60- and 100-count bottles and unit dose packages.
Rosiglitazone is marketed solely by GlaxoSmithKline under the brand name Avandia. Metformin is available from several companies.