WARNING: CONGESTIVE HEART FAILURE
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Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients (see WARNINGS, Rosiglitazone). After initiation of AVANDARYL, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of AVANDARYL must be considered.
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AVANDARYL SUMMARY
AVANDARYL®
(rosiglitazone maleate and glimepiride)
Tablets
AVANDARYL (rosiglitazone maleate and glimepiride) tablets contain 2 oral antidiabetic drugs used in the management of type 2 diabetes: Rosiglitazone maleate and glimepiride. Rosiglitazone maleate is an oral antidiabetic agent of the thiazolidinedione class which acts primarily by increasing insulin sensitivity.
AVANDARYL is indicated as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus when treatment with dual rosiglitazone and glimepiride therapy is appropriate.
Management of type 2 diabetes should include diet control. Caloric restriction, weight loss, and exercise are essential for the proper treatment of the diabetic patient because they help improve insulin sensitivity. This is important not only in the primary treatment of type 2 diabetes, but also in maintaining the efficacy of drug therapy. Prior to initiation of therapy with AVANDARYL, secondary causes of poor glycemic control, e.g., infection, should be investigated and treated.
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NEWS HIGHLIGHTS
Published Studies Related to Avandaryl (Rosiglitazone / Glimepiride)
Initial treatment with fixed-dose combination rosiglitazone/glimepiride in patients with previously untreated type 2 diabetes. [2008.08]
AIM: This study assessed the efficacy and safety of two different dosing regimens of fixed-dose combination (FDC) rosiglitazone (RSG) plus glimepiride (GLIM) compared with RSG or GLIM monotherapy in drug-naive subjects with type 2 diabetes mellitus (T2DM)... CONCLUSIONS: Compared with RSG or GLIM monotherapy, the RSG/GLIM FDC improved glycaemic control with no significant increased risk of hypoglycaemia. RSG/GLIM FDC provides an effective and well-tolerated treatment option for drug-naive individuals with T2DM.
Initial treatment with fixed-dose combination rosiglitazone/glimepiride in patients with previously untreated type 2 diabetes. [2007.07.21]
Aim: This study assessed the efficacy and safety of two different dosing regimens of fixed-dose combination (FDC) rosiglitazone (RSG) plus glimepiride (GLIM) compared with RSG or GLIM monotherapy in drug-naive subjects with type 2 diabetes mellitus (T2DM)... RSG/GLIM FDC provides an effective and well-tolerated treatment option for drug-naive individuals with T2DM.
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Page last updated: 2008-11-02
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