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Avandaryl (Rosiglitazone Maleate / Glimepiride) - Summary

 
 



WARNING: CONGESTIVE HEART FAILURE

  • 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.

  • AVANDARYL is not recommended in patients with symptomatic heart failure. Initiation of AVANDARYL in patients with established NYHA Class III or IV heart failure is contraindicated. (See CONTRAINDICATIONS and WARNINGS, Rosiglitazone.)

 

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.


See all Avandaryl indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Avandaryl (Rosiglitazone / Glimepiride)

Adherence to a fixed-dose combination of rosiglitazone/glimepiride in subjects switching from monotherapy or dual therapy with a thiazolidinedione and/or a sulfonylurea. [2010.05]
BACKGROUND: In 2005, a fixed-dose combination therapy (FDCT) of rosiglitazone maleate and glimepiride became available for treatment of type 2 diabetes mellitus. It is hypothesized that FDCTs increase adherence by decreasing the number of required tablets. OBJECTIVE: To assess changes in medication adherence and hemoglobin A(1c) (A1C) values in subjects switching from monotherapy with either a sulfonylurea or rosiglitazone or dual therapy with both to rosiglitazone/glimepiride FDCT... CONCLUSIONS: Switching to rosiglitazone/glimepiride FDCT, in comparison with switching to dual therapy, was associated with improvements in medication adherence and glycemic control.

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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Reports of Suspected Avandaryl (Rosiglitazone / Glimepiride) Side Effects

Myocardial Infarction (95)Cardiac Failure Congestive (64)Coronary Artery Disease (44)Cerebrovascular Accident (42)Cardiac Disorder (26)Dyspnoea (17)Cardiovascular Disorder (17)Chest Pain (13)Hypertension (13)Acute Myocardial Infarction (12)more >>


Page last updated: 2010-10-05

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