Avandia

[Rosiglitazone maleate]

Indications & Dosage
INDICATIONS AND USAGE

AVANDIA is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. AVANDIA is indicated as monotherapy. AVANDIA is also indicated for use in combination with a sulfonylurea, metformin, or insulin when diet, exercise, and a single agent do not result in adequate glycemic control. For patients inadequately controlled with a maximum dose of a sulfonylurea or metformin, AVANDIA should be added to, rather than substituted for, a sulfonylurea or metformin.

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 AVANDIA, secondary causes of poor glycemic control, e. g., infection, should be investigated and treated.

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DOSAGE AND ADMINISTRATION

The management of antidiabetic therapy should be individualized. AVANDIA may be administered either at a starting dose of 4 mg as a single daily dose or divided and administered in the morning and evening. For patients who respond inadequately following 8 to 12 weeks of treatment, as determined by reduction in FPG, the dose may be increased to 8 mg daily as monotherapy or in combination with metformin. Reductions in glycemic parameters by dose and regimen are described under CLINICAL STUDIES. AVANDIA may be taken with or without food.

Monotherapy:

The usual starting dose of AVANDIA is 4 mg administered either as a single dose once daily or in divided doses twice daily. In clinical trials, the 4 mg twice daily regimen resulted in the greatest reduction in FPG and HbA1c.
Combination Therapy: When AVANDIA is added to existing therapy, the current dose of a sulfonylurea, metformin, or insulin can be continued upon initiation of AVANDIA therapy.

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