Avandamet

[rosiglitazone maleate and metformin HCl]

Indications & Dosage
INDICATIONS AND USAGE

AVANDAMET is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus who are already treated with combination rosiglitazone and metformin or who are not adequately controlled on metformin alone.

Management of type 2 diabetes mellitus 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 or escalation of oral antidiabetic therapy in patients with type 2 diabetes mellitus, secondary causes of poor glycemic control, e. g., infection, should be investigated and treated. The safety and efficacy of AVANDAMET as initial pharmacologic therapy for patients with type 2 diabetes mellitus after a trial of caloric restriction, weight loss, and exercise has not been established.

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DOSAGE AND ADMINISTRATION

General

The selection of the dose of AVANDAMET should be based on the patient's current doses of rosiglitazone and/ or metformin. The safety and efficacy of AVANDAMET as initial therapy for patients with type 2 diabetes mellitus have not been established. The following recommendations regarding the use of AVANDAMET in patients inadequately controlled on rosiglitazone and metformin monotherapies are based on clinical practice experience with rosiglitazone and metformin combination therapy.

The dosage of antidiabetic therapy with AVANDAMET should be individualized on the basis of effectiveness and tolerability while not exceeding the maximum recommended daily dose of 8 mg/ 2,000 mg. AVANDAMET should be given in divided doses with meals, with gradual dose escalation. This reduces GI side effects (largely due to metformin) and permits determination of the minimum effective dose for the individual patient. Sufficient time should be given to assess adequacy of therapeutic response. Fasting plasma glucose (FPG) should be used to determine the therapeutic response to AVANDAMET.

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