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The management of antidiabetic therapy should be individualized. Rosiglitazone 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, sulfonylurea, or sulfonylurea plus metformin. Rosiglitazone may be taken with or without food.
Monotherapy: The usual starting dose of Rosiglitazone 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 Rosiglitazone is added to existing therapy, the current dose(s) of the agent(s) can be continued upon initiation of Rosiglitazone therapy.
Sulfonylurea: When used in combination with sulfonylurea, the usual starting dose of Rosiglitazone is 4 mg administered as either a single dose once daily or in divided doses twice daily. If patients report hypoglycemia, the dose of the sulfonylurea should be decreased.
Metformin: The usual starting dose of Rosiglitazone in combination with metformin is 4 mg administered as either a single dose once daily or in divided doses twice daily. It is unlikely that the dose of metformin will require adjustment due to hypoglycemia during combination therapy with Rosiglitazone.
Insulin: For patients stabilized on insulin, the insulin dose should be continued upon initiation of therapy with Rosiglitazone. Rosiglitazone should be dosed at 4 mg daily. Doses of Rosiglitazone greater than 4 mg daily in combination with insulin are not currently indicated. It is recommended that the insulin dose be decreased by 10% to 25% if the patient reports hypoglycemia or if FPG concentrations decrease to less than 100 mg/dL. Further adjustments should be individualized based on glucose-lowering response.
Sulfonylurea plus metformin: The usual starting dose of Rosiglitazone in combination with a sulfonylurea plus metformin is 4 mg administered as either a single dose once daily or in divided doses twice daily. If patients report hypoglycemia, the dose of the sulfonylurea should be decreased.
Maximum Recommended Dose: The dose of Rosiglitazone should not exceed 8 mg daily, as a single dose or divided twice daily. The 8 mg daily dose has been shown to be safe and effective in clinical studies as monotherapy and in combination with metformin, sulfonylurea, or sulfonylurea plus metformin. Doses of Rosiglitazone greater than 4 mg daily in combination with insulin are not currently indicated. No dosage adjustments are required for the elderly. No dosage adjustment is necessary when Rosiglitazone is used as monotherapy in patients with renal impairment.
Use in Children: The safety and effectiveness of Rosiglitazone in pediatric patients have not been established.
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