Rosiglitazone instructions for administration

Instructions for administration
Monotherapy Sulfonylurea Metformin Insulin Maximum Recommended Dose Special Populations(Geriatric) Hepatic Impairment

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(s) of the agent(s) can be continued upon initiation of AVANDIA therapy. Return to top

Sulfonylurea
When used in combination with sulfonylurea, the usual starting dose of AVANDIA 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. Return to top

Metformin
The usual starting dose of AVANDIA in combination with metformin is 4 mg administered as either a single dose once daily or in divided doses twice daily. Return to top

Insulin
The insulin dose should be continued upon initiation of therapy with AVANDIA. AVANDIA should be dosed at 4 mg daily. Doses of AVANDIA 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 AVANDIA in combination with a sulfonylurea plus metformin is 4 mg administered as either a single dose once daily or divided doses twice daily. If patients report hypoglycemia, the dose of the sulfonylurea should be decreased. Return to top

Maximum Recommended Dose
The dose of AVANDIA 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 AVANDIA greater than 4 mg daily in combination with insulin are not currently indicated. AVANDIA may be taken with or without food. Return to top

Special Populations(Geriatric)
No dosage adjustments are required for the elderly. Renal Impairment: No dosage adjustment is necessary when AVANDIA is used as monotherapy in patients with renal impairment. Since metformin is contraindicated in such patients, concomitant administration of metformin and AVANDIA is also contraindicated in patients with renal impairment. Return to top

Hepatic Impairment
Therapy with AVANDIA should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT >2.5X upper limit of normal at start of therapy). Liver enzyme monitoring is recommended in all patients prior to initiation of therapy with AVANDIA and periodically thereafter. Return to top