Pioglitazone instructions for administration

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Phone:617-632-7753

Instructions for administration

Monotherapy

Combination Therapy

• Sulfonylureas
• Metformin
• Insulin
• Maximum Recommended Dose

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Monotherapy

ACTOS monotherapy in patients not adequately controlled with diet and exercise may be initiated at 15 mg or 30 mg once daily. For patients who respond inadequately to the initial dose of ACTOS, the dose can be increased in increments up to 45 mg once daily. For patients not responding adequately to monotherapy, combination therapy should be considered. Return to top

Sulfonylureas

ACTOS in combination with a sulfonylurea may be initiated at 15 mg or 30 mg once daily. The current sulfonylurea dose can be continued upon initiation of ACTOS therapy. If patients report hypoglycemia, the dose of the sulfonylurea should be decreased. Return to top

Metformin

ACTOS in combination with metformin may be initiated at 15 mg or 30 mg once daily. The current metformin dose can be continued upon initiation of ACTOS therapy. It is unlikely that the dose of metformin will require adjustment due to hypoglycemia during combination therapy with ACTOS. Return to top

Insulin

ACTOS in combination with insulin may be initiated at 15 mg or 30 mg once daily. The current insulin dose can be continued upon initiation of ACTOS therapy. In patients receiving ACTOS and insulin, the insulin dose can be decreased by 10% to 25% if the patient reports hypoglycemia or if plasma glucose concentrations decrease to less than 100 mg/dL. Further adjustments should be individualized based on glucoselowering response. Return to top

Maximum Recommended Dose

The dose of ACTOS should not exceed 45 mg once daily since doses higher than 45 mg once daily have not been studied in placebo-controlled clinical studies. No placebocontrolled clinical studies of more than 30 mg once daily have been conducted in combination therapy. Dose adjustment in patients with renal insufficiency is not recommended. Therapy with ACTOS should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT greater than 2.5 times the upper limit of normal) at start of therapy. Liver enzyme monitoring is recommended in all patients prior to initiation of therapy with ACTOS and periodically thereafter. There are no data on the use of ACTOS in patients under 18 years of age; therefore, use of ACTOS in pediatric patients is not recommended. No data are available on the use of ACTOS in combination with another thiazolidinedione. Return to top

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The content of this page is taken from the FDA package insert for this drug and should not be edited.