Avandia

[Rosiglitazone maleate]

Sulfonylurea:

When used in combination with sulfonylurea, the recommended 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.

Metformin:

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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. It is unlikely that the dose of metformin will require adjustment due to hypoglycemia during combination therapy with AVANDIA.

Insulin:

For patients stabilized on 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.

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. Doses of AVANDIA greater than 4 mg daily in combination with a sulfonylurea have not been studied in adequate and well-controlled clinical trials. Doses of AVANDIA greater than 4 mg daily in combination with insulin are not currently indicated.

AVANDIA may be taken with or without food.

No dosage adjustments are required for the elderly.

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. 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) (see PRECAUTIONS, General, Hepatic Effects and CLINICAL PHARMACOLOGY, Special Populations, Hepatic Impairment).

Liver enzyme monitoring is recommended in all patients prior to initiation of therapy with AVANDIA and periodically thereafter (see PRECAUTIONS, General, Hepatic Effects).

There are no data on the use of AVANDIA in patients younger than 18 years; therefore, use of AVANDIA in pediatric patients is not recommended.

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