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Glucovance

[Glyburide/Metformin]

No studies have been performed specifically examining the safety and efficacy of switching to GLUCOVANCE therapy in patients taking concomitant glyburide (or other sulfonylurea) plus met-formin. Changes in glycemic control may occur in such patients, with either hyperglycemia or hypo-glycemia possible. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring.

GLUCOVANCE

As Initial Therapy

Text Continues Below



Recommended starting dose: 1.25 mg/ 250 mg once or twice daily with meals. For patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone, the recommended starting dose of GLUCOVANCE is 1.25 mg/ 250 mg once a day with a meal. As initial therapy in patients with baseline HbA 1c >9% or an FPG >200 mg/ dL, a starting dose of GLUCOVANCE 1.25 mg/ 250 mg twice daily with the morning and evening meals may be used. Dosage increases should be made in increments of 1.25 mg/ 250 mg per day every two weeks up to the minimum effective dose necessary to achieve adequate control of blood glucose.

In clinical trials of GLUCOVANCE as initial therapy, there was no experience with total daily doses greater than 10 mg/ 2000 mg per day. GLUCOVANCE 5 mg/ 500 mg should not be used as initial therapy due to an increased risk of hypoglycemia.

GLUCOVANCE

Use in Previously Treated Patients (Second-Line Therapy)

Recommended starting dose: 2.5 mg/ 500 mg or 5 mg/ 500 mg twice daily with meals. For patients not adequately controlled on either glyburide (or another sulfonylurea) or metformin alone, the recommended starting dose of GLUCOVANCE is 2.5 mg/ 500 mg or 5 mg/ 500 mg twice daily with the morning and evening meals.

In order to avoid hypoglycemia, the starting dose of GLUCOVANCE should not exceed the daily doses of glyburide or metformin already being taken. The daily dose should be titrated in increments of no more than 5 mg/ 500 mg up to the minimum effec-tive dose to achieve adequate control of blood glucose or to a maximum dose of 20 mg/ 2000 mg per day. For patients previously treated with combination therapy of glyburide (or another sulfonylurea) plus metformin, if switched to GLUCOVANCE, the starting dose should not exceed the daily dose of glyburide (or equivalent dose of another sulfonylurea) and metformin already being taken. Patients should be monitored closely for signs and symptoms of hypoglycemia following such a switch and the dose of GLUCOVANCE should be titrated as described above to achieve adequate control of blood glucose.

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