Glucovance Dosage/Direction for Use

General Considerations: Dosage of Glucovance must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of glibenclamide 20 mg/metformin 2000 mg. Glucovance should be given with meals and should be initiated at a low dose, with gradual dose escalation, in order to avoid hypoglycemia (largely due to glibenclamide), to reduce gastrointestinal side effects (largely due to metformin) and to permit determination of the minimum effective dose for adequate control of blood glucose for the individual patient.
With initial treatment and during dose titration, appropriate blood glucose monitoring should be used to determine the therapeutic response of Glucovance and to identify the minimum effective dose for the patient. Thereafter, HbA_1c should be measured at intervals of approximately 3 months to assess the effectiveness of therapy. The therapeutic goal in all patients with type 2 diabetes is to decrease FPG, PPG and HbA_1c to normal or as near to normal as possible. Ideally, the response to therapy should be evaluated using HbA_1c, which is a better indicator of long-term glycemic control than FPG alone.
No studies have been performed specifically examining the safety and efficacy of switching to Glucovance therapy in patients taking concomitant glibenclamide (or other sulfonylurea) plus metformin. Changes in glycemic control may occur in such patients, with either hyperglycemia or hypoglycemia possible. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring.
Glucovance as Initial Therapy: 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 daily with a meal. As initial therapy in patients with baseline HbA_1c >8% 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 daily every 2 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 >10 mg/2000 mg daily.
Glucovance Use in Previously Treated Patients (Second-Line Therapy): Recommended Starting Dose: 2.5 mg/500 mg twice daily with meals.
For patients not adequately controlled on either glibenclamide (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 glibenclamide or metformin already being taken. The daily dose should be titrated in increments of not more than 5 mg/500 mg up to the minimum effective dose to achieve adequate control of blood glucose or to a maximum dose of 20 mg/2000 mg daily.
For patients previously treated with combination therapy of glibenclamide (or another sulfonylurea) plus metformin, if switched to Glucovance, the starting dose should not exceed the daily dose of glibenclamide (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 previously to achieve adequate control of blood glucose.