Glucovance Indications, Dosage, Storage, Stability - Glyburide and Metformin

Glucovance Indications, Dosage, Storage, Stability - Glyburide and Metformin

INDICATIONS

GLUCOVANCE is indicated as initial therapy, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone.

GLUCOVANCE is indicated as second-line therapy when diet, exercise, and initial treatment with a sulfonylurea or metformin do not result in adequate glycemic control in patients with type 2 diabetes.

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 20 mg glyburide/2000 mg metformin. GLUCOVANCE (Glyburide and Metformin HCl Tablets) should be given with meals and should be initiated at a low dose, with gradual dose escalation as described below, in order to avoid hypoglycemia (largely due to glyburide), to reduce GI 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 to 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 normal as possible. Ideally, the response to therapy should be evaluated using HbA _1c (glycosylated hemoglobin), 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 glyburide (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 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 effective 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.

Specific Patient Populations

GLUCOVANCE is not recommended for use during pregnancy or for use in pediatric patients. The initial and maintenance dosing of GLUCOVANCE should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment requires a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of GLUCOVANCE to avoid the risk of hypoglycemia. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly. (See WARNINGS.)

GLUCOVANCE®

GLUCOVANCE 1.25 mg/250 mg tablet is a pale yellow, capsule-shaped, bevel edged, biconvex film-coated tablet with "BMS" debossed on one side and "6072" debossed on the opposite side.

GLUCOVANCE 2.5 mg/500 mg tablet is a pale orange, capsule-shaped, bevel edged, biconvex film-coated tablet with "BMS" debossed on one side and "6073" debossed on the opposite side.

GLUCOVANCE 5 mg/500 mg tablet is a yellow, capsule-shaped, bevel edged, biconvex film-coated tablet with "BMS" debossed on one side and "6074" debossed on the opposite side.

STORAGE

Store at temperatures up to 25° C (77° F). [See USP Controlled Room Temperature.] Dispense in light resistant containers.

GLUCOVANCE™ is a trademark of LIPHA s.a. Licensed to Bristol-Myers Squibb Company.

Micronase® is a registered trademark of Pharmacia & Upjohn Company.