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Glucovance

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Glucovance

Glucovance

INDICATIONS

GLUCOVANCE (Glyburide and Metformin HC1) Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

DOSAGE AND ADMINISTRATION

General Considerations

Dosage of GLUCOVANCE (glyburide and metformin) 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) 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), reduce GI side effects (largely due to metformin), and 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 (glyburide and metformin) and to identify the minimum effective dose for the patient. Thereafter, HbA1c 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 HbAic to normal or as near normal as possible. Ideally, the response to therapy should be evaluated using HbA1c (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 (glyburide and metformin) 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 (glyburide and metformin) in Patients with Inadequate Glycemic Control on Diet and Exercise

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 (glyburide and metformin) is 1.25 mg/250 mg once a day with a meal. As initial therapy in patients with baseline HbA1c > 9% or an FPG > 200 mg/dL, a starting dose of GLUCOVANCE (glyburide and metformin) 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 2 weeks up to the minimum effective dose necessary to achieve adequate control of blood glucose. In clinical trials of GLUCOVANCE (glyburide and metformin) as initial therapy, there was no experience with total daily doses > 10 mg/2000 mg per day. GLUCOVANCE (glyburide and metformin) 5mg/500mg should not be used as initial therapy due to an increased risk of hypoglycemia.

GLUCOVANCE (glyburide and metformin) Use in Patients with Inadequate Glycemic Control on a Sulfonylurea and/or Metformin

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 (glyburide and metformin) 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 (glyburide and metformin) 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 (glyburide and metformin) , 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 (glyburide and metformin) should be titrated as described above to achieve adequate control of blood glucose.

Addition of Thiazolidinediones to GLUCOVANCE (glyburide and metformin) Therapy

For patients not adequately controlled on GLUCOVANCE (glyburide and metformin) , a thiazolidinedione can be added to GLUCOVANCE (glyburide and metformin) therapy. When a thiazolidinedione is added to GLUCOVANCE (glyburide and metformin) therapy, the current dose of GLUCOVANCE (glyburide and metformin) can be continued and the thiazolidinedione initiated at its recommended starting dose. For patients needing additional glycemic control, the dose of the thiazolidinedione can be increased based on its recommended titration schedule. The increased glycemic control attainable with GLUCOVANCE (glyburide and metformin) plus a thiazolidinedione may increase the potential for hypoglycemia at any time of day. In patients who develop hypoglycemia when receiving GLUCOVANCE (glyburide and metformin) and a thiazolidinedione, consideration should be given to reducing the dose of the glyburide component of GLUCOVANCE (glyburide and metformin) . As clinically warranted, adjustment of the dosages of the other components of the antidiabetic regimen should also be considered.

Specific Patient Populations

GLUCOVANCE (glyburide and metformin) is not recommended for use during pregnancy. The initial and maintenance dosing of GLUCOVANCE (glyburide and metformin) 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 (glyburide and metformin) 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.)

HOW SUPPLIED

GLUCOVANCE® (Glyburide and Metformin HC1) Tablets

GLUCOVANCE (glyburide and metformin) 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 (glyburide and metformin) 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 (glyburide and metformin) 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.

GLUCOVANCE NDC 0087-xxxx-xx for unit of use
Glyburide (mg) Metformin hydrochloride (mg) Bottle of 100
1.25 250 6072-11
2.5 500 6073-11
5 500 6074-11

Storage

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

Dispense in light-resistant containers.

Distributed by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA. Rev May 2010

Last reviewed on RxList: 1/11/2011
This monograph has been modified to include the generic and brand name in many instances.

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