Uses
Diabetes Mellitus
Used alone or in fixed combination with metformin as an adjunct to diet and exercise for the management of type 2 (noninsulin-dependent) diabetes mellitus in patients whose hyperglycemia cannot be controlled by diet alone.
Used in combination with one or more other oral antidiabetic agents or insulin as an adjunct to diet and exercise in patients who do not achieve adequate glycemic control with diet, exercise, and oral antidiabetic agent monotherapy.
Alternative therapy in some type 2 diabetic patients being treated with insulin. Useful in combination with insulin therapy to improve glycemic control and/or decrease insulin dosage in some type 2 diabetic patients.
Not effective as sole therapy for patients with type 1 diabetes mellitus; insulin is necessary.
Not effective as sole therapy in patients with diabetes mellitus complicated by acidosis, ketosis, or coma; insulin is necessary.
Dosage and Administration
General
- Adjust dosage according to patient’s tolerance and urine and/or fasting blood glucose determinations. Monitor glycosylated hemoglobin (hemoglobin A1c, HbA1c) to determine minimum effective dosage and to detect primary or secondary failure.
- During transfer from insulin therapy, patients should test their blood for glucose and their urine for glucose and/or ketones at least 3 times daily. Persistent ketonuria with glycosuria, ketosis, and/or inadequate lowering or persistent elevation of blood glucose concentration during transfer from insulin indicate the need for insulin therapy.
- Micronized formulations are not bioequivalent with conventional formulations; retitrate dosage when transferring patients from micronized to conventional formulations, or vice versa.
Administration
Oral Administration
Administer conventional or micronized formulations once daily with breakfast or first main meal. May administer in 2 divided doses in some patients (i.e., those receiving >10 mg daily [as conventional formulations] or >6 mg [as micronized glyburide]).
Administer fixed combination with metformin hydrochloride once or twice daily with a meal.
Dosage
Adults
Diabetes Mellitus
Initial Dosage in Previously Untreated Patients
Oral
Conventional formulations: Initially, 2.5–5 mg daily.
Micronized formulations: Initially, 1.5 –3 mg daily.
Fixed combination with metformin hydrochloride: Initially, 1.25 mg of glyburide and 250 mg of metformin hydrochloride once daily. For severe hyperglycemia (baseline HbA1c >9% or fasting blood glucose >200 mg/dL), 1.25 mg of glyburide and 250 mg of metformin hydrochloride twice daily, given with the morning and evening meals.
Initial Dosage in Patients Transferred from Other Oral Antidiabetic Agents
Oral
Conventional formulations: Initially, 2.5–5 mg daily.
Micronized formulations: Initially, 1.5–3 mg daily.
May discontinue most other oral hypoglycemic agents (except chlorpropamide) immediately. During transfer from chlorpropamide (a drug with a long elimination half-life), monitor closely for hypoglycemia during initial 2 weeks of transition period.
Fixed combination with metformin hydrochloride: Initially, 2.5 or 5 mg of glyburide and 500 mg of metformin hydrochloride twice daily with morning and evening meals in patients not adequately controlled by monotherapy with glyburide (or another sulfonylurea) or metformin. For patients previously receiving combination therapy with glyburide (or another sulfonylurea) and metformin, initial dosage should not exceed previous individual dosages of glyburide (or equivalent dosage of another sulfonylurea) and metformin. Titrate in increments ≤5 mg of glyburide and 500 mg of metformin hydrochloride to achieve adequate blood glucose control.
Initial Dosage in Patients Transferred from Insulin
Oral
Conventional formulations: Initially, 2.5–5 mg once daily (if insulin dosage is <20 units daily) or 5 mg once daily (if insulin dosage is 20–40 units daily); may discontinue insulin immediately. If insulin dosage is >40 units daily, reduce insulin dosage by 50% and initiate glyburide at 5 mg daily; withdraw insulin gradually and increase glyburide dosage in increments of 1.25–2.5 mg daily every 2–10 days.
Micronized formulations: Initially, 1.5–3 mg once daily (if insulin dosage is <20 units daily) or 3 mg once daily (if insulin dosage is 20–40 units daily); may discontinue insulin immediately. If insulin dosage is >40 units daily, reduce insulin dosage by 50% and initiate glyburide at 3 mg daily; withdraw insulin gradually and increase glyburide dosage in increments of 0.75–1.5 mg daily every 2–10 days.
Titration and Maintenance Dosage
Oral
Conventional formulations: Increase dosage in increments of ≤2.5 mg daily at weekly intervals. Usual maintenance dosage is 1.25–20 mg daily.
Micronized formulations: Increase dosage in increments of ≤1.5 mg daily at weekly intervals. Usual maintenance dosage is 0.75–12 mg daily.
Fixed combination with metformin hydrochloride: Titrate in increments of 1.25 mg of glyburide and 250 mg of metformin hydrochloride daily at 2-week intervals to achieve adequate blood glucose control.
Prescribing Limits
Adults
Conventional formulations: Maximum 20 mg daily.
Micronized formulations: Maximum 12 mg daily.
Fixed combination with metformin hydrochloride: Maximum 20 mg of glyburide and 2 g of metformin hydrochloride daily.
Special Populations
Dosage in Hepatic Impairment
Conventional formulations: Initially, 1.25 mg daily.
Micronized formulations: Initially, 0.75 mg daily.
Dosage in Renal Impairment
Conventional formulations: Initially, 1.25 mg daily.
Micronized formulations: Initially, 0.75 mg daily.
Geriatric Patients
Conventional formulations: Initially, 1.25 mg daily
Micronized formulations: Initially, 0.75 mg daily.
Fixed combination with metformin hydrochloride: Do not titrate to maximum recommended dosage.
Other Populations
Cautious dosing recommended in debilitated or malnourished patients or in patients with adrenal or pituitary insufficiency.
Conventional formulations: Initially, 1.25 mg daily
Micronized formulations: Initially, 0.75 mg daily.
Fixed combination with metformin hydrochloride: Do not titrate to maximum recommended dosage.
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