Usual Adult Dose for Diabetes Type 2

Standard glyburide:

• Initial dose: 2.5 mg to 5 mg orally once a day
• Dose titration: Increase in increments of no more than 2.5 mg at weekly intervals based upon blood glucose response
• Maintenance dose: 1.25 to 20 mg orally as a single dose or in divided doses
• Maximum dose: 20 mg/day

Micronized glyburide:

• Initial dose: 1.5 mg to 3 mg orally once a day
• Dose titration: Increase in increments of no more than 1.5 mg at weekly intervals based upon blood glucose response
• Maintenance dose: 0.75 to 12 mg orally as a single dose or in divided doses
• Maximum dose: 12 mg/day

Comments:

• Administer with breakfast or the first main meal of the day
• Lower initial doses may be used in patients who are sensitive to hypoglycemic drugs
• Once a day therapy is generally satisfactory, however, some patients may have a more satisfactory response with twice-a-day dosing, especially those receiving higher doses.

TRANSFER FROM OTHER HYPOGLYCEMIC THERAPY:

• Oral Antidiabetic Therapy: No exact dosage relationships exists between standard glyburide, micronized glyburide, or other oral hypoglycemic agents; when transferring patients from other oral hypoglycemic therapy, the maximum starting doses should be observed.
• Insulin:
• If the insulin dose is less than 20 units per day substitute 2.5 to 5 mg (standard) OR 1.5 to 3 mg (micronized) orally once a day.
• If the insulin dose is between 20 and 40 units per day, substitute 5 mg (standard) OR 3 mg (micronized) orally once a day.
• If the insulin dose is more than 40 units per day; transition the patient by concomitantly decreasing insulin by 50% and starting glyburide at 5 mg (standard) OR 3 mg (micronized) orally once a day; as insulin is progressively withdrawn, titrate glyburide in increments of 1.25 to 2.5 mg (standard) OR 0.75 to 1.5 mg (micronized) orally once a day every 2 to 10 days.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Usual Geriatric Dose for Diabetes Type 2

Initial dose:
Standard: 1.25 to 2.5 mg orally once a day
Micronized: 0.75 to 1.5 mg orally once a day

Titration: See Adult Dosing

Renal Dose Adjustments

Use with caution; initial and maintenance doses should be conservative to avoid hypoglycemic reactions

• Initial dose: 1.25 mg (standard) or 0.75 mg (micronized) orally once a day

Liver Dose Adjustments

Use with caution; initial and maintenance doses should be conservative to avoid hypoglycemic reactions

• Initial dose: 1.25 mg (standard) or 0.75 mg (micronized) orally once a day

Dose Adjustments

Initial and maintenance doses should be conservative in patients at risk for serious hypoglycemic reactions

• Initial dose: 1.25 mg (standard) or 0.75 mg (micronized) orally once a day

Micronized glyburide tablets (Glynase Prestab) are not bioequivalent to standard glyburide formulations (DiaBeta, Micronase); patients should retitrate dose when transferring from one formulation to the other

No exact dosage relationship exists between glyburide and other oral hypoglycemic agents; however, a maintenance dose of glyburide 5 mg/day provides approximately the same degree of blood glucose control as chlorpropamide 250 to 375 mg/day, tolazamide 250 to 375 mg/day, acetohexamide 500 to 750 mg/day, or tolbutamide 1000 to 1500 mg/day.

• Patients should not exceed maximum starting doses when switching agents

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active substance or any product excipients
• Type 1 diabetes mellitus
• Diabetic ketoacidosis, with or without coma
• Concomitant administration of bosentan

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally once a day with first main meal of the day
• When coadministered with colesevelam, this drug should be taken at least 4 hours prior
• Missed doses should not be corrected by doubling the next dose. Measures for handling events such as missing a dose or skipping a meal should be agreed upon between the patient and their doctor.

General:

• Hypoglycemia may occur, especially in the elderly, debilitated, or malnourished patient, in patients receiving combination therapy, and/or those with renal, hepatic or adrenal insufficiency; dose reduction of this drug may be necessary.
• This drug should not be used in patients with type 1 diabetes or diabetic ketoacidosis.
• Hemolytic anemia may occur in glucose 6-phosphate dehydrogenase (G6PD) deficient patients; consider a non-sulfonylurea alternative.
• When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma infection, or surgery, it may be necessary to stop this drug and administer insulin.

Monitoring:
Regular clinical and laboratory evaluations are necessary to determine minimum effective dose and detect primary or secondary failure.

• Clinical status should be checked within the first 4 to 8 weeks and regularly, thereafter
• Laboratory monitoring including periodic fasting blood glucose, self-monitoring of blood glucose, and urine testing (i.e., glucose and ketones) should be done more frequently during drug initiation and with changing doses; glycosylated hemoglobin levels (HbA1c) should be done as clinically warranted.
• In the event of severe hypoglycemia, patients should be closely monitored for a minimum of 24 to 48 hours since hypoglycemia may recur after apparent clinical recovery.

Patient advice:

• Patients should understand the importance of exercise and dietary control in the management of their disease.
• Patients should understand that alcohol ingestion, intense or prolonged exercise, skipping meals, illness, or lifestyle changes may increase their risks for hypoglycemia; they should know how to recognize the symptoms of hypoglycemia and be prepared to treat it.
• Patients should be careful about driving and use of machinery, especially when at risk for hypoglycemia.
• Patients should speak with their health care provider during periods of stress such as fever, trauma, or illness, as their diabetes management may need to be changed.
• Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding.