Usual Adult Dose for Diabetes Type 2

Individualize therapy:
Dose preprandially 2, 3, or 4 times a day

• For patients not previously treated with antidiabetic agents or whose glycosylated hemoglobin (HbA1c) is less than 8%:

Initial dose: 0.5 mg orally with each meal

• For patients previously treated with antidiabetic agents or whose HbA1c is 8% or higher:

Initial dose: 1 or 2 mg orally with each meal

Dose Adjustments: Based upon blood glucose response, double the preprandial dose up to a maximum meal time dose of 4 mg until satisfactory glycemic response is achieved; allow at least 1 week to assess response after each dose adjustment.
Recommended Dose Range: 0.5 to 4 mg orally with each meal
Maximum Daily Dose: 16 mg per day

Comments:

• Fasting blood glucose concentrations are generally used to adjust doses, however, postprandial glucose levels may be used in patients whose pre-meal blood glucose levels are satisfactory but whose overall glycemic control (HbA1c) is inadequate.
• When hypoglycemia occurs in patients taking this drug in combination with a thiazolidinedione or metformin, the dose of this drug should be reduced.

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

Renal Dose Adjustments

Use with caution; allow longer intervals between dose adjustments to fully assess response.

Liver Dose Adjustments

Use with caution; allow longer intervals between dose adjustments to fully assess response.

Dose Adjustments

Debilitated or malnourished patients: Initial and maintenance dose should be conservative with careful dose titration

Patients switching from other oral hypoglycemic agents:

• When switching to this drug from another oral antidiabetic agent, this drug may be started the day after the final dose of the other oral antidiabetic agent; monitor patients carefully for overlapping drug effects.

Combination Therapy:

• If monotherapy does not result in adequate glycemic control, metformin or a thiazolidinedione may be added.
• This drug is not indicated for use in combination with NPH-insulin.

Hypoglycemia:

• If hypoglycemia occurs with concomitant use of thiazolidinedione or with metformin, the dose of repaglinide should be reduced.

Dose adjustments may be necessary with concomitant use of CYP450 2C8 and CYP450 3A4 inhibitors and inducers.

Precautions

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 before meals, usually within 15 minutes of a meal; however, may vary from immediately preceding meal to up to 30 minutes before a meal.
• Patients who skip a meal should be instructed to skip the dose for that meal; if an extra meal is taken, patients should be instructed to add a dose to cover the meal.

General:

• This drug may be used as monotherapy or in combination with metformin or a thiazolidinedione; this drug is not indicated for use in combination with NPH insulin.
• This drug is not indicated to treat patients with type 1 diabetes or diabetic ketoacidosis as these conditions should be treated with insulin.
• Short-term administration may be sufficient during periods of transient loss of control in patients usually well-controlled by diet.
• Secondary failure may occur; prior to classifying a patient as a secondary failure it is important to assess dose and dietary adherence.

Monitoring:

• Periodic measures of fasting blood glucose and glycosylated hemoglobin should be performed to assess efficacy.

Patient advice:

• Patients should understand the importance of adhering to dietary instructions and regular physical activity; during periods of stress such as fever, trauma, infection, or surgery, management of diabetes may change and patients should be advised to seek medical advice.
• Patients should be aware of the symptoms of hypoglycemia and be careful about driving and the use of machinery, especially when optimum stabilization has not been achieved, e.g., during a transition from other medications or during irregular use.
• Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding.