Usual Adult Dose for Diabetes Type 2

Individualize dose based on efficacy and tolerability:

Initial dose: 25 mg orally 3 times a day

• Adjust dose at 4 to 8 week intervals based on efficacy and tolerability

Maintenance dose: 50 mg to 100 mg orally 3 times a day
Maximum dose: Weight 60 kg or less: 50 mg orally 3 times a day; Weight greater than 60 kg: 100 mg orally 3 times a day

Comments:

• Take at the start (with first bite) of each main meal; patients should be adhering to a diabetic diet to minimize GI side effects.
• Some patients benefit from starting at 25 mg orally once a day with subsequent titration to 3 times a day to minimize GI side effects.
• If no further reduction in postprandial glucose or HbA1c is observed with titration to 100 mg three times a day, consider lowering the dose.

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

Renal Dose Adjustments

Significant renal dysfunction (serum creatinine greater than 2 mg/dL): Use is not recommended

Liver Dose Adjustments

Use with caution

If elevated transaminase levels develop: Dose reduction or withdrawal of therapy may be necessary, especially if elevations persist.

Dose Adjustments

Gastrointestinal Adverse Effects:

• If gastrointestinal symptoms persist despite following a prescribed diet, dose reduction or discontinuation may be necessary.

Hypoglycemia:

• When given in combination with sulfonylurea agents or insulin, hypoglycemia may occur, if this occurs, dose adjustment of the sulfonylurea agent or insulin will be necessary.

Body Weight of 60 kg or less: Maximum recommended dose is 50 mg orally 3 times a day because of increased risk for elevated serum transaminases.

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 at the start of meal (with first bite)

General:

• This drug should be titrated to reduce gastrointestinal side effects; patients should be instructed regarding the importance of following a diabetic diet.
• This drug may be used as monotherapy, or in combination with other antidiabetic agents.
• Patients receiving sulfonylureas or insulin may need a dose adjustment of these agents if hypoglycemia occurs.

Monitoring:

• Glycemic control: During initiation and titration, 1-hour postprandial plasma glucose should be used to monitor therapeutic response; glycosylated hemoglobin levels (HbA1c) should be measured every 3 months to assess long-term glycemic control.
• Hepatic: Serum transaminases should be checked every 3 months for the first year and periodically thereafter.

Patient advice:

• Patients should understand the importance of adhering to a diabetic diet; gastrointestinal side effects are common upon treatment initiation, but should diminish with time.
• Hypoglycemia may occur, more commonly when used in combination with insulin or a sulfonylurea; patients should be instructed to treat hypoglycemia with oral glucose (dextrose) as sucrose (cane sugar) is not expected to correct hypoglycemia due to this drug inhibiting breakdown to glucose and fructose.
• 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.