Usual Adult Dose for Diabetes Type 2

Usual dose: 25 mg orally once a day

Comments: When used in combination with insulin or insulin secretagogues such as sulfonylureas, a lower dose of insulin or the insulin secretagogue may be required to minimize the risk of hypoglycemia.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; may be used as monotherapy or in combination therapy .

Renal Dose Adjustments

Mild Renal Impairment (CrCl 60 mL/min or greater): No adjustment recommended
Moderate Renal Impairment (CrCl 30 to 60 mL/min): 12.5 mg orally once a day
Severe Renal Impairment (CrCl 15 mL to less than 30 mL/min): 6.25 mg orally once a day
ESRD (CrCl less than 15 mL/min): 6.25 mg orally once a day

Liver Dose Adjustments

Mild to moderate liver dysfunction (Child-Pugh Grade A and B): No adjustment recommended
Severe liver dysfunction (Child-Pugh C): Data not available. Use caution

• If liver injury is detected, promptly interrupt therapy and assess for probable cause.
• If liver injury is confirmed and no alternative etiology is found, do not restart this drug.

Dose Adjustments

If used in combination with insulin or an insulin secretagogue such as sulfonylureas, a lower dose of insulin or the insulin secretagogue may be required to minimize the risk of hypoglycemia.

Precautions

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

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: 6.25 mg orally once a day; may be administered without regard to the timing of dialysis
Peritoneal dialysis: Data not available

Other Comments

Administration advice:

• Take orally once a day
• May take with or without food

• May be used as monotherapy or in combination therapy in adults with type 2 diabetes mellitus.
• Not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings.

• Cardiovascular: Signs and symptoms of heart failure
• Renal: Assess renal function at baseline and periodically during therapy
• Hepatic: Signs and symptoms of hepatotoxicity
• Monitor for signs and symptoms of pancreatitis
• Monitor glycemic control

• Patients should be informed that acute pancreatitis, heart failure, allergic reactions, and liver injury have occurred with use of this drug; they should understand the importance of reporting signs and symptoms of these conditions and when to promptly seek medical attention.
• Patients should understand the importance of adhering to dietary instructions and regular physical activity; they should be able to recognize the signs and symptoms of high and low blood sugar and how to treat.
• 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.
• Instruct patients to contact their health care provider if they develop severe and persistent joint pain or if blisters or erosions occur on skin.