Applies to the following strength(s): 50 mg ; 25 mg ; 100 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Diabetes Type 2
Usual dose: 100 mg orally once a day
Comments: When used in combination with an insulin secretagogue (e.g. sulfonylurea) or insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia.
Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
Renal Dose Adjustments
Mild renal impairment (CrCl 50 mL/min or more): No adjustment recommended
Moderate renal impairment (CrCl 30 to less than 50 mL/min): 50 mg orally once a day
Severe renal impairment (CrCl less than 30 mL/min): 25 mg orally once a day
Approximate Corresponding Serum Creatinine Ranges:
-Mild renal impairment: Less than or equal to 1.7 mg/dL in men; less than or equal to 1.5 mg/dL in women
-Moderate renal impairment: Greater than 1.7 mg/dL to less than or equal to 3 mg/dL in men; greater than 1.5 mg/dL to less than or equal to 2.5 mg/dL in women.
-Severe renal impairment: Greater than 3 mg/dL in men; greater than 2.5 mg/dL in women.
Liver Dose Adjustments
Mild or moderate hepatic impairment: No adjustment recommended
Severe hepatic impairment: Use caution; no data available
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Hemodialysis: 25 mg orally once a day
Peritoneal dialysis: 25 mg orally once a day
-May be administered without regard to timing of dialysis
-May take with or without food
-Missed doses should be taken as soon as the patient remembers. More than one dose should not be taken on the same day.
-May be used as monotherapy and 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.
-Has not been studied in patients with a history of pancreatitis; it is unknown whether these patients may be at an increased risk for the development of pancreatitis.
-Monitor for signs and symptoms of pancreatitis
-Monitor glycemic control
-Renal function tests should be performed prior to starting therapy and periodically during therapy.
-Instruct patient to report signs and symptoms of pancreatitis; if persistent, severe abdominal pain occurs, seek medical advice promptly.
-Serious allergic reactions may occur; if symptoms occur, seek medical advice promptly.
-Hypoglycemia may occur, more commonly when used in combination with insulin or a sulfonylurea.
-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.
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- Other brands: Januvia