Monotherapy: Adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM. Combination therapy: PPARγ agonist (eg, thiazolidinediones) or metformin as initial therapy or when the single agent alone, w/ diet & exercise does not provide adequate glycemic control. Combination w/ a sulfonylurea: Patients w/ type 2 DM to improve glycemic control when treatment w/ single agent alone, w/ diet & exercise, does not provide adequate glycemic control. Combination w/ metformin & a sulfonylurea or metformin & PPARγ agonists: Patients w/ type 2 DM to improve glycemic control when dual therapy w/ these agents, does not provide adequate glycemic control. Combination w/ insulin: Adjunct to diet & exercise to improve glycemic control in combination w/ insulin (w/ or w/o metformin).
Monotherapy or combination therapy w/ metformin, sulfonylurea, insulin (w/ or w/o metformin), PPARγ agonist, metformin plus sulfonylurea or metformin plus PPARγ agonist 100 mg once daily. Patients w/ renal impairment Mild renal impairment (eGFR ≥60 to <90 mL/min/1.73 m2) to moderate renal impairment (eGFR ≥45 to <60 mL/min/1.73 m2): No dosage adjustment is required. Moderate renal impairment (eGFR ≥30 to <45 mL/min/1.73 m2): 50 mg once daily. Severe renal impairment (eGFR ≥15 to <30 mL/min/1.73 m2) or ESRD (eGFR <15 mL/min/1.73 m2) requiring hemodialysis or peritoneal dialysis: 25 mg once daily. May be administered w/o regards to the timing of dialysis. Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of therapy & periodically thereafter.
Not to be used in patients w/ type 1 DM or for the treatment of diabetic ketoacidosis. Patients w/ renal impairment. To achieve plasma conc of sitagliptin phosphate similar to those patients w/ normal renal function, lower dosages are recommended in patients w/ eGFR <45 mL/min/1.73 m2, as well as in ESRD patients requiring hemodialysis or peritoneal dialysis. Lower dose of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia. Patients should be informed of the characteristic symptom of acute pancreatitis: Persistent, severe abdominal pain. Hypersensitivity reactions. Discontinue if pancreatitis, bullous pemphigoid or hypersensitivity reaction is suspected. Pregnancy & lactation. Elderly. Childn <18 yr.
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