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Merck Sharp & Dohme
[Natrapharm]
Regulatory Class: Rx
C: Sitagliptin phosphate
I: Adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM. In combination w/ PPAR-γ agonist (eg, thiazolidinediones) or metformin as initial therapy or when the single agent alone, w/ diet & exercise do not improve adequate glycemic control. Combination therapy w/ a sulfonylurea in patients w/ type 2 DM to improve glycemic control when treatment w/ single agent alone, w/ diet & exercise do not provide adequate glycemic control. In combination w/ metformin & sulfonylurea, metformin & PPAR-γ agonists (eg thiazolidinediones) when dual therapy w/ these agents does not provide adequate glycemic control. Adjunct to diet & exercise to improve glycemic control in combination w/ insulin (w/ or w/o metformin).
D: Monotherapy or combination therapy w/ metformin, sulfonylurea, insulin (w/ or w/o metformin), PPAR-γ agonist, metformin + sulfonylurea or metformin + PPAR-γ agonist 100 mg once daily.
A:
CI: Type 1 DM, diabetic ketoacidosis.
SP: Patients w/ renal insufficiency (including moderate & severe renal insufficiency), ESRD requiring hemodialysis or peritoneal dialysis. Assess renal function. Lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia. Hypersensitivity reactions. Inform patients on the symptomatic characteristic of acute pancreatitis. Pregnancy & lactation. Elderly. Childn <18 yr.
