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Genaral: Sitagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Pancreatitis: There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic and necrotizing pancreatitis associated with sitagliptin use. Monitor for signs/symptoms of pancreatitis. Discontinue use immediately if pancreatitis is suspected and initiate appropriate management. Use with caution in patients with a history of pancreatitis.
Use in Patients with Renal Impairment: Use with caution in patients with moderate to severe renal dysfunction and end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, dosing adjustment required.
Hypoglycemia in combination with a Sulfonylurea or with insulin: When Sitagliptin was used in combination with a sulfonylurea or insulin, the incidence of hypoglycemia was greater than that in patients receiving placebo with a sulfonylurea or insulin. Patients receiving sitagliptin may require a lower dosage of a concomitant insulin secretagogue (e.g., Sulfonylurea) or insulin to reduce the risk of hypoglycemia.
Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, angioedema, and exfoliative skin reactions, such as Stevens-Johnson syndrome, have been reported. Discontinue if signs/symptoms of hypersensitivity reactions occur. Use with caution if patient has experienced angioedema with other DPP-4 inhibitor use.
Bullous Pemphigoid: DPP-4 inhibitor use has been associated with development of bullous pemphigoid; cases have typically resolved with topical or systemic immunosuppressive therapy and discontinuation of DPP-4 inhibitor therapy. Discontinue therapy if bullous pemphigoid is suspected and consider referral to a dermatologist.
