Sitagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Pancreatitis: There have been reports of acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis (see Adverse Reactions), in patients taking sitagliptin. After initiation of sitagliptin, patients should be observed carefully for signs and symptoms of pancreatitis. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. Resolution of pancreatitis has been observed after discontinuation of sitagliptin. If pancreatitis is suspected, sitagliptin, and other potentially suspect medicinal products, should be discontinued.
Use in patients with renal impairment: A dosage adjustment is recommended in patients with eGFR <45 ml/minute/1.73 m2), as well as in ESRD patients requiring hemodialysis or peritoneal dialysis. (See Special populations: Patients with renal impairment under Dosage & Administration.)
Use with medications known to cause hypoglycemia: As is typical with other antihyperglycemic agents, hypoglycemia has been observed when sitagliptin was used in combination with insulin or a sulfonylurea. Therefore, a lower dose of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.
Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with sitagliptin or any other antidiabetic drug.
Bullous pemphigoid: Cases of bullous pemphigoid requiring hospitalization have been reported with DPP-4 inhibitor use. In reported cases, patients typically recovered with topical or systemic immunosuppressive treatment and discontinuation of the DPP-4 inhibitor. Tell patients to report development of blisters or erosions while receiving sitagliptin. If bullous pemphigoid is suspected, sitagliptin should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment.
Use in Children: Safety and effectiveness of sitagliptin in pediatric patients have not been established.
Use in the Elderly: Sitagliptin is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly, and it may be useful to assess renal function in these patients prior to initiating dosing and periodically thereafter.
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