General: Sitagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Pancreatitis: Acute pancreatitis (persistent, severe abdominal pain characteristic symptom), including fatal and non-fatal hemorrhagic or necrotizing pancreatitis in patients taking sitagliptin has been reported. Resolution of pancreatitis has been observed after discontinuation of sitagliptin. If alleged of pancreatitis, sitagliptin and other potentially suspect medicinal products should be discontinued.
Hypoglycemia in combination with a Sulfonylurea or with Insulin: Hypoglycemia has been observed. A lower dose of sulfonylurea or insulin may be considered to reduce the risk of sulfonylurea - or insulin - induced hypoglycemia.
Hypersensitivity reactions: These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. If hypersensitivity occurs, discontinue sitagliptin, assess for other potential causes for the event, and institute alternative treatment for diabetes.
Bullous Pemphigoid: Patients should 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 patients with Renal Impairment: Sitagliptin is renally excreted. To achieve plasma concentrations of sitagliptin similar to those in patients, with normal renal function, lower dosages are recommended in patients with eGFR <45 mL/min/1.73 m2, as well as in ESRD patients requiring hemodialysis or peritoneal dialysis.
Use in Children: Safety and effectiveness of sitagliptin in pediatric patients under 18 years have not been established.
Use in the Elderly: No dosage adjustment is required based on age. Elderly patients are more likely to have renal impairment; as with other patients, dosage adjustment may be required in the presence of significant renal impairment.
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