Siglivia Special Precautions

Sitagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis have been occur in patients taking Sitagliptin. 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.
Sitagliptin is renally excreted. Lower dosage are recommended in patients with eGFR <45 mL/min/1.73 m², as well as in ESRD patients requiring hemodialysis or peritoneal dialysis to achieve plasma concentrations of Sitagliptin similar to those in patients with normal renal function.
Hypoglycemia has been observed when Sitagliptin was used in combination with insulin or a sulfonylurea. Therefore, to reduce the risk of sulfonylurea- or insulin induced hypoglycemia, a lower dose of sulfonylurea or insulin may be considered.
Serious hypersensitivity reactions have been occurred in patients treated with Sitagliptin including anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Onset of these reactions occurred within the first 3 months after initiation of treatment with Sitagliptin, but such reactions may occur after the first dose. If a hypersensitivity reaction is suspected, discontinue Sitagliptin, assess for other potential causes for the event, and institute alternative treatment for diabetes.
Bullous pemphigoid requiring hospitalization have been occurred with DPP-4 inhibitor use. Patients in such cases usually recovered after discontinuation of the DPP-4 inhibitor and treatment with topical or systemic immunosuppressive therapy. Patients should be advised to report the 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.
Effects on ability to drive and use machines: Sitagliptin has no or negligible influence on the ability to drive and use machines. However, when driving or using machines, it should be taken into account that dizziness has been occurred. In addition, patients should be alerted to the risk of hypoglycemia when Sitagliptin is used in combination with a sulfonylurea or with insulin.