Sita Special Precautions

General: Sitagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Pancreatitis: Patients should be informed about 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 Insufficiency: Sitagliptin is excreted renally. To achieve plasma concentrations of Sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with moderate and severe renal insufficiency, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis.
Hypoglycaemia in Combination with a Sulfonylurea: As is typical with other anti-hyperglycaemic agents used in combination with a sulfonylurea, when Sitagliptin was used in combination with a sulfonylurea, a medication known to cause hypoglycaemia, the incidence of sulfonylurea-induced hypoglycaemia was increased over that of placebo. Therefore, to reduce the risk of sulfonylurea-induced hypoglycaemia, a lower dose of sulfonylurea may be considered. The use of Sitagliptin in combination with insulin has not been adequately studied.
Hypersensitivity Reactions: There have been reports of serious hypersensitivity reactions in patients treated with Sitagliptin. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. If a hypersensitivity reaction is suspected, discontinue Sitagliptin, assess for other potential causes for the event, and institute alternative treatment for diabetes.
Use in Pregnancy: There are no adequate and well-controlled studies in pregnant women; therefore, the safety of Sitagliptin in pregnant women is not known.
Use in Lactation: Sitagliptin is secreted in the milk of lactating rats. It is not known whether Sitagliptin is secreted in human milk. Therefore, Sitagliptin should not be used by a woman who is nursing.
Use in Children: Safety and effectiveness of Sitagliptin in paediatric 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 insufficiency; as with other patients, dosage adjustment may be required in the presence of significant renal insufficiency.