Avoid use in type 1 diabetes mellitus (insulin dependent) and diabetic ketoacidosis due to lack of efficacy in those populations.
Worsening renal function, including acute renal failure, sometimes requiring dialysis has been reported.
Severe and disabling arthralgia has been reported with DPP-IV inhibitor use, onset may occur within one day to years after treatment initiation and may resolve with discontinuation of therapy.
Serious hypersensitivity reactions, including anaphylaxis, angioedema, and exfoliative skin reactions such as Stevens-Johnson syndrome, have been reported; discontinue if signs/symptoms of hypersensitivity reaction occur.
Case of acute pancreatitis (including hemorrhagic and necrotizing with some fatalities) have been reported with use; monitor for signs/symptoms of pancreatitis. (Severe and prolonged stomach pain) Discontinue use immediately if pancreatitis is suspected and initial appropriate management.
Use in Children: Safety and effectiveness of Sitagliptin in pediatric patients under 18 years have not been established.
Use in the Elderly: In clinical studies, the safety and effectiveness of Sitagliptin in the elderly (≥65 years) were comparable to those seen in younger patients (<65 years). 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 (see Dosage & Administration).
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