Adivia Special Precautions





InnoGen Pharmaceuticals
Full Prescribing Info
Special Precautions
Sitagliptin should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Pancreatitis: In post-marketing experience, there have been reports of acute pancreatitis including fatal and nonfatal hemorrhagic or necrotizing pancreatitis in patients taking Sitagliptin. Because these reports are made voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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 phosphate and other potentially suspect medicinal products should be discontinued.
Use in Patients with Renal Insufficiency: Sitaglipin 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 moderate and severe renal insufficiency, as well as in ESRD patients requiring hemodialysis or peritoneal dialysis.
Hypoglycemia in Combination with a Sulfonylurea or Insulin: Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Sitagliptin and periodically thereafter.
As is typical with other antihyperglycemic agents, when Sitagliptin was used in combination with a sulfonylurea or with insulin, a medication known to cause hypoglycemia, the incidence of sulfonylurea- or insulin-induced hypoglycemia was increased over that of placebo. Therefore, to reduce the risk of sulfonylurea- or insulin-induced hypoglycemia, a lower dose of sulfonylurea or insulin may be considered.
Hypersensitivity Reactions: There have been post-marketing reports of serious hypersensitivity reactions in patients treated with Sitagliptin. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Onset of these reactions occurred within the first 3 months after initiation of treatment with Sitagliptin, with some reports occurring after the 1st dose. If a hypersensitivity reaction is suspected, discontinue Sitagliptin, assess for other potential causes for the event, and institute alternative treatment for diabetes.
Use in Children: Safety and effectiveness of Sitagliptin in pediatric patients <18 years have not been established.
Use in 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 insufficiency; as with other patients, dosage adjustment may be required in the presence of significant renal insufficiency.
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