Instadip 50/Instadip 100 Special Precautions

General: Sitagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Pancreatitis: There have been reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis (see Adverse Reactions), in patients taking sitagliptin. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. Resolution of pancreatitis has been reported after discontinuation of sitagliptin. If pancreatitis is suspected, sitagliptin and other potentially suspect medicinal products should be discontinued.
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 (see Dosage & Administration).
Hypoglycemia in Combination with a Sulfonylurea or with Insulin: In reported clinical trials of sitagliptin as monotherapy and as part of combination therapy with agents not known to cause hypoglycemia (i.e. metformin or a PPARγ agonist (thiazolidinediones)), rates of hypoglycemia reported with sitagliptin were similar to rates in patients taking placebo. As is typical with other antihyperglycemic agents, hypoglycemia has been reported when sitagliptin was used in combination with insulin or a sulfonylurea (see Adverse Reactions). Therefore, to reduce the risk of sulfonylurea- or insulin-induced hypoglycemia, a lower dose of sulfonylurea or insulin may be considered (see Dosage & Administration).
Hypersensitivity Reactions: There have been postmarketing 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 first dose. If a hypersensitivity reaction is suspected, discontinue sitagliptin, assess for other potential causes for the event, and institute alternative treatment for diabetes (see Contraindications and Adverse Reactions).
Bullous Pemphigoid: Postmarketing cases of bullous pemphigoid requiring hospitalization have been reported with DPP-4 inhibitor use. In reported cases, patients typically recovered with topical or systemic immunosuppressive treatment and discontinuation of the DPP-4 inhibitor. Tell patients to 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.