Xiglip

Sitagliptin phosphate

To improve glycemic control in adults w/ type 2 DM as monotherapy in patients inadequately controlled by diet & exercise alone & for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination w/ metformin when diet & exercise + metformin alone do not provide adequate glycemic control, w/ sulfonylurea when diet & exercise + max tolerated dose of sulfonylurea alone do not provide adequate glycemic control & when metformin is inappropriate due to contraindications or intolerance, or w/ peroxisome proliferator-activated receptor γ (PPARγ) agonist (ie, thiazolidinedione) when use of PPARγ agonist is appropriate & when diet & exercise + PPARγ agonist alone do not provide adequate glycemic control; as triple oral therapy in combination w/ sulfonylurea & metformin when diet & exercise + dual therapy w/ these medicinal products do not provide adequate glycemic control or w/ PPARγ agonist & metformin when use of PPARγ agonist is appropriate & when diet & exercise + dual therapy w/ these medicinal products do not provide adequate glycemic control. As add-on to insulin (w/ or w/o metformin) when diet & exercise + stable dose of insulin do not provide adequate glycemic control.

100 mg once daily. Patient w/ moderate renal impairment (eGFR ≥30 mL/min/1.73 m²) 50 mg once daily. Patient w/ severe renal impairment (eGFR <30 mL/min/1.73 m²) or ESRD requiring hemodialysis or peritoneal dialysis 25 mg once daily. May be administered w/o regards to the timing of dialysis.

May be taken with or without food.

Hypersensitivity.

Do not use in patients w/ type 1 diabetes or for treatment of diabetic ketoacidosis. Risk of developing acute pancreatitis; discontinue therapy if pancreatitis is suspected & do not restart if acute pancreatitis is confirmed. History of pancreatitis. Hypoglycemia. Patients at risk for heart failure (eg, history of heart failure). Severe & disabling arthralgia. Discontinue if bullous pemphigoid is suspected. Moderate & severe renal impairment, ESRD patients requiring hemodialysis or peritoneal dialysis. Pregnancy. Not to be used during lactation.

Hypoglycemia; headache.

Altered pharmacokinetics w/ potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, clarithromycin) in patients w/ severe renal impairment or ESRD. Increased AUC & C_max w/ ciclosporin. Increased plasma AUC of digoxin.

Antidiabetic Agents

A10BH01 - sitagliptin ; Belongs to the class of dipeptidyl peptidase 4 (DPP-4) inhibitors. Used in the treatment of diabetes.

Rx