Vilantra

Sitagliptin phosphate

Improve glycaemic 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 glycaemic control, w/ sulfonylurea when diet & exercise + max tolerated dose of sulfonylurea alone do not provide adequate glycaemic 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 glycaemic control; as triple oral therapy in combination w/ sulfonylurea & metformin when diet & exercise + dual therapy w/ these medicinal products do not provide adequate glycaemic 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 glycaemic control. As add-on to insulin (w/ or w/o metformin) when diet & exercise + stable dose of insulin do not provide adequate glycaemic control.

100 mg once daily. Patient w/ moderate renal impairment (CrCl ≥30-<50 mL/min) 50 mg once daily, severe renal impairment (CrCl <30 mL/min) or w/ ESRD requiring haemodialysis or peritoneal dialysis 25 mg once daily.

May be taken with or without food.

Hypersensitivity.

Serious hypersensitivity reactions including anaphylaxis, angioedema & exfoliative skin conditions including SJS); discontinue if hypersensitivity reactions is suspected. Not to be used in patients w/ type 1 diabetes or treatment of diabetic ketoacidosis. Risk of developing acute pancreatitis; discontinue use if acute pancreatitis is suspected. History of pancreatitis. Risk of hypoglycaemia when used in combinations w/ other anti-hyperglycaemic medicinal product; consider lower dose of sulphonylurea or insulin. Moderate & severe renal impairment & ESRD patients requiring haemodialysis or peritoneal dialysis. Not to be used during pregnancy & lactation. Childn & adolescents <18 yr.

Potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, clarithromycin) can alter the pharmacokinetics in patients w/ severe renal impairment or ESRD. May increase 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