Torsit 50/Torsit 100

Type 2 DM in adults to improve glycemic control: Monotherapy in patients inadequately controlled by diet & exercise alone & for whom metformin is inappropriate due to contraindications or intolerance. Dual oral therapy in combination w/ metformin when diet & exercise + metformin alone do not provide adequate glycemic control; w/ sulphonylurea when diet & exercise + maximal tolerated dose of sulphonylurea alone do not provide adequate glycemic control & when metformin is inappropriate due to contraindications or intolerance; w/ peroxisome proliferator-activated receptor γ (PPAR) agonist (ie, thiazolidinedione) when use of PPAR agonist is appropriate & when diet & exercise + PPAR agonist alone do not provide adequate glycemic control. Triple oral therapy in combination w/ sulphonylurea & metformin when diet & exercise + dual therapy w/ these medicinal products do not provide adequate glycemic control; w/ PPARγ agonist & metformin when use of PPAR agonist is appropriate & when diet & exercise + dual therapy w/ these medicinal products do not provide adequate glycemic control. 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 (CrCl ≥30-<50 mL/min) 50 mg once daily. Patient w/ severe renal impairment (CrCl <30 mL/min) or ESRD requiring hemodialysis or peritoneal dialysis 25 mg once daily, may be administered w/o regard to timing of dialysis.

May be taken with or without food.

Hypersensitivity.

Not to be used in patients w/ type 1 diabetes or for treatment of diabetic ketoacidosis. Discontinue treatment & other potentially suspect medicinal products if pancreatitis is suspected. Do not restart treatment if acute pancreatitis is confirmed. Discontinue use if hypersensitivity reaction is suspected. Caution in patients w/ history of pancreatitis. Hypoglycemia has been observed when used in combination w/ insulin or sulphonylurea. Assess renal function prior to treatment initiation & periodically thereafter. Lower dosages in patients w/ moderate & severe renal impairment, & in ESRD patients requiring hemodialysis or peritoneal dialysis. Reports of dizziness & somnolence; exercise caution when driving or operating machinery. Not to be used during pregnancy & lactation. Safety & efficacy have not been established in childn & adolescents <18 yr.

Pancreatitis, hypersensitivity reactions. Hypoglycemia (in combination w/ sulphonylurea & insulin).

Potent CYP3A4 inhibitors (ie, ketoconazole, itraconazole, ritonavir, clarithromycin) could alter sitagliptin pharmacokinetics in patients w/ severe renal impairment or ESRD. Increased plasma AUC & Cmax of digoxin. May be a mild inhibitor of P-gp in vivo.

Antidiabetic Agents

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

Rx