RiteMED Sitagliptin

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/ sulfonylurea when diet & exercise + maximal tolerated dose of sulfonylurea alone do not provide adequate glycemic control & when metformin is inappropriate due to contraindications or intolerance; 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. Triple oral therapy in combination w/ sulfonylurea & metformin when diet & exercise + dual therapy w/ these medicinal products do not provide adequate glycemic control; 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. 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 or bullous pemphigoid is suspected. Caution in patients w/ history of pancreatitis. Hypoglycemia has been observed when used in combination w/ insulin or sulfonylurea. 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. Occasional reports of somnolence, impairment of skills, dizziness & visual disturbances; 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.

Hypoglycemia; headache.

Potent CYP3A4 inhibitors (ie, ketoconazole, itraconazole, ritonavir, clarithromycin) could alter sitagliptin pharmacokinetics in patients w/ severe renal impairment or ESRD. Increased plasma AUC & C_max of digoxin. May be a mild inhibitor of P-gp in vivo. Enhanced effects by pharmacodynamic synergism w/ ofloxacin. May result in hyperglycemia or hypoglycemia causing somnolence, dizziness & visual disturbances w/ quinolone antibiotic.

Antidiabetic Agents

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

Rx