Gliptadin

Sitagliptin phosphate monohydrate

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. Moderate renal impairment (CrCl ≤30 to <50 mL/min) 50 mg once daily. Severe renal impairment (CrCl <30 mL/min) or ESRD requiring hemodialysis or peritoneal dialysis 25 mg once daily.

May be taken with or without food.

Hypersensitivity.

Not to be used in patients w/ type 1 diabetes or for diabetic ketoacidosis. Discontinue use if pancreatitis, bullous pemphigoid or hypersensitivity reaction is suspected. Risk of developing acute pancreatitis. Patients w/ history of pancreatitis. Hypoglycemia in combination w/ other anti-hyperglycemic medicinal products. Assess renal function prior to initiation of treatment & periodically thereafter. May affect ability to drive & use machines. Severe hepatic impairment. Not to be used during pregnancy & lactation. Childn & adolescents <18 yr.

Hypoglycemia; headache.

Pharmacokinetics could be altered in patients w/ severe renal impairment or ESRD w/ potent CYP3A4 inhibitors ie, ketoconazole, itraconazole, ritonavir, clarithromycin. Increased plasma AUC of digoxin. Enhanced effects w/ ofloxacin. Potential hyperglycemia or hypoglycemia 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