Jimandin

Monotherapy as an adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM. In combination w/ metformin as initial therapy or when the single agent alone, w/ diet & exercise does not provide adequate glycemic control in patients w/ type 2 DM. In combination w/ sulfonylurea & PPARγ agonist (eg, thiazolidinediones) when the single agent alone; or dual therapy w/ metformin & sulfonylurea, w/ diet & exercise do not provide adequate glycemic control in patients w/ type 2 DM. Add-on to insulin (w/ or w/o metformin) when diet & exercise plus stable insulin dose do not provide adequate glycemic control.

100 mg once daily. Moderate renal impairment (eGFR ≥30 mL/min/1.73 m² to <45 mL/min/1.73 m²) 50 mg once daily. Severe renal impairment (eGFR ≥15 mL/min/1.73 m² to <30 mL/min/1.73 m²) or ESRD (eGFR <15 mL/min/1.73 m²) including those requiring hemodialysis or peritoneal dialysis 25 mg once daily. May be administered w/o regard to the timing of dialysis. Concomitant use w/ insulin secretagogue (eg, sulfonylurea) or insulin Lower dose of insulin secretagogue (eg, sulfonylurea) or insulin may be required to reduce risk of hypoglycemia.

May be taken with or without food.

History of serious hypersensitivity reaction (eg, anaphylaxis or angioedema).

Discontinue use if hypersensitivity reaction (eg, anaphylaxis, angioedema & exfoliative skin conditions including SJS) is suspected, assess for other potential causes & initiate alternative diabetes treatment. Not to be used in patients w/ type 1 diabetes or for diabetic ketoacidosis. Reported acute pancreatitis, including fatal & non-fatal hemorrhagic or necrotizing pancreatitis; promptly discontinue use & initiate appropriate management if pancreatitis is suspected. Hypoglycemia has been observed when used in combination w/ insulin or a sulfonylurea. Bullous pemphigoid; instruct patients to report development of blisters or erosions while receiving sitagliptin. Discontinue use if bullous pemphigoid is suspected; consider referral to a dermatologist for diagnosis & appropriate treatment. Severe & disabling arthralgia; consider DDP-4 inhibitors as possible cause for severe joint pain & discontinue use if appropriate. May impair the ability to drive & use machines due to possible dizziness & somnolence. Patients w/ eGFR <45 mL/min/1.73 m² & those w/ ESRD requiring hemodialysis or peritoneal dialysis. Pregnancy & lactation. Not to be used in childn & adolescents 10-17 yr. Childn <10 yr. Elderly; assess renal function prior to initiating dosing & periodically thereafter.

Hypoglycemia; GI adverse reactions (eg, abdominal pain, nausea, diarrhea); nasopharyngitis; URTI, headache.

Slightly increased AUC & C_max of digoxin.

Antidiabetic Agents

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

POM