Generic Name and Formulations:
Sitagliptin (as phosphate) 25mg, 50mg, 100mg; tabs.
Merck & Co., Inc.
Indications for JANUVIA:
Adjunct to diet and exercise in type 2 diabetes, as monotherapy or combination therapy.
Limitations Of use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis. Not studied in patients with history of pancreatitis.
100mg once daily. Renal insufficiency: CrCl ≥30–50mL/min: 50mg once daily; CrCl<30mL/min or on dialysis: 25mg once daily.
<18yrs: not established.
Assess renal function before starting therapy and periodically thereafter. Consider risks/benefits in patients with known risk factors for heart failure; monitor for signs/symptoms; evaluate and consider discontinuing if develops. Monitor for signs/symptoms of pancreatitis, serious hypersensitivity reactions, severe joint pain, or bullous pemphigoid; discontinue if suspected or occurs. History of angioedema to other DPP-4 inhibitors. Severe hepatic insufficiency. Elderly. Pregnancy (Cat.B). Nursing mothers.
May need lower dose of concomitant sulfonylurea or insulin to reduce risk of hypoglycemia. Monitor digoxin.
Dipeptidyl peptidase-4 (DPP-4) inhibitor.
Upper respiratory tract infection, nasopharyngitis, headache; pancreatitis, heart failure, hypersensitivity reactions (eg, anaphylaxis, angioedema, Stevens-Johnson syndrome), severe and disabling arthralgia, bullous pemphigoid.
Tabs 25mg, 50mg—30, 90, 100; 100mg—30, 90, 100, 1000