JANUVIA 100MG TABLET (TABLET)

Dosage / Direction for Use Monotherapy or combination therapy w/ metformin, sulfonylurea, insulin (w/ or w/o metformin), PPARγ agonist, metformin plus sulfonylurea or metformin plus PPARγ agonist 100 mg once daily. Patients w/ renal impairment Mild renal impairment (eGFR ≥60 to <90 mL/min/1.73 m2) to moderate renal impairment (eGRF ≥45 to <60 mL/min/1.73 m2): No dosage adjustment is required. Moderate renal impairment (eGFR ≥30 to <45 mL/min/1.73 m2): 50 mg once daily. Severe renal impairment (eGFR ≥15 to <30 mL/min/1.73 m2) or end-stage renal disease (ESRD) (eGFR <15 mL/min/1.73 m2) requiring hemodialysis or peritoneal dialysis: 25 mg once daily. May be administered w/o regards to the timing of dialysis. Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Januvia & periodically thereafter. Administration May be taken with or without food. Contraindications Type 1 DM, diabetic ketoacidosis. Special Precautions Patients w/ renal impairment. To achieve plasma conc of sitagliptin phosphate similar to those patients w/ normal renal function, lower dosages are recommended in patients w/ eGFR <45 mL/min/1.73 m2, as well as in ESRD patients requiring hemodialysis or peritoneal dialysis. Lower dose of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia. Patients should be informed of the characteristic symptom of acute pancreatitis: Persistent, severe abdominal pain. Hypersensitivity reactions. Discontinue if pancreatitis or hypersensitivity reaction is suspected. Pregnancy & lactation. Elderly. Childn <18 yr. Side Effects / Adverse Reactions Hypoglycemia (based on all reports of symptomatic hypoglycemia, concurrent glucose measurement was not required); abdominal pain, nausea, vomiting, diarrhea, dyspepsia, flatulence; hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis & exfoliative skin conditions including Stevens-Johnson syndrome; influenza, headache, acute pancreatitis including fatal & nonfatal hemorrhagic & necrotizing pancreatitis, worsening renal function, upper resp tract infection, fungal skin infection, peripheral edema, nasopharyngitis, constipation, arthralgia, myalgia, pain in extremity, back pain, pruritus, pemphigoid. Interactions Digoxin, cyclosporine.