Januvia Dosage/Direction for Use

The recommended dose of JANUVIA is 100 mg once daily as monotherapy or as combination therapy with metformin, a sulfonylurea, insulin (with or without metformin), a PPARγ agonist (e.g., thiazolidinediones), metformin plus a sulfonylurea, or metformin plus a PPARγ agonist. JANUVIA can be taken with or without food.
When JANUVIA is used in combination with a sulfonylurea or with insulin, a lower dose of sulfonylurea or insulin may be considered to reduce the risk of sulfonylurea- or insulin-induced hypoglycemia. (See Hypoglycemia in Combination with a Sulfonylurea or with Insulin under PRECAUTIONS.)
Patients with Renal Impairment: Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of JANUVIA and periodically thereafter.
For patients with mild renal impairment (estimated glomerular filtration rate [eGFR] ≥ 60 mL/min/1.73 m² to < 90 mL/min/1.73 m²), no dosage adjustment for JANUVIA is required.
For patients with moderate renal impairment (eGFR ≥45 mL/min/1.73 m² to < 60 mL/min/1.73 m²), no dosage adjustment for JANUVIA is required.
For patients with moderate renal impairment (eGFR ≥30 mL/min/1.73 m² to < 45 mL/min/1.73 m²), the dose of JANUVIA is 50 mg once daily.
For patients with severe renal impairment (eGFR ≥15 mL/min/1.73 m² to < 30 mL/min/1.73 m²) or with end-stage renal disease (ESRD) (eGFR < 15 mL/min/1.73 m²), including those requiring hemodialysis or peritoneal dialysis, the dose of JANUVIA is 25 mg once daily. JANUVIA may be administered without regard to the timing of dialysis.