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 (i.e., 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 hypoglycaemia. (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.
Pediatric population: JANUVIA should not be used in children and adolescents 10 to 17 years of age because of insufficient efficacy. JANUVIA has not been studied in pediatric patients under 10 years of age.