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 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 (glomerular filtration rate [GFR] ≥60 mL/min to 90 mL/min,), no dosage adjustment for JANUVIA is required.
For patients with moderate renal impairment (GFR ≥45 mL/min to <60 mL/min), no dosage adjustment for JANUVIA is required.
For patients with moderate renal impairment (GFR ≥30 mL/min to <45 mL/min), the dose of JANUVIA is 50 mg once daily.
For patients with severe renal impairment (GFR ≥15 mL/min to <30 mL/min,) or with end-stage renal disease (ESRD) (GFR <15 mL/min), 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.
Patients with Hepatic Impairment: In patients with moderate hepatic insufficiency (Child-Pugh score 7 to 9), mean AUC and C_max of sitagliptin increased approximately 21% and 13%, respectively, compared to healthy matched controls following administration of a single 100-mg dose of JANUVIA. These differences are not considered to be clinically meaningful. No dosage adjustment for JANUVIA is necessary for patients with mild to moderate hepatic impairment. JANUVIA has not been studied in patients with severe hepatic impairment (Child-Pugh score >9).