Fortesia Dosage/Direction for Use

The recommended dose for Fortesia Tablet is 100 mg once daily as monotherapy or as combination therapy with metformin, a sulfonylurea, insulin (with or without metformin), PPARy agonist (i.e thiazolidinediones) metformin plus a sulfonylurea or metformin plus a PPARy agonist Fortesia Tablet can be taken with or without food.
When Fortesia Tablet 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 Hypoglycaemia in Combination with 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 Fortesia 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 Fortesia 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 Fortesia 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 Fortesia 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/1.73m²), including those requiring hemodialysis or peritoneal dialysis, the dose of Fortesia is 25 mg once daily. Fortesia may be administered without regard to the timing of dialysis.
Pediatric population: Fortesia should not be used in children and adolescents 10 to 17 years of age because of insufficient efficacy. Fortesia has not been studied in pediatric patients under 10 years of age.
Route of Administration: Oral.