Xigatin Dosage/Direction for Use

Posoloqv (adults): The recommended dose of Xigatin TM is 100 mg once daily as monotherapy or as combination therapy with metformin, a sulfonylurea, insulin (with or without metformin), a PPARy agonist (i.e., thiazolidinediones), metformin plus a sulfonylurea, or metformin plus a PPARy agonist. Xigatin can be taken with or without food.
When Xigatin 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 Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products 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 Xigatin 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 Xigatin 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 Xigatin 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 Xigatin 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 Xigatin is 25 mg once daily. Xigatin may be administered without regard to the timing of dialysis.
Pediatric population: Xigatin should not be used in children and adolescents 10 to 17 years of age because of insufficient efficacy. Xigatin has not been studied in pediatric patients under 10 years of age.
Route of Administration: Oral administration.
The tablet should be swallowed whole with sufficient liquid and can be taken with or without food.