Xiglip Dosage/Direction for Use

The dose is 100 mg sitagliptin once daily. When used in combination with metformin and/or a PPARγ agonist, the dose of metformin and/or PPARγ agonist should be maintained, and sitagliptin administered concomitantly.
When sitagliptin is used in combination with a sulphonylureas or with insulin, a lower dose of the sulphonylureas or insulin may be considered to reduce the risk of hypoglycemia. If a dose of sitagliptin is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.
Recommended Dose for Specific Population: Renal Impairment: Patients with an estimated glomerular filtration rate [eGFR] greater than or equal to 45 mL/min/1.73 m² to less than 90 mL/min/1.73 m², no dosage adjustment for Sitagliptin is required.
Patients with moderate renal impairment (eGFR greater than or equal to 30 mL/min/1.73 m² to less than 45 ml/min/1.73 m²), the dose of sitagliptin is 50 mg once daily.
Patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m²) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of sitagliptin is 25 mg once daily.
Sitagliptin may be administered without regard to the timing of dialysis. Assess renal function prior to initiation of sitagliptin and periodically thereafter.
Hepatic Impairment: No dose adjustment is necessary for patients with mild to moderate hepatic impairment. Sitagliptin has not been studied in patients with severe hepatic impairment and care should be exercised. However, because sitagliptin is primarily renally eliminated, severe hepatic impairment is not expected to affect the pharmacokinetics of sitagliptin.
Geriatrics: In pre-approval clinical safety and efficacy studies of sitagliptin, 725 patients were 65 years and over, while 61 patients were 75 years and over. No overall differences in safety or effectiveness were observed between subjects 65 years and over and younger subjects. While this and other reported clinical experience have not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out. Sitagliptin is substantially excreted by the kidney. Aging can be associated with reduced renal function, therefore, elderly patients should be assessed and monitored more frequently.
Pediatric Population: The safety and efficacy of sitagliptin in children and adolescents under 18 years of age have not yet been established.
Method of Administration: Sitagliptin can be taken with or without food.
Oral route.