Glyxera Dosage/Direction for Use

Method of administration: For oral use. Sitagliptin (Glyxera) can be taken with or without food. Or as prescribed by the physician.
Posology: 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 sulfonylurea or with insulin, a lower dose of the sulfonylurea or insulin may be considered to reduce the risk of hypoglycemia (see Precautions).
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.
Special populations: Renal impairment: When considering the use of sitagliptin in combination with another anti-diabetic medicinal product, its conditions for use in patients with renal impairment should be checked.
For patients with mild renal impairment (GFR ≥60 to <90 mL/min), no dose adjustment is required.
For patients with moderate renal impairment (GFR ≥45 to <60 mL/min), no dosage adjustment is required.
For patients with moderate renal impairment (GFR ≥30 to <45 mL/min), the dose of Sitagliptin is 50 mg once daily.
For patients with severe renal impairment (GFR ≥15 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 Sitagliptin is 25 mg once daily. Treatment may be administered without regard to the timing of dialysis.
Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended 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 (see Pharmacology: Pharmacokinetics under Actions).
However, because sitagliptin is primarily renally eliminated, severe hepatic impairment is not expected to affect the pharmacokinetics of sitagliptin.
Elderly: No dose adjustment is necessary based on age.
Pediatric population: The safety and efficacy of sitagliptin in children and adolescents under 18 years of age have not yet been established. No data are available.