Sitagliptin Sandoz Dosage/Direction for Use

Posology: The recommended dose is 100 mg sitagliptin once daily as monotherapy or as combination therapy with metformin, a sulfonylurea, insulin (with or without insulin), a PPARγ agonist (e.g. thiazolidinediones), metformin plus a sulfonylurea, or metformin plus a PPARγ agonist.
Sitagliptin can be taken with or without food.
When sitagliptin is used in combination with a sulphonylurea or with insulin, a lower dose of sulphonylurea or insulin may be considered to reduce the risk of sulphonylurea- or insulin-induced 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 (estimated glomerular filtration rate [GFR] ≥60 mL/min/1.73 m² to <90 mL/min/1.73 m²), no dose adjustment is required.
For patients with moderate renal impairment (GFR ≥45 mL/min/1.73 m² to <60 mL/min/1.73 m²), no dosage adjustment is required.
For patients with moderate renal impairment (GFR ≥30 mL/min/1.73 m² to <45 mL/min/1.73 m²), the dose of sitagliptin is 50 mg once daily.
For patients with severe renal impairment (GFR ≥15 mL/min/1.73 m² to <30 mL/min/1.73 m²) or with end-stage renal disease (ESRD) (GFR <15 mL/min/1.73 m²), 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 (Child-Pugh score 7 to 9).
Sitagliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score >9) 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.
Paediatric population: Sitagliptin should not be used in children and adolescents 10 to 17 years of age because of insufficient efficacy. Currently available data are described in Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions. Sitagliptin has not been studied in paediatric patients under 10 years of age.