Sitazuca Dosage/Direction for Use

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 Tablets are used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see Precautions).
If a dose of Sitagliptin Tablet 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 (glomerular filtration rate [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 Tablet 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 haemodialysis or peritoneal dialysis, the dose of Sitagliptin Tablet 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 Tablets and periodically thereafter.
Hepatic impairment: No dose adjustment is necessary for patients with mild to moderate hepatic impairment. Sitagliptin Tablet 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.
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.
Method of administration: Sitagliptin Tablets can be taken with or without food.