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GLIPTADIN/FC TAB/100 MG/BOX OF 30S
Place of Origin
The dose is 100 mg sitagliptin once daily. When used in combination with metformin and/or a PPAR? agonist, the dose of metformin and/or PPAR? agonist should be maintained, and sitagliptin tablets administered concomitantly.
When sitagliptin tablet 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.
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.
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 (creatinine clearance [CrCl] > 50 mL/min), no dose adjustment is required.
For patients with moderate renal impairment (CrCl < 30 to < 50 mL/min), the dose of sitagliptin tablets is 50 mg once daily.
For patients with severe renal impairment (CrCl <30 mL/min) or with end-stage renal disease (ESRD) requiring hemodialysis 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.
No dose adjustment is necessary for patients with mild to moderate hepatic impairment.
Sitagliptin tablets 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.
No dose adjustment is necessary based on age.
The safety and efficacy of sitagliptin in children and adolescents under 18 years of age have not yet been established. No data are available.
Method of administration
Sitagliptin can be taken orally with or without food.
Sitagliptin Phosphate Monohydrate, USP