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Bergliptin

Bergliptin Dosage/Direction for Use

sitagliptin

Manufacturer:

Berlin Pharm

Marketer:

Berlin Pharm
Full Prescribing Info
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 Bergliptin administered concomitantly.
When Bergliptin is 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 Bergliptin 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 Bergliptin 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 Bergliptin 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 Bergliptin and periodically thereafter.
Hepatic impairment: No dose adjustment is necessary for patients with mild to moderate hepatic impairment. Bergliptin 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: Bergliptin can be taken with or without food.
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