Adivia

Adivia Overdosage

sitagliptin

Manufacturer:

Lloyd

Distributor:

InnoGen Pharmaceuticals
Full Prescribing Info
Overdosage
During controlled clinical trials in healthy subjects, single doses of up to 800 mg Sitagliptin were generally well tolerated. Minimal increase in QTc, not considered to be clinically relevant, were observed in one study at a dose of 800 mg Sitagliptin. There is no experience with doses above 800 mg in clinical studies. In Phase I multiple-dose studies, there were no dose-related clinical adverse reactions observed with Sitagliptin with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for periods of up to 28 days.
In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required.
Sitagliptin is moderately dialyzable, in clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session.
Prolonged hemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialyzable by peritoneal dialysis.
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