New Study Data: JANUVIA™ (sitagliptin) Significantly Reduced Blood Sugar Levels and Was Not Associated with Hypoglycemia in Elderly Patients with Type 2...(n safety or effectiveness were observed ...),Health

Date:11/21/2008

n safety or effectiveness were observed between subjects 65 years and over and younger subjects. While this and other reported clinical experience have not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.
This drug is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly, and it may be useful to assess renal function in these patients prior to initiating dosing and periodically thereafter [see Dosage and Administration (2.2); Clinical Pharmacology (12.3).

• OVERDOSAGE

During controlled clinical trials in healthy subjects, single doses of up to 800mg JANUVIA were administered. Maximal mean increases in QTc of 8.0msec were observed in one study at a dose of 800mg JANUVIA, a mean effect that is not considered clinically important [see Clinical Pharmacology (12.2). There is no experience with doses above 800mg in humans. In PhaseI multiple-dose studies, there were no dose-related clinical adverse reactions observed with JANUVIA with doses of up to 600 mg per day for periods of up to 10 days and 400mg per day for up to 28 days.

• 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 as dictated by the patient's clinical status.

Sitagliptin is modestly dialyzable. In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session. Prolo
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