2002 Volume 50 Issue 10 Pages 640-645
A new penem oral antibacterial agent, faropenem sodium, was orally administered to 17 elderly hospitalized patients, whose ages averaged 78.4 years, with a confirmed infection at a dose of one tablet (150 mg) 3 times a day for 4-8 consecutive days, as part of a postmarketing clinical trial. Changes in blood concentration and its safety were studied and the following results below obtained.
1. Pharmacokinetic parameters
Pharmacokinetic parameters in elderly patients were Cmax 1.09±0.43, μg/mL, Tmax2.29±1.16h, T1/22.42± 3.09h and AUC0-24 5.03±2.57, μg·h/mL. Compared to healthy adult volunteers, a low Cmax and extended Tmax and T, 2 were found together with a trend toward slightly increased AUC0-24.
2. Safety
Only 1 of the 17 patients experienced any side effects, symptoms of slight diarrhea. Slight abnormalities in laboratory test results with a possible positive relationship to this drug included elevated GOT and GPT in 1 patient and elevated GOT, GPT, ALP, and BUN in another. These changes were minimal in both cases.
