Experimental and clinical studies on a sustained preparation of amoxicillin (C-AMOX) in the fields of internal medicine

Abstract

C-AMOX, a newly developed oral antibacterial agent, was evaluated experimentally and clinically for 178 patients with various infection, and results were as follows.Absorption and excretionMean serum concentration of C-AMOX reached to the peak level of 7.3 μg/ml, 3.3, μg/ml at four and six hours respectively after an oral administration of 500 mg to 6 healthy male volunteers. They decreased to 1.2, μg/ml and 0.24, μg/ml at ten hours after respectively.Mean urinary recovery rates were 69.1% and 63.4% respectively. In continuous administration of 500 mg and 1000 mg for 5 days at fasting, C-AMOX showed dose response and no cumulative tendency.Clinical evaluation1) C-AMOX was given orally to 500 mg (b.i.d.) to 178 cases, 109 cases with respiratory tract infection, 59 cases with urinary tract infection and 10 cases with enteritis. The clinical effects were excellent in 26 cases, good in 108 cases fair in 24 cases, and poor in 20 cases. Total clinical effectiveness rate of 75.3% was obtained.2) Bacteriological examination was carried out in 80 cases. The eliminative rate in gram positives was 85.7%, in gram negative 64.8% and in mixed isolates 58.3% respectively.3) Side effects were observed in each of one case of urticaria, nausea and soft stool, and three cases of stomach discomfort. Medication was continued except one case of nausea. In the laboratory findings, decrease of WBC count, increase of eosimocyte count, elevation of GOT value, elevation of GOT, GPT values, elevation of GPT, AL-P values, and increase of BUN, creatinine values in serum were observed in one case respectively.