ABSORPTION AND EXCRETION, AND CLINICAL STUDY OF SUSTAINED RELEASE CEPHALEXIN (S-6437) IN CHILDREN

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  • 持続性Cephalexin (S-6437) 顆粒の小児における吸収・排泄および臨床成績
  • ジゾクセイ Cephalexin S- 6437 カリュウ ノ ショウニ ニ

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Abstract

In order to evaluate absorption and excretion, and clinical efficacy of S-6437 (a preparation consisting of enteric coated granules and nonenteric coated ones of cephalexin), the following two studies were conducted:<BR>1. Absorption and excretion study<BR>Drugs used: S-6437 and a preparation (E-CEX) consisting of only enteric coated granules of cephalexin (as a control preparation).<BR>Dose given: Single dose of 25mg/kg, which was orally administered 30 minutes after breakfast.<BR>2. Clinical study in pediatric patients with urinary tract infections (UTI)<BR>Drug used: S-6437.<BR>Dose and administration: 52mg/kg/day (average) in two divided doses (given 30 minutes after breakfast and dinner).<BR>Number of subject: 22 pediatric patients with UTI.<BR>The results of the above two studies are as follows:<BR>1. The blood levels with the administration of S-6437 and E-CEX were as high as those with regular cephalexin (R-CEX) but were maintained longer than those with R-CEX. Comparing the absorption of S-6437 and E-CEX, S-6437 was better than E-CEX.<BR>2. Excretion of both preparations (S-6437 and E-CEX) in urine was observed until at least 12 hours after the administrations. Therefore, it is expected that these preparations are effective in urinary tract infections.<BR>3. However, urinary recovery of these preparations (S-6437 and E-CEX) in this study was lower as compared to the data which have been reported before. The reason for this is considered to be that the urine volume of the children was little.<BR>4. Effectivenes of S-6437 in 22 pediatric patients with UTI was as follows: 79% in clinical response, 95% in bacteriological test and 96% in total effectiveness.<BR>5. Out of 16 strains of E. coli isolated from the patients, the MIC of the 14 strains against cephalexin ranged from 6.25 to 25mcg/ml in both inoculum sizes of 108 and 106 cells/ml. In 106 cells/ml of inoculum size, however, the strains showed the trend of increasing their susceptibility against cephalexin.<Br>6. As side effects, peripheral eosinophilia was observed in only one patient. However, no any other side effects were found. No abnormalities in GOT, GPT, ALP, LDH, BUN, and creatinine were observed.<BR>From the above results, it is expected that S-6437 has much effectiveness and safety as R-CEX. Also, it has an advantage that the frequence of the administration of S-6437 is less than that of R-CEX. Therefore, it is desired that S-6437 becomes available in pediatric field as soon as possible.

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