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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:
1. Absorption and excretion study
Drugs used: S-6437 and a preparation (E-CEX) consisting of only enteric coated granules of cephalexin (as a control preparation).
Dose given: Single dose of 25mg/kg, which was orally administered 30 minutes after breakfast.
2. Clinical study in pediatric patients with urinary tract infections (UTI)
Drug used: S-6437.
Dose and administration: 52mg/kg/day (average) in two divided doses (given 30 minutes after breakfast and dinner).
Number of subject: 22 pediatric patients with UTI.
The results of the above two studies are as follows:
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.
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.
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.
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.
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.
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.
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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In order to evaluate efficacy and safety of sustained release cephalexin (S-6437), comparative double blind studies with regular cephalexin (CEX) were conducted is pediatric patients with acute pharyngitis and tonsillitis. The patients were given S-6437 or CEX within 24 hours after fever appeared. The daily dose used was 500mg of cephalexirt in both drugs. S-6437 was administered at two divided doses per day and CEX was given at four divided doses per day.
The following is the summary of the results of the studies. From the studies, it was judged that S-6437 had usefulness.
1. There were no significant differences between both groups (S-6437 treated, group and CEX treated group) regarding background of the patients. Uniformity of both groups was kept and both groups did not have any background factors having effects on clinical effectiveness of the drugs.
2. Clinical effectiveness of S-6437 and CEX was 91.8% and 86.8% respectively. No significant difference was observed. However, the results of the studies in the patients who visited hospitals within 6 hours after fever appeared and who visited hospitals at night showed that S-6437 was significantly (P<0.05) superior to CEX. Also, in patients from whom Staph. aureus was isolated as a causative organism, S-6437 tended to be superior to CEX, though no significant (P<0.10) difference was found.
3. Looking into the results of the studies by visiting time of the patients to hospitals, in the patients visiting hospitals. at night, S-6437 was significantly (P<f0.05) superior to CEX as to antipyretic time, but in the patients visiting at daytime, there was no significant difference between both groups. The difference of the antipyretic time between S-6437 and CEX in the patients visiting hospitals at night was considered to be due to the fact that their administration interval at night in the first treatment day was longer than that in next day.
4. Subjective and objective symptoms (e. g. body temperature, sore throat, pain in swallowing, bad humor, reddened throat, swelling) and amount of intake were examined after the administration of the drugs, and no significant differences were observed between both groups.
5. Slight diarrhea and abdominal pain were observed in only one patient receiving CEX but there were no significant differences in side effects between both groups.

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1. Ten patients with chronic urinary tract infection by Pseudomonas aeruginosa or Proteus species were treated with carfecillin. Excellent response was seen in one case, fairly good in 5 cases and clinical effective rate was 60%.
2. The recurrence suppression effect of carfecillin was examined in two patients suffering from complicated urinary tract infection. In both cases, recurrence was not found when carfecillin was administered for a week after the effective pretreatment of carbenicillin, but found when administered for two weeks.
3. Side effects were observed in 3 cases (itching, tinnitus, diarrhea).

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[in Japanese]

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[in Japanese]

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[in Japanese]

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[in Japanese]

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[in Japanese]

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