ABSORPTION, EXCRETION AND CLINICAL TRIALS OF CEFROXADINE IN THE FIELD OF PEDIATRICS

Abstract

A study was made with the newly developed cefroxadine (CXD) dry syrup by measuring the serum level, urine excretion and recovery rate in10child ren who were orally administered 5, l0and 20mg/kg at 1hour after meals and the following results were gained. Also, its clinical efncacies and side efrects were investigated in the following cases who were treated with amean dose of 33mg/day divided into3to4portions for a period ofg days on the average; viz. a total of 151cases consiting of 9 cases of pharyngitis, 39of tonsillitis, 11of streptococcal infection, i.e. scarlet fever, 7 of bronchitis, 6 of pneumonia, 1of otitis media, 6 of purulent Iymphadenitis, 1of purulent parotitis, 1 of subcutaneous abscess and3of impetigo.
1. The serum level tends to reach its maximum level within 1hour after administration. The mean concentrations of5, 10and20mg/kgdose in the foregoing time were6. 35, 9. 12 and 21. 62 mcg/ml respectively and dose response was observed. CXD showed higher concentration than CEX, CED and CFT. The mean half-1ife periods of the 3 dose were 72, 84 and 66 minutes respectively and variations were observed, but the drugs maintains a satisfactory serum level.
2. The time which showed highest urine excretion was mainly in the 0to2hours bracket and th eaverage concentrations of5, 10and20mg/kg dose in the foregoing time were381. 2,771. 7 and 1,577. 7mcg/ml respectively. The dose response was more evident than in the serum concentrations. The average recovery rates within6hours were93. 6, 88. 3and94. 3%respectively and they were similar to those of CEX, CED and CFT.
3. The clinical effects were evaluated were in148cases out of the total of151and136cases, or 91.9%showed good or excellent efficacy response.
4. The daily dose groups of less than30mg/kg and31to40mg/kg formed the majority and there was no difference in the comparison of the clinical effectiveness in these2groups. Administration of a daily dose of20to40mg/kg is sufficient for the treatment of the aforementioned mild diseases except for pneumonia.
5. The clinical effects were compared between the3and4times a day treatment groups, but there was no difference between these two groups with regard to the foregoing daily dose. The3times a day treatment is acceptable, but the4times a day treatment is preferable when pharmacokinetics is taken into account.
6. The bacteriological effects in41cases, or97. 6%out of the42cases were above the efficacy base line and a high efficacy rate was achieved.
7. With regard to side effects, diarrhea developed in4cases and eosinophilia in6cases, abnormal simultaneous increases in GOT and GPT in1case and1case each for abnormal values in LDH and BUN were seen in the clinical test values.
The foregoing results show that CXD has high efficacy and safety and it can be said that it is adrug required in the pediatric field.