cefpodoxime-proxetil and Abscess

Patients with skin and soft tissue infections were enrolled in a study comparing 2 dosage regimens of orally administered cefpodoxime proxetil; 204 patients with mild to moderate infections received cefpodoxime proxetil 200mg twice daily and 47 patients with severe infections received 400mg twice daily. Both dosage regimens were given for 7 to 14 days. 132 of 142 (93.0%) evaluable patients in the 200mg group and 22 of 29 (75.9%) in the 400mg group were clinically cured post-therapy, the remainder in both groups being classified as improved. The pathogen eradication rate at the end of therapy in the 200mg group was 161 of 165 (97.6%), and 38 of 38 (100%) in the 400mg group. Adverse reactions (drug-related) were reported by 20 (8.0%) patients overall, and there was no apparent relationship between the dosage group and the incidence of adverse reactions. The most commonly reported reactions involved the gastrointestinal tract (diarrhoea) or female genital tract (vaginitis). Cefpodoxime proxetil appears to be a useful and safe agent in the therapy of skin and soft tissue infections.

Topics: Abscess; Adolescent; Adult; Aged; Aged, 80 and over; Cefpodoxime Proxetil; Ceftizoxime; Cellulitis; Dose-Response Relationship, Drug; Female; Humans; Male; Middle Aged; Prodrugs; Skin Diseases; Staphylococcal Skin Infections; Streptococcal Infections; Surgical Wound Infection

Concurrently with administering a newly developed cephem derivative antibiotic (CEP), cefpodoxime proxetil (CPDX-PR, CS-807) dry syrup, to children with skin and soft tissue infections, activities of 7 drugs against a group of microorganisms were tested. The drugs tested included 4 drugs of the cephem group, R-3746, a Na-salt form of CPDX, cefaclor (CCL), cephalexin (CEX) and cefadroxil (CDX), and 3 drugs of the penicillin group, ampicillin (ABPC), methicillin (DMPPC) and cloxacillin (MCIPC). The bacterial strains tested were 71 strains of Staphylococcus aureus and 1 strain of Streptococcus pyogenes, all isolated from the above cases of pediatric infections. Inoculum sizes used in these tests were 10(6) and 10(8) cfu/ml. Ages of children in those cases to which the drug was administered ranged from 2 months to 15 years. A total of 66 cases were treated, including 60 cases of impetigo, 5 cases of subcutaneous abscess and 1 case of phlegmon. The drug was administered for an average of 6 days with a daily average dose level of 9.4 mg/kg divided into 3 doses except 1 case where a twice daily dose regimen was used. Clinical and bacteriological effects were examined, and the occurrence of adverse reactions and abnormal laboratory test results were recorded. The results of these tests are summarized below. 1. The activity test for R-3746 (Na-salt of CPDX) against 71 strains of S. aureus performed at an inoculum level of 10(8) cfu/ml showed 2 peaks of MIC values, one in a range of 1.56 to 6.25 micrograms/ml and the other higher than 100 micrograms/ml. The most prevalent MIC value was 3.13 micrograms/ml with MIC against 51 strains or 71.8% of the strains tested showing this value, and MIC values of 25 micrograms/ml or higher were obtained for 13 strains or 18.3% of the strains tested. The MIC80 was 6.25 micrograms/ml. Thus, R-3746 showed an antibacterial activity slightly weaker than MCIPC and DMPPC but similar to CCL, CEX and CDX. MIC values obtained at an inoculum level of 10(6) cfu/ml also had 2 peaks, one in a range of 1.56 to 3.13 micrograms/ml and the other higher than 25 micrograms/ml. Strains against which R-3746 had the MIC value of 3.13 micrograms/ml were the most numerous with 47 strains or 66.2%, and strains against which the MIC value of higher than 25 micrograms/ml was obtained were next with 13 strains or 18.3%.(ABSTRACT TRUNCATED AT 400 WORDS)

Topics: Abscess; Administration, Oral; Adolescent; Bacterial Infections; Cefpodoxime; Cefpodoxime Proxetil; Ceftizoxime; Cellulitis; Child; Child, Preschool; Drug Evaluation; Drug Resistance, Microbial; Female; Humans; Impetigo; Infant; Japan; Male; Multicenter Studies as Topic; Skin Diseases; Staphylococcus aureus; Streptococcus pyogenes

In order to objectively evaluate the effectiveness, safety and usefulness of the new oral cephem cefpodoxime proxetil (CS-807, CPDX-PR) for the treatment of skin and soft tissue infections, a double-blind comparative study was undertaken using cefaclor (CCL) as the control drug. CPDX-PR and CCL were administered for 7 days at daily doses of 400 mg (divided into 2 portions) and 750 mg (divided into 3 portions), respectively. A total of 243 patients (118 in the CPDX-PR group and 125 in the CCL group) was treated in this study. The effectiveness, safety and usefulness were evaluated in 222 (106 in the CPDX-PR group and 116 in the CCL group), 234 (113 in the CPDX-PR group and 121 in the CCL group) and in 223 patients (107 in the CPDX-PR group and 116 in the CCL group), respectively. There were no differences in patients' backgrounds between the 2 groups, except for the presence or the absence of surgical treatments. The results we obtained are summarized below: 1. In the evaluation of clinical efficacy by the subcommittee, excellent, good, fair and poor efficacy were observed in 36, 43, 17 and 10 patients in the CPDX-PR group, respectively; the efficacy rate was, therefore, calculated to be 74.5%. As for the CCL group, respective results were observed in 50, 39, 17 and 10 patients, indicating an efficacy rate of 76.7%. There was no significant difference between the 2 groups. Improvement rates judged by physicians in charge were 80.2% in the CPDX-PR group and 88.8% in the CCL group. Moreover, no significant difference in diseases or severity were found between the 2 groups. 2. As for the bacteriological efficacy, the 2 groups showed high elimination rates, as 90.1% and 91.6% of the disease causing bacteria were eliminated in the CPDX-PR group and in the CCL group, respectively. Elimination rates in single infections with Staphylococcus aureus were determined to be 85.7% in the CPDX-PR group and 85.0% in the CCL group. 3. Although 6 patients in the CPDX-PR group and 2 patients in the CCL group developed side effects, which were mainly gastrointestinal symptoms, there was no significant difference in the incidence of side effects between the 2 groups. Abnormal laboratory values were found in 5 patients in the CPDX-PR group and 1 patient in the CCL group. 4. There was no significant difference in the usefulness between the 2 groups.(ABSTRACT TRUNCATED AT 400 WORDS)

Topics: Abscess; Administration, Oral; Adolescent; Adult; Aged; Cefaclor; Cefpodoxime Proxetil; Ceftizoxime; Cephalexin; Cephalosporins; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Skin Diseases, Infectious; Staphylococcal Infections; Staphylococcus aureus