cefmenoxime and Otitis-Media--Suppurative

One percent cefmenoxime (CMX) ototopical solution was administered to 302 patients with purulent otitis media and acute diffuse external otitis in open study fashion, and to 216 patients with purulent otitis media in double blind condition. From among the total of 518 cases various bacteria were detected, except 22 of negative detection after incubation and 3 of impossible determination. The main bacteria detected from the above 493 cases were S. aureus (242 strains = 49.1%), P. aeruginosa (105 strains = 21.3%), S. epidermidis (67 strains = 13.6%), Proteus spp. (indole positive) (31 strains = 6.3%) and P. mirabilis (24 strains = 4.9%) as well as anaerobic bacteria (26 strains = 5.3%). MIC of CMX against those bacteria detected was evaluated at 10(8) CFU/ml and 10(6) CFU/ml, respectively, up to the concentration of 800 micrograms/ml, with MIC of cefazolin (CEZ), chloramphenicol (CP) and fradiomycin (FRM) as the references. With respect to the antibacterial action of CMX against S. aureus, MIC50 of CMX was inferior to that of CEZ by 4-fold, but its MIC80 and MIC90 are almost equivalent to those of CEZ. These results were obtained because there existed relatively few CMX highly resistant strains, while more than 20% strains are said to resist cephem antibiotics. As far as MIC of CMX against P. aeruginosa was concerned, the MIC reached its peak with 100 micrograms/ml at the concentration of 10(8) CFU/ml and with 25 micrograms/ml at 10(6) CFU/ml, respectively, which indicated the real antibacterial value of CMX against P. aeruginosa. However, the strains which showed higher MIC of greater than 800 micrograms/ml were rather few, that is, only 8 out of 105 (7.6%). Antibacterial action of CMX against Streptococcus (except Enterococcus), GNR from intestinal bacteria and anaerobic bacteria was favorable, and the stable and strong antibacterial action was shown against C. freundii, Enterobacter spp., S. marcescens and Proteus spp. (indole positive) which produce chromosome mediated beta-lactamase. On the other hand, the antibacterial action of CMX against GNF-GNR except P. aeruginosa was unfavorable for P. cepacia, P. putida and A. xylosoxidans, but relatively favorable for A. calcoaceticus. As a result of MIC evaluation of reference drugs, S. aureus was resistant to CEZ, and Proteus spp. (indole-positive) was resistant to CP, while FRM was highly resisted by almost all strains of bacteria. However, the resistance rate of S. aureus to CP was relatively low, that is,

Topics: Administration, Topical; Bacteria; Cefmenoxime; Cefotaxime; Clinical Trials as Topic; Double-Blind Method; Drug Resistance, Microbial; Humans; Otitis Externa; Otitis Media; Otitis Media, Suppurative; Solutions

Serum concentrations and urinary recovery rates of cefmenoxime (CMX) were determined in 41 mature and premature infants (with ages 0-24 days) after one shot intravenous injection of 10, 20 (1-hour intravenous drip infusion was also carried out) or 30 mg/kg for treatment and prophylaxis of various infections. Because the number of cases included was small, a comparison study was conducted by classifying them into 3 groups; 3 days or younger, 4 to 7 days, and 8 days or older, rather than dividing them into groups of mature and premature infants. Clinical evaluation was conducted in 7 male and 1 female cases 1 to 29 days old, whose diseases comprised 1 case each with septicemia, purulent otitis media and phlegmonous cellulitis, 3 with pneumonia and 2 with urinary tract infection. 1. Changes in serum concentrations and urinary recovery rates (1) Intravenous bolus injection of 10 mg/kg: Serum concentrations of the drug in the 3 age groups peaked at 28.9, 29.5 and 29.1 micrograms/ml, respectively, all at 30 minutes after the drug administration, and thereafter gradually declined. The mean level in the 3rd group was the lowest at 1.9 micrograms/ml at 6 hours. Average serum half-lives of CMX were shorter in older subjects, 3.0, 1.9 and 1.4 hours, respectively in the 3 groups. Urinary recovery rates were relatively high, 68.9 to 84.9% in the 3 cases examined during the first 6 hours, and 15.4 to 66.2% during the first 2 hours. (2) Intravenous bolus injection of 20 mg/kg: Serum concentrations of the drug in the 3 groups peaked at 65.2, 60.5 and 65.8 micrograms/ml, respectively, all at 30 minutes after the drug administration, with no significant differences noted among the groups. The levels gradually declined thereafter in all groups, but remained rather high at 20.1, 6.5 and 9.5 micrograms/ml, respectively, at 6 hours. Average serum half-lives of CMX were 3.5, 1.7 and 1.9 hours, respectively. The inversion of values obtained between the 2nd and 3rd groups appears to be attributable to that all of the 3rd group were premature infants, and the body weight of 2 cases of them were less than 2,000 g each. Urinary recovery rates ranged widely from 37.0 to 89.4% in the 4 cases examined during the first 6 hours. (3) One-hour intravenous drip infusion of 20 mg/kg: Serum concentrations of the drug in the 3 groups peaked at 57.7, 60.2 and 72.4 micrograms/ml, respectively, all at the termination of the drug infusion.(ABSTRACT TRUNCATED AT 400 WORDS)

Topics: Bacterial Infections; Cefmenoxime; Cellulitis; Drug Evaluation; Female; Humans; Infant, Newborn; Infant, Premature, Diseases; Male; Otitis Media, Suppurative; Pneumonia; Sepsis; Urinary Tract Infections