Study of the absorption of cefcapene pivoxil in patients with infectious disease and soft stool or diarrhea.
Cefcapene pivoxil hydrochloride (CFPN-PI), an ester cephem antibiotic, was orally given at a dose of 100 mg three times daily in patients with infection and soft stool or diarrhea, and its absorption was determined using the recovery ratio of 12-h urine pooled after the initial administration as an index. The primary endpoint, the recovery ratio of 12-h urine pooled after oral administration, could be evaluated in six of the eight patients finally gathered, and the mean value was 30.1 +/- 5.8%, which was not considered to differ from the mean value of 34.4 +/- 5.5% obtained in six healthy adult volunteers in the previous phase I study. Clinical efficacy in the eight patients was rated as very effective, effective, and ineffective in two, five, and one patients, respectively, with an effective ratio of 87.5% (7/8). Neither adverse drug reactions nor abnormal laboratory data were observed in any patient. These results indicate that CFPN-PI, at the routine oral dose, does not cause any problems in terms of absorption, efficacy, and safety when it is used in patients with infection and soft stool or diarrhea.
Tanimura
Hiroshi
H
Second Department of Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-8510, Japan.
Uchiyama
Kazuhisa
K
Onishi
Hironobu
H
Akimoto
Shigeru
S
Ochiai
Minoru
M
Kontani
Tadashi
T
Kobayasi
Yasuhito
Y
Johata
Kiyofumi
K
Hotta
Tsukasa
T
Sahara
Masaki
M
Masaki
Kazuhito
K
Noguchi
Kohei
K
Iwakura
Shinji
S
D000042:Absorption; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002511:Cephalosporins / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D003141:Communicable Diseases / Q000188:drug therapy* / Q000382:microbiology; D003967:Diarrhea / Q000188:drug therapy*; D005243:Feces / Q000737:chemistry / Q000382:microbiology; D005260:Female; D005767:Gastrointestinal Diseases / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014556:Urine / Q000737:chemistry*
D002511:Cephalosporins; C425944:cefcapene pivoxil hydrochloride