Abstract |
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.
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Authors | Hiroshi Tanimura, Kazuhisa Uchiyama, Hironobu Onishi, Shigeru Akimoto, Minoru Ochiai, Tadashi Kontani, Yasuhito Kobayasi, Kiyofumi Johata, Tsukasa Hotta, Masaki Sahara, Kazuhito Masaki, Kohei Noguchi, Shinji Iwakura |
Journal | Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy
(J Infect Chemother)
Vol. 9
Issue 1
Pg. 75-82
(Mar 2003)
ISSN: 1341-321X [Print] Netherlands |
PMID | 12673412
(Publication Type: Clinical Trial, Journal Article)
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Chemical References |
- Cephalosporins
- cefcapene pivoxil hydrochloride
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Topics |
- Absorption
- Adult
- Aged
- Aged, 80 and over
- Cephalosporins
(administration & dosage, pharmacokinetics, therapeutic use)
- Communicable Diseases
(drug therapy, microbiology)
- Diarrhea
(drug therapy)
- Feces
(chemistry, microbiology)
- Female
- Gastrointestinal Diseases
(drug therapy)
- Humans
- Male
- Middle Aged
- Treatment Outcome
- Urine
(chemistry)
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