1994 Volume 42 Issue Supplement4 Pages 130-155
The present studies were conducted to evaluate the potential toxicities of biapenem (BIPM), a new carbapenem antibiotic, when intravenously administered to rats. Animals were given BIPM intravenously at a dose level of 10, 30, 100, 300 or 600mg/kg/day for one month, and 30, 100, 300 or 600 mg/kg/day for three months. The results obtained are summarized as follows:
1. There were no deaths related to the drug treatment in these studies. Soft or watery feces were observed in the animals with a dose-dependent relationship. This change recovered following cessation of drug treatment.
2. A slight decrease in body weight gain was seen in the animals given 600 mg/kg/day in the 1 and 3 month toxicity studies.
3. A significant increase in the kidney weight was seen at the end of the dosing period in the highdose group of the 3 month toxicity study. Cloudy swelling of the tubular epithelium in renal cortex was also observed histopathologically in these animals. The spleen and cecum weights increased slightly with a dose-dependent relationship. Cecal enlargement is a common finding in rodents treated with antibacterial agents. Since there were no abnormal histopathological changes in the cecum and spleen, these weight changes were not the toxicologic effects of the drug.
