cefzil and Vomiting

In order to investigate the single dose oral toxicity of BMY-28100 in juvenile animals, the drug was administered in single doses to 4-day-old and 14-day-old Crj: CD (SD) rats of both sexes at a dose of 2,000 mg/kg, and to 4-week-old beagle dogs of both sexes at doses of 500, 1,000 and 2,000 mg/kg by oral route. The results obtained are summarized as follows: 1. In rats, decreases of the body weight gain were observed for male and female rats treated with the drug on postnatal day 4 through 5 days and 3 days after dosing, respectively. There were no apparent drug-related toxic signs. No deaths occurred during the observation period. Enlargement of the cecum was found in a few rats of both sexes administered the drug on postnatal day 4 or 14. 2. In dogs, watery-mucous diarrhea observed at 2 to 3 hours after dosing in all dose groups was not dose-related. This finding lasted in some dogs till 4 days after dosing. An increased incidence of emesis was induced in all males at 2,000 mg/kg and all females of all dose groups except one female at 2,000 mg/kg. Body weights increased normally for all dogs, but one male at 1,000 mg/kg showed a transient decrease in food consumption. No drug-related histopathological changes were found. Based upon these results, BMY-28100 at 2,000 mg/kg induced no apparent toxic changes in the present experimental conditions. Therefore, the single dose oral toxicity of the drug in juvenile animals appeared to be very slight and generally similar to that in adults.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Oral; Age Factors; Animals; Body Weight; Cefprozil; Cephalosporins; Diarrhea; Dogs; Eating; Female; Heart; Male; Organ Size; Rats; Rats, Inbred Strains; Spleen; Stomach; Vomiting

Three groups, each consisting of 3 male and 3 female juvenile beagle dogs, were orally given BMY-28100 for 4 weeks at dose levels of 50, 160 and 500 mg/kg/day, respectively. Additionally, one male and one female dogs were added to each of the control and high dose groups in order to examine the recovery, and observed for 4 weeks after withdrawal of BMY-28100. The results obtained are summarized as follows: 1. BMY-28100 provoked an increased incidence of emesis in the 500 mg/kg group during the treatment period. 2. BMY-28100 sporadically brought distention of the cecum containing considerable amounts of contents in dogs sacrificed after the 4-week administration period. However, no macroscopic or microscopic changes were observed in the cecum itself after removal of the contents. In the 500 mg/kg group, hypocellularity in the sternum bone marrow was observed in a male and a female, and thymic atrophy in a male. 3. No changes ascribed to BMY-28100 treatment were detected after the 4-week recovery period. Based upon these results, the no-effect dose level of BMY-28100 was estimated to be 160 mg/kg/day, except for effects on the cecum.

Topics: Administration, Oral; Age Factors; Animals; Bone Marrow; Bone Marrow Cells; Cecum; Cefprozil; Cephalosporins; Dogs; Female; Hematologic Tests; Male; Thymus Gland; Time Factors; Vomiting