Preliminary dose finding study for subacute toxicological study of pravastatin sodium in monkeys.
Pravastatin sodium was orally administered to cynomolgus monkeys at dosage levels of 50, 200 and 800 mg/kg/day for 7 successive days. Excretion of diarrhea and/or loose stool were observed in the more than 50 mg/kg dose group, but the changes are quite mild. Animals of the 800 mg/kg dose group showed vomiting, diarrhea and/or excretion of soft stool and reduction of cholesterol content in serum. In conclusion, it is estimated that the no effective level is less than 200 mg/kg because no abnormalities were observed except for only very slight excretions of diarrhea and/or loose stool, and that the effective dose is 800 mg/kg in which vomiting was observed.
Manabe
S
S
Laboratory Animal Science and Toxicology Laboratories, Sankyo Shizuoka, Japan.
Sudo
S
S
Yamashita
K
K
Miyakoshi
N
N
Matsunuma
N
N
Masuda
H
H
D000284:Administration, Oral; D000410:Alanine Transaminase / Q000097:blood; D000818:Animals; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000633:toxicity*; D001219:Aspartate Aminotransferases / Q000097:blood; D001831:Body Temperature / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D002784:Cholesterol / Q000097:blood; D003967:Diarrhea / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004435:Eating / Q000187:drug effects; D005260:Female; D006403:Hematologic Tests; D006538:Heptanoic Acids; D008252:Macaca fascicularis; D008297:Male; D009281:Naphthalenes; D009929:Organ Size / Q000187:drug effects; D017035:Pravastatin
D000924:Anticholesteremic Agents; D006538:Heptanoic Acids; D009281:Naphthalenes; D002784:Cholesterol; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D017035:Pravastatin