Long term oral administration study of pravastatin sodium to beagles for 104 weeks.
Pravastatin sodium was successively given for 104 weeks to beagles orally at doses of 5 and 25 mg/kg/day. A decrease in serum cholesterol levels was observed at week 4 and thereafter. No other abnormal findings were obtained in any animals in general conditions, hematological and biochemical examination, various function tests, and pathological examinations. The no-effect dose level in beagles receiving pravastatin sodium orally for 104 weeks is toxicologically estimated to be more than 25 mg/kg/day.
Tarumi
C
C
Laboratory Animal Science and Toxicology Laboratories, Sankyo Co., Ltd., Japan.
Matsunuma
N
N
Miyakoshi
N
N
Yamashita
K
K
Masuda
H
H
D000818:Animals; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000633:toxicity*; D001835:Body Weight / Q000187:drug effects; D004285:Dogs; D004562:Electrocardiography; D004596:Electroretinography; D004971:Estrus / Q000187:drug effects; D005260:Female; D006403:Hematologic Tests; D006538:Heptanoic Acids; D007677:Kidney Function Tests; D008111:Liver Function Tests; D008297:Male; D009281:Naphthalenes; D009780:Occult Blood; D009887:Ophthalmoscopy; D009929:Organ Size / Q000187:drug effects; D017035:Pravastatin; D013997:Time Factors; D016482:Urinalysis
D000924:Anticholesteremic Agents; D006538:Heptanoic Acids; D009281:Naphthalenes; D017035:Pravastatin