Verapamil hydrochloride tablet extended release nonclinical toxicology: Difference between revisions

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#REDIRECT [[Verapamil#Nonclinical Toxicology]]
{{Verapamil}}
{{CMG}}; {{AE}} {{AK}}
 
==NONCLINICAL TOXICOLOGY==
 
===Carcinogenesis, mutagenesis, impairment of fertility===
 
An 18-month toxicity study in rats, at a low multiple (6-fold) of the maximum recommended human dose, and not the maximum tolerated dose, did not suggest a tumorigenic potential. There was no evidence of a carcinogenic potential of verapamil administered in the diet of rats for two years at doses of 10, 35, and 120 mg/kg/day or approximately 1, 3.5, and 12 times, respectively, the maximum recommended human daily dose (480 mg/day or 9.6 mg/kg/day).
 
Verapamil was not mutagenic in the Ames test in 5 test strains at 3 mg per plate with or without metabolic activation.
 
Studies in female rats at daily dietary doses up to 5.5 times (55 mg/kg/day) the maximum recommended human dose did not show impaired fertility. Effects on male fertility have not been determined.
 
 
===Animal pharmacology and/or animal toxicology===
 
In chronic animal toxicology studies, verapamil caused lenticular and/or suture line changes at 30 mg/kg/day or greater, and frank cataracts at 62.5 mg/kg/day or greater in the beagle dog but not in the rat. Development of [[cataracts ]]due to verapamil has not been reported in man.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = CALAN SR (VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [G.D. SEARLE LLC DIVISION OF PFIZER INC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=acb6e57b-af44-432f-a4de-a293a2e20121#nlm34090-1 | publisher =  | date =  | accessdate =  }}</ref>
 
 
==References==
 
{{Reflist|2}}
 
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]

Latest revision as of 01:49, 22 July 2014