Prazosin nonclinical toxicology: Difference between revisions

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#REDIRECT [[Prazosin#Nonclinical Toxicology]]
{{Prazosin}}
{{CMG}}; {{AE}} {{AK}}
 
==NONCLINICAL TOXICOLOGY==
 
===Carcinogenesis, Mutagenesis, Impairment of Fertility===
 
No carcinogenic potential was demonstrated in an 18 month study in rats with MINIPRESS at dose levels more than 225 times the usual maximum recommended human dose of 20 mg per day. MINIPRESS was not mutagenic in in vivo genetic toxicology studies. In a fertility and general reproductive performance study in rats, both males and females, treated with 75 mg/kg (225 times the usual maximum recommended human dose), demonstrated decreased fertility, while those treated with 25 mg/kg (75 times the usual maximum recommended human dose) did not.
 
In chronic studies (one year or more) of MINIPRESS in rats and dogs, testicular changes consisting of atrophy and necrosis occurred at 25 mg/kg/day (75 times the usual maximum recommended human dose). No testicular changes were seen in rats or dogs at 10 mg/kg/day (30 times the usual maximum recommended human dose). In view of the testicular changes observed in animals, 105 patients on long term MINIPRESS therapy were monitored for 17-ketosteroid excretion and no changes indicating a drug effect were observed. In addition, 27 males on MINIPRESS for up to 51 months did not have changes in sperm morphology suggestive of drug effect.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = MINIPRESS (PRAZOSIN HYDROCHLORIDE) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=36c4da56-502e-4da1-acf7-8e81ee453dcc | publisher =  | date =  | accessdate = 6 March 2014 }}</ref>
 
 
 
==References==
 
{{Reflist|2}}
 
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]

Latest revision as of 23:11, 21 July 2014