INTUNIV nonclinical toxicology: Difference between revisions

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(Created page with "__NOTOC__ {{Guanfacine}} {{CMG}}; {{AE}} {{SS}} ==Nonclinical Toxicology== ===13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility=== ====Carcinogenesis==== No carcino...")
 
 
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__NOTOC__
#REDIRECT [[Guanfacine#Nonclinical Toxicology]]
{{Guanfacine}}
{{CMG}}; {{AE}} {{SS}}
 
==Nonclinical Toxicology==
 
===13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility===
 
====Carcinogenesis====
No carcinogenic effect of guanfacine was observed in studies of 78 weeks in mice or 102 weeks in rats at doses up to 6-7 times the maximum recommended human dose of 4 mg/day on a mg/ m2 basis.
 
====Mutagenesis====
Guanfacine was not genotoxic in a variety of test models, including the Ames test and an in vitro chromosomal aberration test; however, a marginal increase in numerical aberrations (polyploidy) was observed in the latter study.
 
====Impairment of Fertility====
No adverse effects were observed in fertility studies in male and female rats at doses up to 30 times the maximum recommended human dose on a mg/ m2 basis.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b972af81-3a37-40be-9fe1-3ddf59852528#section-12.1 | publisher =  | date =  | accessdate = 25 February 2014 }}</ref>
 
==References==
{{reflist|2}}
 
{{Antihypertensives and diuretics}}
{{Antihyperkinetics}}
{{Adrenergics}}
 
[[Category:Antihypertensive agents]]
[[Category:Guanidines]]
[[Category:Alpha-adrenergic agonists]]
[[Category:Acetamides]]
[[Category:Organochlorides]]
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]

Latest revision as of 03:56, 22 July 2014