|
|
| Line 1: |
Line 1: |
| __NOTOC__
| | #REDIRECT [[Carvedilol#Nonclinical Toxicology]] |
| {{Carvedilol}}
| |
| {{CMG}}; {{AE}} {{AZ}}
| |
| | |
| ==Nonclinical Toxicology==
| |
| ===Carcinogenesis, Mutagenesis, Impairment of Fertility===
| |
| | |
| In 2-year studies conducted in rats given carvedilol at doses up to 75 mg/kg/day (12 times the MRHD when compared on a mg/m2 basis) or in mice given up to 200 mg/kg/day (16 times the MRHD on a mg/m2 basis), carvedilol had '''no carcinogenic effect.'''
| |
| | |
| Carvedilol was negative when tested in a battery of [[genotoxicity]] assays, including the Ames and the CHO/HGPRT assays for mutagenicity and the in vitro hamster micronucleus and in vivo human lymphocyte cell tests for clastogenicity.
| |
| | |
| At doses ≥200 mg/kg/day ( ≥ 32 times the MRHD as mg/m2) carvedilol was toxic to adult rats (sedation, reduced weight gain) and was associated with a reduced number of successful matings, prolonged mating time, significantly fewer corpora lutea and implants per dam, and complete resorption of 18% of the litters.
| |
| The '''no-observed-effect dose''' level for overt toxicity and impairment of fertility was 60 mg/kg/day (10 times the MRHD as mg/m2).<ref name="dailymed.nlm.nih.gov">{{Cite web | last = |first = | title = COREG (CARVEDILOL) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c57982f2-c7da-488a-7ea9-b9609439ac68#nlm34089-3 | publisher = | date = | accessdate = }}</ref>
| |
| | |
| ==References==
| |
| {{Reflist}}
| |
| | |
| {{FDA}}
| |
|
| |
|
| | [[Category:Beta Blockers]] |
| [[Category:Cardiovascular Drugs]] | | [[Category:Cardiovascular Drugs]] |
| [[Category:Drugs]] | | [[Category:Drugs]] |