Cordarone tablet nonclinical toxicology: Difference between revisions
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Amiodarone HCl was associated with a statistically significant, dose-related increase in the incidence of thyroid tumors (follicular adenoma and/or carcinoma) in rats. The incidence of thyroid tumors was greater than control even at the lowest dose level tested, i.e., 5 mg/kg/day (approximately 0.08 times the maximum recommended human maintenance dose*). | Amiodarone HCl was associated with a statistically significant, dose-related increase in the incidence of thyroid tumors (follicular adenoma and/or carcinoma) in rats. The incidence of thyroid tumors was greater than control even at the lowest dose level tested, i.e., 5 mg/kg/day (approximately 0.08 times the maximum recommended human maintenance dose*). | ||
Mutagenicity studies (Ames, micronucleus, and lysogenic tests) with Cordarone were negative. | Mutagenicity studies (Ames, micronucleus, and lysogenic tests) with Cordarone were negative. | ||
In a study in which amiodarone HCl was administered to male and female rats, beginning 9 weeks prior to mating, reduced fertility was observed at a dose level of 90 mg/kg/day (approximately 1.4 times the maximum recommended human maintenance dose*). | In a study in which amiodarone HCl was administered to male and female rats, beginning 9 weeks prior to mating, reduced fertility was observed at a dose level of 90 mg/kg/day (approximately 1.4 times the maximum recommended human maintenance dose<sup>'''*'''</sup>). | ||
*600 mg in a 50 kg patient (dose compared on a body surface area basis) | |||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = CORDARONE (AMIODARONE HYDROCHLORIDE) TABLET [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=51be39a2-9134-402c-95ad-defe47406ff8 | publisher = | date = | accessdate = }}</ref> | '''*''' 600 mg in a 50 kg patient ( dose compared on a body surface area basis )<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = CORDARONE (AMIODARONE HYDROCHLORIDE) TABLET [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=51be39a2-9134-402c-95ad-defe47406ff8 | publisher = | date = | accessdate = }}</ref> | ||
==References== | ==References== | ||
Latest revision as of 17:20, 12 March 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Amiodarone HCl was associated with a statistically significant, dose-related increase in the incidence of thyroid tumors (follicular adenoma and/or carcinoma) in rats. The incidence of thyroid tumors was greater than control even at the lowest dose level tested, i.e., 5 mg/kg/day (approximately 0.08 times the maximum recommended human maintenance dose*). Mutagenicity studies (Ames, micronucleus, and lysogenic tests) with Cordarone were negative. In a study in which amiodarone HCl was administered to male and female rats, beginning 9 weeks prior to mating, reduced fertility was observed at a dose level of 90 mg/kg/day (approximately 1.4 times the maximum recommended human maintenance dose*).
* 600 mg in a 50 kg patient ( dose compared on a body surface area basis )[1]
References
Adapted from the FDA Package Insert.