Verapamil hydrochloride tablet nonclinical toxicology: Difference between revisions
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==NONCLINICAL TOXICOLOGY== | |||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = CALAN (VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=55d5f933-42ff-4c80-a102-0ccb7f76b082#nlm34090-1 | publisher = | date = | accessdate = }}</ref> | ===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 (VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=55d5f933-42ff-4c80-a102-0ccb7f76b082#nlm34090-1 | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
Revision as of 17:44, 4 March 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]
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.[1]