Argatroban nonclinical toxicology: Difference between revisions
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(Created page with "__NOTOC__ {{Argatroban}} {{CMG}}; {{AE}} {{JH}} ==TITLE== <ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ARGATROBAN INJECTION, SOLUTION [GLAXO...") |
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== | ==Nonclinical Toxicology== | ||
====13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility==== | |||
Carcinogenicity studies with argatroban have not been performed. | |||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ARGATROBAN INJECTION, SOLUTION [GLAXOSMITHKLINE LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c9616c0-a299-4fd5-c8ae-79e6db453595 | publisher = | date = | accessdate = }}</ref> | Argatroban was not genotoxic in the Ames test, the Chinese hamster ovary cell (CHO/HGPRT) forward mutation test, the Chinese hamster lung fibroblast chromosome aberration test, the rat hepatocyte, and WI-38 human fetal lung cell unscheduled DNA synthesis (UDS) tests, or the mouse micronucleus test. | ||
Argatroban at intravenous doses up to 27 mg/kg/day (0.3 times the recommended maximum human dose based on body surface area) had no effect on fertility and reproductive function of male and female rats.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ARGATROBAN INJECTION, SOLUTION [GLAXOSMITHKLINE LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c9616c0-a299-4fd5-c8ae-79e6db453595 | publisher = | date = | accessdate = }}</ref> | |||
==Reference== | ==Reference== | ||
Revision as of 21:39, 4 March 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Jesus Rosario Hernandez, M.D. [2]
Nonclinical Toxicology
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies with argatroban have not been performed.
Argatroban was not genotoxic in the Ames test, the Chinese hamster ovary cell (CHO/HGPRT) forward mutation test, the Chinese hamster lung fibroblast chromosome aberration test, the rat hepatocyte, and WI-38 human fetal lung cell unscheduled DNA synthesis (UDS) tests, or the mouse micronucleus test.
Argatroban at intravenous doses up to 27 mg/kg/day (0.3 times the recommended maximum human dose based on body surface area) had no effect on fertility and reproductive function of male and female rats.[1]
Reference
Adapted from the FDA Package Insert.