Anidulafungin overdosage: Difference between revisions
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{{CMG}}; {{AE}} {{AZ}} | {{CMG}}; {{AE}} {{AZ}} | ||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a88d9010-55fb-4a02-baff-042cd27688ea | publisher = | date = | accessdate = }}</ref> | ==Overdosage== | ||
During clinical trials a single 400 mg dose of ERAXIS was inadvertently administered as a loading dose. No clinical adverse events were reported. In a study of 10 healthy subjects administered a loading dose of 260 mg followed by 130 mg daily, ERAXIS was generally well tolerated; 3 of the 10 subjects experienced transient, asymptomatic transaminase elevations (≤3 x ULN) [see Warnings and Precautions (5.1)]. | |||
'''Anidulafungin''' is '''not dialyzable'''. | |||
The maximum non-lethal dose of anidulafungin in rats was 50 mg/kg, a dose which is equivalent to 10 times the recommended daily dose for esophageal candidiasis (50 mg/day) or equivalent to 5 times the recommended daily dose for candidemia and other Candida infections (100 mg/day), based on relative body surface area comparisons.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a88d9010-55fb-4a02-baff-042cd27688ea | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
Revision as of 01:10, 9 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
Overdosage
During clinical trials a single 400 mg dose of ERAXIS was inadvertently administered as a loading dose. No clinical adverse events were reported. In a study of 10 healthy subjects administered a loading dose of 260 mg followed by 130 mg daily, ERAXIS was generally well tolerated; 3 of the 10 subjects experienced transient, asymptomatic transaminase elevations (≤3 x ULN) [see Warnings and Precautions (5.1)].
Anidulafungin is not dialyzable.
The maximum non-lethal dose of anidulafungin in rats was 50 mg/kg, a dose which is equivalent to 10 times the recommended daily dose for esophageal candidiasis (50 mg/day) or equivalent to 5 times the recommended daily dose for candidemia and other Candida infections (100 mg/day), based on relative body surface area comparisons.[1]
References
Adapted from the FDA Package Insert.