Fosamprenavir overdosage: Difference between revisions
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==Overdosage== | |||
In a healthy volunteer repeat-dose pharmacokinetic trial evaluating high-dose combinations of LEXIVA plus ritonavir, an increased frequency of Grade 2/3 ALT elevations (greater than 2.5 x ULN) was observed with LEXIVA 1,400 mg twice daily plus ritonavir 200 mg twice daily (4 of 25 subjects). Concurrent Grade 1/2 elevations in AST (greater than 1.25 x ULN) were noted in 3 of these 4 subjects. These transaminase elevations resolved following discontinuation of dosing. | |||
<ref>{{Cite web | last = | first = | title = LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=24feb9be-32a6-45fd-a896-f3e202edd8a9 | publisher = | date = | accessdate = }}</ref> | There is no known antidote for LEXIVA. It is not known whether amprenavir can be removed by peritoneal dialysis or hemodialysis. If overdosage occurs, the patient should be monitored for evidence of toxicity and standard supportive treatment applied as necessary.<ref>{{Cite web | last = | first = | title = LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=24feb9be-32a6-45fd-a896-f3e202edd8a9 | publisher = | date = | accessdate = }}</ref> | ||
Revision as of 03:06, 4 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
Overdosage
In a healthy volunteer repeat-dose pharmacokinetic trial evaluating high-dose combinations of LEXIVA plus ritonavir, an increased frequency of Grade 2/3 ALT elevations (greater than 2.5 x ULN) was observed with LEXIVA 1,400 mg twice daily plus ritonavir 200 mg twice daily (4 of 25 subjects). Concurrent Grade 1/2 elevations in AST (greater than 1.25 x ULN) were noted in 3 of these 4 subjects. These transaminase elevations resolved following discontinuation of dosing.
There is no known antidote for LEXIVA. It is not known whether amprenavir can be removed by peritoneal dialysis or hemodialysis. If overdosage occurs, the patient should be monitored for evidence of toxicity and standard supportive treatment applied as necessary.[1]
References
Adapted from the FDA Package Insert.