Telavancin overdosage: Difference between revisions
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==Overdosage== | |||
In the event of overdosage, VIBATIV should be discontinued and supportive care is advised with maintenance of [[glomerular filtration]] and careful monitoring of renal function. Following administration of a single dose of VIBATIV 7.5 mg/kg to subjects with end-stage renal disease, approximately 5.9% of the administered dose of telavancin was recovered in the dialysate following 4 hours of [[hemodialysis]]. However, no information is available on the use of hemodialysis to treat an overdosage [see Clinical Pharmacology ]. | |||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = VIBATIV (TELAVANCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5e7c066c-0950-47ce-899d-76881d80c492 | publisher = | date = | accessdate = }}</ref> | The clearance of telavancin by continuous venovenous hemofiltration (CVVH) was evaluated in an in vitro study [see Nonclinical Toxicology (13.2)]. Telavancin was cleared by CVVH and the clearance of telavancin increased with increasing ultrafiltration rate. However, the clearance of telavancin by CVVH has not been evaluated in a clinical study; thus, the clinical significance of this finding and use of CVVH to treat an overdosage is unknown. <ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = VIBATIV (TELAVANCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5e7c066c-0950-47ce-899d-76881d80c492 | publisher = | date = | accessdate = }}</ref> | ||
Latest revision as of 00:01, 10 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
Overdosage
In the event of overdosage, VIBATIV should be discontinued and supportive care is advised with maintenance of glomerular filtration and careful monitoring of renal function. Following administration of a single dose of VIBATIV 7.5 mg/kg to subjects with end-stage renal disease, approximately 5.9% of the administered dose of telavancin was recovered in the dialysate following 4 hours of hemodialysis. However, no information is available on the use of hemodialysis to treat an overdosage [see Clinical Pharmacology ].
The clearance of telavancin by continuous venovenous hemofiltration (CVVH) was evaluated in an in vitro study [see Nonclinical Toxicology (13.2)]. Telavancin was cleared by CVVH and the clearance of telavancin increased with increasing ultrafiltration rate. However, the clearance of telavancin by CVVH has not been evaluated in a clinical study; thus, the clinical significance of this finding and use of CVVH to treat an overdosage is unknown. [1]
References
Adapted from the FDA Package Insert.