Bivalirudin overdosage: Difference between revisions

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==Title==
==Overdosage==


 
Cases of overdose of up to 10 times the recommended bolus or continuous infusion dose of Angiomax have been reported in clinical trials and in postmarketing reports. A number of the reported overdoses were due to failure to adjust the infusion dose of bivalirudin in persons with renal dysfunction including persons on hemodialysis [see Dosage and Administration (2.2)]. Bleeding, as well as deaths due to hemorrhage, have been observed in some reports of overdose. In cases of suspected overdosage, discontinue Angiomax immediately and monitor the patient closely for signs of bleeding. There is no antidote to Angiomax. Angiomax is hemodialyzable [see Clinical Pharmacology (12.3)].<ref>{{Cite web  | last =  | first =  | title = ANGIOMAX (BIVALIRUDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=911cd48f-01ea-4dec-b30c-95e7e0ea9d2a | publisher =  | date =  | accessdate = 10 March 2014 }}</ref>
 
<ref>{{Cite web  | last =  | first =  | title = ANGIOMAX (BIVALIRUDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=911cd48f-01ea-4dec-b30c-95e7e0ea9d2a | publisher =  | date =  | accessdate = 10 March 2014 }}</ref>


==References==
==References==

Revision as of 18:16, 10 March 2014

Bivalirudin
ANGIOMAX® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Bivalirudin
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-in-Chief: Jesus Rosario Hernandez, M.D. [2]

Overdosage

Cases of overdose of up to 10 times the recommended bolus or continuous infusion dose of Angiomax have been reported in clinical trials and in postmarketing reports. A number of the reported overdoses were due to failure to adjust the infusion dose of bivalirudin in persons with renal dysfunction including persons on hemodialysis [see Dosage and Administration (2.2)]. Bleeding, as well as deaths due to hemorrhage, have been observed in some reports of overdose. In cases of suspected overdosage, discontinue Angiomax immediately and monitor the patient closely for signs of bleeding. There is no antidote to Angiomax. Angiomax is hemodialyzable [see Clinical Pharmacology (12.3)].[1]

References

  1. "ANGIOMAX (BIVALIRUDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY]". Retrieved 10 March 2014.

Adapted from the FDA Package Insert.