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U.S. Department of Health and Human Services

Safety

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Zemuron (rocuronium bromide) Injection Solution For Intravenous Use August 2008


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Appropriate Administration and Monitoring
  • Residual Paralysis
  • Long-term Use in an Intensive Care Unit
  • QT Interval Prolongation

USE IN SPECIFIC POPULATIONS

  • Pediatric Use

WARNINGS AND PRECAUTIONS

Appropriate Administration and Monitoring

...It is recommended that clinicians administering neuromuscular blocking agents such as Zemuron employ a peripheral nerve stimulator to monitor drug effect, need for additional doses, adequacy of spontaneous recovery or antagonism, and to decrease the complications of overdosage if additional doses are administered.

Residual Paralysis

In order to prevent complications resulting from residual paralysis, it is recommended to extubate only after the patient has recovered sufficiently from neuromuscular block. Other factors which could cause residual paralysis after extubation in the post-operative phase (such as drug interactions or patient condition) should also be considered. If not used as part of standard clinical practice the use of a reversal agent should be considered, especially in those cases where residual paralysis is more likely to occur.

Long-term Use in an Intensive Care Unit

...Myopathy after long term administration of other non-depolarizing neuromuscular blocking agents in the ICU alone or in combination with corticosteroid therapy has been reported. Therefore, for patients receiving both neuromuscular blocking agents and corticosteroids, the period of use of the neuromuscular blocking agent should be limited as much as possible and only used in the setting where in the opinion of the prescribing physician, the specific advantages of the drug outweigh the risk.

QT Interval Prolongation

The overall analysis of ECG data in pediatric patients indicates that the concomitant use of Zemuron with general anesthetic agents can prolong the QTc interval [see Clinical Studies (14.3)].