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ROCURONIUM BROMIDE
DIR Classification
Classification:Moderate-DIQT concern
Severity Score:3.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- WARNINGS AND PRECAUTIONS
- QT Interval Prolongation
- The overall analysis of ECG data in pediatric patients indicates that the concomitant use of rocuronium bromide with general anesthetic agents can prolong the QTc interval [see CLINICAL STUDIES (14.3)] .
- USE IN SPECIFIC POPULATIONS
- Pediatric Use
- Rocuronium bromide was also studied in pediatric patients up to 17 years of age, including neonates, under sevoflurane (induction) and isoflurane/nitrous oxide (maintenance) anesthesia. Onset time and clinical duration varied with dose, the age of the patient, and anesthetic technique. The overall analysis of ECG data in pediatric patients indicates that the concomitant use of rocuronium bromide with general anesthetic agents can prolong the QTc interval. The data also suggest that rocuronium bromide may increase heart rate. However, it was not possible to conclusively identify an effect of rocuronium bromide independent of that of anesthesia and other factors. Additionally, when examining plasma levels of rocuronium bromide in correlation to QTc interval prolongation, no relationship was observed [see DOSAGE AND ADMINISTRATION (2.5), WARNINGS AND PRECAUTIONS (5.8), and CLINICAL STUDIES (14.3)] .
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
7
24085
Other ADRs
6241
38375346
Odds Ratio = 1.788
Drug Property Information
ATC Code(s):
- M03AC09 - rocuronium bromide
- M03AC0 -
- M03AC - Other quaternary ammonium compounds
- M03A - "MUSCLE RELAXANTS, PERIPHERALLY ACTING AGENTS"
- M03 - MUSCLE RELAXANTS
- M - MUSCULO-SKELETAL SYSTEM
Active Ingredient:ROCURONIUM BROMIDE
Active Ingredient UNII:I65MW4OFHZ
Drugbank ID:DB00728
PubChem Compound:441290
CTD ID:D000077123
PharmGKB:PA164754992
CAS Number:143558-00-3
Dosage Form(s):injection
Route(s) Of Administrator:intravenous
Daily Dose:
Chemical Structure: 
SMILE Code:
[H][C@@]12C[C@@H]([C@H](OC(C)=O)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC[C@@]2([H])C[C@H](O)[C@H](C[C@]12C)N1CCOCC1)[N+]1(CC=C)CCCC1
[H][C@@]12C[C@@H]([C@H](OC(C)=O)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC[C@@]2([H])C[C@H](O)[C@H](C[C@]12C)N1CCOCC1)[N+]1(CC=C)CCCC1
Reference
N/A
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The content of this database of QT prolongation is intended for educational and scientific research purposes only. It is not intended as a substitute for professional medical advice, diagnosis or treatment.
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