Rocuronium
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
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Overview
Rocuronium is a skeletal muscle relaxant, neuromuscular blocking drug that is FDA approved for the {{{indicationType}}} of general anesthesia; adjunct - induction of neuromuscular blockade, during surgery or mechanical ventilation, induction of neuromuscular blockade intubation, routine tracheal, rapid sequence intubation.. Common adverse reactions include cardiovascular: hypertension (0.1% to 2% ), hypotension (0.1% to 2% ), tachycardia (less than 1% to 5.3% )dermatologic: injection site pain, respiratory: Increased pulmonary vascular resistance (24% ).
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Dosage should be individualized and guided by neuromuscular transmission recovery.
- General anesthesia; Adjunct
- Induction of neuromuscular blockade, During surgery or mechanical ventilation
- Initial, 0.6 mg/kg IV
- Maintenance, 0.1 to 0.2 mg/kg IV push, repeat as needed or 0.01 to 0.012 mg/kg/minute continuous IV infusion.
- Induction of neuromuscular blockade - Intubation, Routine tracheal
- Initial, (regardless of anesthesic technique) 0.6 mg/kg IV; or a lower dose of 0.45 mg/kg IV may be used.
- Initial, (with opioid/nitrous oxide/oxygen anesthesia) 0.9 or 1.2 mg/kg large bolus may be used.
- Maintenance, (only after spontaneous recovery from intubation dose) 0.1 to 0.2 mg/kg IV , repeat as needed or 0.01 to 0.012 mg/kg/minute continuous IV infusion.
- Premedication for anesthetic procedure
- Preinduction defasciculating dose: 0.05 to 0.06 mg/kg IV 1.5-3 min prior to succinylcholine administration.
- Rapid sequence intubation: 0.6 to 1.2 mg/kg IV.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
- Premedication for anesthetic procedure, Preinduction defasciculating dose.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Rocuronium in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
- General anesthesia; Adjunct
- Induction of neuromuscular blockade, during surgery or mechanical ventilation: 3 mo to 14 yr
- Initial, 0.6 mg/kg/dose IV
- Maintenance, 0.075 to 0.15 mg/kg IV push as needed (anesthetic agent dependent) or 0.012 mg/kg/min continuous IV infusion
- Induction of neuromuscular blockade - Intubation, Routine tracheal: 3 mo to 14 yr
- Initial, 0.6 mg/kg/dose IV
- Initial, (anesthetic technique and age dependent) 0.45 mg/kg IV may be used
- Maintenance, 0.075 to 0.125 mg/kg IV push as needed or 0.012 mg/kg/min continuous IV infusion
- Rapid sequence intubation: not recommended in pediatric patients although 0.6 to 1.2 mg/kg IV have been used in clinical trials
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Premedication for anesthetic procedure, Preinduction defasciculating dose
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Rocuronium in pediatric patients.
Contraindications
ZEMURON is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents.
Warnings
There is limited information regarding Rocuronium Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Rocuronium Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Rocuronium Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Rocuronium Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Rocuronium in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Rocuronium in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Rocuronium during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Rocuronium in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Rocuronium in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Rocuronium in geriatric settings.
Gender
There is no FDA guidance on the use of Rocuronium with respect to specific gender populations.
Race
There is no FDA guidance on the use of Rocuronium with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Rocuronium in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Rocuronium in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Rocuronium in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Rocuronium in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Rocuronium Administration in the drug label.
Monitoring
There is limited information regarding Rocuronium Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Rocuronium and IV administrations.
Overdosage
There is limited information regarding Rocuronium overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Rocuronium Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Rocuronium Mechanism of Action in the drug label.
Structure
There is limited information regarding Rocuronium Structure in the drug label.
Pharmacodynamics
There is limited information regarding Rocuronium Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Rocuronium Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Rocuronium Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Rocuronium Clinical Studies in the drug label.
How Supplied
There is limited information regarding Rocuronium How Supplied in the drug label.
Storage
There is limited information regarding Rocuronium Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Rocuronium Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Rocuronium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Rocuronium Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Rocuronium Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.