Rocuronium

Rocuronium
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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 Induction of neuromuscular blockade - Intubation, Routine tracheal: 3 mo to 14 yr, initial, (anesthetic technique and age dependent) 0.45 mg/kg IV may be used Induction of neuromuscular blockade - Intubation, Routine tracheal: 3 mo to 14 yr, 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

There is limited information regarding Rocuronium Contraindications in the drug label.

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.