Rocuronium Bromide (Monograph)

Drug class: Neuromuscular Blocking Agents

Medically reviewed by Drugs.com on Sep 10, 2024. Written by ASHP.

Introduction

Nondepolarizing neuromuscular blocking agent; aminosteroid.

Uses for Rocuronium Bromide

Skeletal Muscle Relaxation

Production of skeletal muscle relaxation during surgery after general anesthesia has been induced.

Facilitation of endotracheal intubation (rapid sequence and routine tracheal intubation).

Also has been used to facilitate mechanical ventilation in the ICU; however, manufacturer states that prolonged use in this setting has not been evaluated. Whenever neuromuscular blocking agents are used in the ICU, consider benefits versus risks of such therapy and assess patients frequently to determine need for continued paralysis. (See Intensive Care Setting under Cautions.)

Compared with other neuromuscular blocking agents, rocuronium has a rapid onset and intermediate duration of action. Recommended as an alternative to succinylcholine for rapid sequence intubation. When given in sufficient doses (e.g., ≥1 mg/kg), produces similar intubating conditions to succinylcholine.

Rocuronium Bromide Dosage and Administration

General

Dispensing and Administration Precautions

• Facilities and personnel necessary for intubation, administration of oxygen, and respiratory support should be immediately available. (See Boxed Warning.)

• Take special precautions (e.g., segregate storage, limit access, affix warning labels to storage containers and final administration containers) to ensure that the drug is not administered without adequate respiratory support. Institute for Safe Medication Practices (ISMP) recommends the following wording on auxiliary labels: “Warning: Paralyzing agent—causes respiratory arrest—patient must be ventilated.”

• Assess neuromuscular blockade and recovery with a peripheral nerve stimulator to accurately monitor the degree of muscle relaxation, determine need for additional doses, and minimize possibility of overdosage. (See Administration Precautions under Cautions.)

• To avoid patient distress, administer in conjunction with adequate analgesia and sedation, and only after unconsciousness has been induced.

• A reversal agent should be readily available in the event of a failed intubation or to accelerate neuromuscular recovery after surgery. (See Reversal of Neuromuscular Blockade under Dosage and Administration.)

Reversal of Neuromuscular Blockade

• To reverse neuromuscular blockade, administer a cholinesterase inhibitor (e.g., neostigmine, pyridostigmine, edrophonium) in conjunction with an anticholinergic agent such as atropine or glycopyrrolate to block adverse muscarinic effects of the cholinesterase inhibitor. Alternatively, may use sugammadex to reverse the effects of rocuronium after surgery.

• To minimize risk of residual neuromuscular blockade, attempt reversal only after some degree of spontaneous recovery has occurred; monitor patients closely until adequate recovery of normal neuromuscular function is assured (i.e., ability to maintain satisfactory ventilation and a patent airway).

Administration

IV Administration

Administer IV only. Administer initial (intubating) dose by rapid IV injection; administer maintenance doses by intermittent IV injection or continuous IV infusion.

Use of a controlled-infusion device recommended during continuous IV infusion.

Rate of spontaneous recovery following discontinuance of a maintenance infusion usually is comparable to that following administration of intermittent IV injections.

If extravasation occurs, discontinue administration of the drug immediately and restart in another vein.

Consult specialized references for specific procedures and techniques of administration.

Do not mix in the same syringe or administer through the same needle as an alkaline solution.

Dilution

For continuous IV infusion, dilute rocuronium bromide injection to the desired concentration (e.g., 0.5, 1, or 5 mg/mL) in a compatible IV infusion solution. Use within 24 hours.

Standardize 4 Safety

Standardized concentrations for rocuronium have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care. Because recommendations from the S4S panels may differ from the manufacturer’s prescribing information, caution is advised when using concentrations that differ from labeling, particularly when using rate information from the label. For additional information on S4S (including updates that may be available), see [Web].

Paralytics are recommended to be administered as straight drug. This provides consistency between operating room and the ICU, and eliminates potential compounding errors.

dosing units differ from concentration units

Dosage

Available as rocuronium bromide; dosage expressed in terms of the salt.

Adjust dosage carefully according to individual requirements and response.

Pediatric Patients

Skeletal Muscle Relaxation

Initial (Intubating) Dose

IV

Initial dose of 0.6 mg/kg recommended. A lower dose of 0.45 mg/kg may be used depending on anesthetic technique and patient age.

When used concomitantly with halothane anesthesia, a dose of 0.6 mg/kg generally produces good to excellent intubating conditions within 60 seconds. (See Onset and also Duration under Pharmacokinetics.)

When used concomitantly with sevoflurane (induction) and isoflurane/nitrous oxide (maintenance) anesthesia, a dose of 0.45 or 0.6 mg/kg generally produces good to excellent intubating conditions within 75 seconds. (See Onset and also Duration under Pharmacokinetics.)

Maintenance Dosage

More frequent administration of maintenance doses may be required in children 1–12 years of age compared with adults.

Intermittent IV Injection

Children 3 months of age through adolescence receiving halothane anesthesia: May administer additional doses of 0.075–0.125 mg/kg upon return of first twitch response (T1) to 25%; doses within this range expected to provide clinically sufficient neuromuscular blockade for about 7–10 minutes.

Children of any age receiving sevoflurane and isoflurane/nitrous oxide anesthesia: May administer additional doses of 0.15 mg/kg at reappearance of T3.

Continuous IV Infusion

Children 3 months of age through adolescence receiving halothane anesthesia: May initiate continuous IV infusion at a rate of 12 mcg/kg per minute upon return of T1 to 10% (i.e., one twitch present in a train-of-four [TOF]).

Children of any age receiving sevoflurane and isoflurane/nitrous oxide anesthesia: May initiate continuous IV infusion at a rate of 7–10 mcg/kg per minute at reappearance of T2.

Adults

Skeletal Muscle Relaxation

Initial (Intubating) Dose

IV

0.6 mg/kg. Following administration of this dose, most patients can be intubated within 1–2 minutes. (See Onset and also Duration under Pharmacokinetics.)

May use lower initial dose of 0.45 mg/kg, which can provide sufficient neuromuscular blockade for intubation in about 1.3 minutes. Spontaneous recovery may occur more rapidly with lower initial dose.

If a larger initial dose is necessary, 0.9 or 1.2 mg/kg may be administered. (See Onset and also Duration under Pharmacokinetics.)

Rapid Sequence Intubation

IV

0.6–1.2 mg/kg. Good to excellent intubating conditions can be expected in <2 minutes in appropriately premedicated and adequately anesthetized patients.

Maintenance Dosage

Intermittent IV Injection

Additional doses of 0.1, 0.15, or 0.2 mg/kg to provide clinically sufficient neuromuscular blockade for about 12, 17, or 24 minutes, respectively, when used concomitantly with balanced anesthesia. (See Duration under Pharmacokinetics.)

Initiate intermittent maintenance doses once neuromuscular blockade has returned to 25% of control T1 (i.e., 3 twitches in a TOF).

Continuous IV Infusion

Manufacturer recommends initial rate of 10–12 mcg/kg per minute. Individualize infusion rate based on patient response to peripheral nerve stimulation; in clinical studies, 4–16 mcg/kg per minute usually was required.

Initiate continuous IV infusion only after early spontaneous recovery from initial IV dose is evident. Additional direct IV (“bolus”) doses may be necessary to maintain adequate neuromuscular blockade if the infusion is initiated after substantial return of neuromuscular function (>10% of control).

May need to reduce infusion rate by about 30–50% approximately 45–60 minutes following the initial IV dose if steady-state anesthesia has been induced with enflurane or isoflurane.

Special Populations

Hepatic Impairment

Increased initial dose may be required for rapid sequence induction to achieve effective neuromuscular blockade (however, doses >0.6 mg/kg have not been evaluated); once blockade is established, duration may be prolonged. (See Hepatic Impairment under Cautions.)

Renal Impairment

Dosage adjustments not required; individualize dosage. (See Renal Impairment under Cautions.)

Geriatric Patients

Manufacturer makes no dosage recommendations. (See Geriatric Use under Cautions.)

Burn Patients

Substantially increased doses may be required due to development of resistance. (See Burn Patients under Cautions.)

Patients with Impaired Circulation

Onset time may be delayed; however, larger than usual doses generally not recommended. When feasible, allow more time for rocuronium to achieve its effect.

Obese Patients

Base dosage on actual body weight.

Patients with Neuromuscular Disease

Administer small test dose; monitor degree of neuromuscular blockade with a peripheral nerve stimulator to determine dosage requirements. (See Neuromuscular Diseases under Cautions.)

Cautions for Rocuronium Bromide

Contraindications

• Known hypersensitivity to rocuronium bromide or any ingredient in the formulation.

Warnings/Precautions

Warnings

Administration Precautions

Because of the potential for severely compromised respiratory function and other complications, take special precautions during administration. (See Boxed Warning and also see General under Dosage and Administration.)

Sensitivity Reactions

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, reported rarely. Potential for cross-sensitivity with other neuromuscular blocking agents (both depolarizing and nondepolarizing).

Take appropriate precautions; emergency treatment for anaphylaxis should be immediately available.

General Precautions

Burn Patients

Resistance to therapy with neuromuscular blocking agents can develop in burn patients, particularly those with burns over 25–30% or more of body surface area.

Resistance generally becomes apparent ≥1 week after the burn, peaks ≥2 weeks after the burn, persists for several months or longer, and decreases gradually with healing.

Consider possible need for substantially increased doses.

Neuromuscular Diseases

Possible profound neuromuscular blockade in patients with neuromuscular diseases (e.g., myasthenia gravis, Eaton-Lambert syndrome).

Administer small test dose; monitor degree of neuromuscular blockade with a peripheral nerve stimulator.

Conditions that May Potentiate or Cause Resistance to Neuromuscular Blocking Agents

Neuromuscular blockade may be potentiated in patients with debilitation, cachexia, or carcinomatosis or in those receiving certain concomitant drugs (e.g., enflurane, isoflurane, antibiotics, magnesium salts, lithium, local anesthetics, procainamide, quinidine). A reduction in rocuronium dosage may be required.

Conditions that may cause resistance to nondepolarizing neuromuscular blocking agents include burns, disuse atrophy, denervation, direct muscle trauma, and long-term use of carbamazepine, phenytoin, or neuromuscular blocking agents. An increase in rocuronium dosage may be required.

Cardiovascular Effects

Possible increased pulmonary vascular resistance; use with caution in patients with pulmonary hypertension or valvular heart disease.

Patients with conditions that prolong circulation time (e.g., cardiovascular disease) may experience a delay in onset time of rocuronium.

Intensive Care Setting

Possible prolonged paralysis and/or muscle weakness or myopathy with long-term use of neuromuscular blocking agents in the ICU.

Continuous monitoring of neuromuscular transmission recommended during neuromuscular blocking agent therapy in intensive care setting. Do not administer additional doses before there is a definite response to nerve stimulation tests.

Residual Paralysis

Residual neuromuscular blockade can occur as a result of drug (or metabolite) accumulation or concomitant use of certain drugs. Consider use of a reversal agent. (See Reversal of Neuromuscular Blockade under Dosage and Administration.)

Extubate patients only when adequate recovery of neuromuscular function is assured.

Electrolyte Disturbances

Possible increased or decreased neuromuscular blockade in patients with electrolyte disturbances (e.g., diarrhea, adrenocortical insufficiency) or acid/base imbalances.

QT Interval Prolongation

Prolongation of the QT interval reported in pediatric patients receiving rocuronium and general anesthetics concomitantly.

Malignant Hyperthermia

Malignant hyperthermia is rarely associated with use of neuromuscular blocking agents and/or potent inhalation anesthetics. Be vigilant for its possible development and prepared for its management in any patient undergoing general anesthesia.

Rocuronium has not been evaluated in patients susceptible to malignant hyperthermia.

Local Effects

Possible local irritation; discontinue injection and restart in another vein if extravasation occurs.

Specific Populations

Pregnancy

Category C.

Possible poor or inadequate intubating conditions following rapid sequence induction in cesarean section patients; use not recommended for rapid sequence induction in such patients.

Lactation

Not known whether rocuronium is distributed into milk.

Pediatric Use

Has been evaluated in pediatric patients of all ages, including neonates, under sevoflurane and isoflurane/nitrous oxide anesthesia, and children 3 months to 14 years of age under halothane anesthesia.

Manufacturer states that rocuronium is not recommended for rapid sequence intubation in pediatric patients.

Geriatric Use

Slightly slower onset and slightly increased duration of neuromuscular blockade; however, recovery time in patients ≥65 years of age does not appear to differ from that in younger adults.

Hepatic Impairment

Possible incomplete neuromuscular blockade; increased initial dosage may be required. See Hepatic Impairment under Dosage and Administration.

Use with caution. Possible increase in half-life, duration of neuromuscular blockade, and recovery time. (See Special Populations under Absorption and also under Elimination, in Pharmacokinetics.)

Renal Impairment

No substantial differences in pharmacokinetic profile relative to patients without renal impairment. (See Absorption: Special Populations, under Pharmacokinetics.)

Common Adverse Effects

Transient hypotension and hypertension.

Drug Interactions

Specific Drugs

Rocuronium Bromide Pharmacokinetics

Absorption

Bioavailability

Poorly absorbed from the GI tract.

Onset

Onset of action is slower than that of succinylcholine but more rapid than that of most other currently available nondepolarizing agents.

Onset of neuromuscular blockade is more rapid in pediatric patients than adults.

Following IV administration of 0.45 or 0.6 mg/kg in adults, neuromuscular blockade is clinically sufficient in about 1.3 (range 0.8–6.2) or 1 (range: 0.4–6) minute, respectively, and is maximal in <4 or <3 minutes, respectively.

Maximum neuromuscular blockade generally occurs within 1 minute in children 3 months to 12 years of age.

Duration

Following initial dose of 0.45 or 0.6 mg/kg under balanced anesthesia in adults, clinically sufficient neuromuscular blockade persists for about 22 (range: 12–31) or 31 (range: 15–85) minutes, respectively. Following initial adult dose of 0.9 or 1.2 mg/kg, clinically sufficient neuromuscular blockade persists for about 58 (range: 27–111) or 67 (range: 38–160) minutes, respectively.

Following initial dose of 0.6 mg/kg under halothane anesthesia in children 3–12 months of age or >1–12 years of age, clinically sufficient neuromuscular blockade generally persists for about 41 (range: 24–68) or 26 (range: 17–39) minutes, respectively.

Following maintenance doses of 0.1, 0.15, or 0.2 mg/kg in adults receiving balanced anesthesia, clinically sufficient neuromuscular blockade persists for about 12 (range: 2–31), 17 (range: 6–50), or 24 (range: 7–69) minutes, respectively.

Following maintenance doses of 0.075–0.125 mg/kg in children, clinically sufficient neuromuscular blockade persists for 7–10 minutes.

The time necessary for 25–75% recovery from neuromuscular blockade in adults is about 13 minutes.

Spontaneous recovery from neuromuscular blockade in children 3–12 months of age generally proceeds at a rate comparable to that in adults; recovery is more rapid in children 1–12 years of age.

Special Populations

In patients with hepatic impairment, prolonged duration of neuromuscular blockade.

In patients with renal failure, no substantial change in onset or duration of neuromuscular blockade; however, interindividual variation in duration may be greater.

In geriatric patients, slightly slower onset and slightly prolonged duration of neuromuscular blockade.

Distribution

Plasma Protein Binding

About 30%.

Special Populations

In patients with hepatic impairment, increased volume of distribution.

Elimination

Metabolism

Metabolized to a less active metabolite, 17-desacetyl-rocuronium.

Elimination Route

Eliminated primarily by the liver.

Half-life

Triphasic; terminal half-life is 1.4 or 2.4 hours during balanced anesthesia or isoflurane anesthesia, respectively.

Special Populations

In patients with hepatic impairment, terminal half-life is 4.3 hours during isoflurane anesthesia.

Stability

Storage

Parenteral

Injection

2–8°C; do not freeze. May store at room temperature for ≤60 days; use opened vials within 30 days.

Following dilution to final concentration of ≤5 mg/mL in 5% dextrose, 0.9% sodium chloride, 5% dextrose and 0.9% sodium chloride, lactated Ringer's, or sterile water for injection, stable for ≤24 hours at room temperature.

Actions

• Produces skeletal muscle relaxation by causing a decreased response to acetylcholine (ACh) at the myoneural (neuromuscular) junction of skeletal muscle.

• Exhibits high affinity for ACh receptor sites and competitively blocks access of ACh to motor end-plate of myoneural junction; may affect ACh release.

• Blocks the effects of both the small quantities of ACh that maintain muscle tone and the large quantities of ACh that produce voluntary skeletal muscle contraction; does not alter the resting electrical potential of the motor end-plate or cause muscular contractions.

• Appears to have little, if any, histamine-releasing activity.

Advice to Patients

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., cardiovascular disease, neuromuscular disease).

• Importance of informing patients of other important precautionary information. (See Cautions.)

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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