Rocuronium Bromide

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• AMIKACIN/ROCURONIUM BROMIDE
• GENTAMICIN/ROCURONIUM BROMIDE
• KANAMYCIN/ROCURONIUM BROMIDE
• NEOMYCIN/ROCURONIUM BROMIDE
• NETILMICIN/ROCURONIUM BROMIDE
• ROCURONIUM BROMIDE/STREPTOMYCIN
• ROCURONIUM BROMIDE/TOBRAMYCIN

This is not a complete list of Rocuronium Bromidedrug interactions. Ask your doctor or pharmacist for more information.

Nondepolarizing neuromuscular blocking agent.1 9

Contraindications

• Known hypersensitivity to rocuronium bromide or any ingredient in the formulation.1

Warnings/Precautions

Warnings

Potential for severely compromised respiratory function and respiratory paralysis.a

Should be used only by individuals experienced in the use of neuromuscular blocking agents and in the maintenance of an adequate airway and respiratory support.1 Facilities and personnel necessary for intubation, administration of oxygen, and assisted or controlled respiration should be immediately available.1

IV cholinesterase inhibitor (e.g., neostigmine, pyridostigmine, edrophonium) should be readily available.1 (See Reversal of Neuromuscular Blockade under Dosage and Administration.)

Use with caution in patients with pulmonary impairment or respiratory depression.a

Possible profound neuromuscular blockade in patients with neuromuscular disease (e.g., myasthenia gravis, Eaton-Lambert syndrome).1

Administer small test dose; monitor degree of neuromuscular blockade with a peripheral nerve stimulator.1

Sensitivity Reactions

Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, reported.1

Caution in patients with a history of anaphylactic reaction to other neuromuscular blocking agents; potential for cross-sensitivity.1

General Precautions

Resistance to therapy with neuromuscular blocking agents can develop in burn patients,1 particularly those with burns over 25–30% or more of body surface area.a

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

Consider possible need for substantially increased doses.a

Histamine release or adverse effects associated with histamine release (e.g., bronchospasm, urticaria, flushing) reported rarely.1

Possible increased pulmonary vascular resistance; use with caution in patients with pulmonary hypertension or valvular heart disease.1

Possible development of tolerance to neuromuscular blocking agent therapy.1 Possible prolonged paralysis and/or muscle weakness and atrophy.1

Continuous monitoring of neuromuscular transmission recommended during neuromuscular blocking agent therapy in intensive care setting.1 Do not administer additional doses before there is a definite response to nerve stimulation tests.1

Possible delayed onset of action in patients with impaired circulation (e.g., cardiovascular disease).1 Larger-than-usual initial doses generally are not recommended; when feasible, allow additional time for onset of clinically sufficient neuromuscular blockade.1

Possible increased or decreased neuromuscular blockade in patients with electrolyte disturbances (e.g., diarrhea, adrenocortical insufficiency) or acid/base imbalances.1 a

Malignant hyperthermia is rarely associated with use of neuromuscular blocking agents and/or potent inhalation anesthetics.a Be vigilant for its possible development and prepared for its management in any patient undergoing general anesthesia.1

Rocuronium has not been evaluated in patients susceptible to malignant hyperthermia.1

Possible local irritation; discontinue injection and restart in another vein if extravasation occurs.1

Specific Populations

Category C.1

Possible poor or inadequate intubating conditions following rapid sequence induction in cesarean section patients; use not recommended for rapid sequence induction in such patients.1

Not known whether rocuronium is distributed into milk.1

Safety and efficacy not established in children <3 months of age or >14 years of age.1

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.1

Possible incomplete neuromuscular blockade; increased initial dosage may be required.1 See Hepatic Impairment under Dosage and Administration.

Use with caution.1 Possible increase in half-life, duration of neuromuscular blockade, and recovery time.1 (See Special Populations under Absorption and also under Elimination, in Pharmacokinetics.)

No substantial differences in pharmacokinetic profile relative to patients without renal impairment.1 (See Absorption: Special Populations, under Pharmacokinetics.)

Common Adverse Effects

Skeletal muscle weakness.a

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

• Exhibits high affinity for ACh receptor sites and competitively blocks access of ACh to motor end-plate of myoneural junction; may affect ACh release.1 a

• 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.a

• Appears to have little, if any, histamine-releasing activity.1 a

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• 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).1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

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.