Rocuronium bromide (NDC 0409-9558-05 and 0409-9558-10) Highlights

Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. (1)

To be administered only by experienced clinicians or adequately trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents. (2.1)

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Individualize the dose for each patient. (2.1)

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Peripheral nerve stimulator recommended for determination of drug response and need for additional doses, and to evaluate recovery. (2.1)

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Store rocuronium bromide with cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product. (2.1)

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Tracheal intubation: Recommended initial dose is 0.6 mg/kg. (2.2)

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Rapid sequence intubation: 0.6 to 1.2 mg/kg. (2.3)

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Maintenance doses: Guided by response to prior dose, not administered until recovery is evident. (2.4)

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Continuous infusion: Initial rate of 10 to 12 mcg/kg/min. Start only after early evidence of spontaneous recovery from an intubating dose. (2.5)

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5 mL multiple dose vials containing 50 mg rocuronium bromide injection (10 mg/mL). (3)

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10 mL multiple dose vials containing 100 mg rocuronium bromide injection (10 mg/mL). (3)

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Hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents. (4)

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Appropriate Administration and Monitoring: Use only if facilities for intubation, mechanical ventilation, oxygen therapy, and an antagonist are immediately available. (5.1)

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Anaphylaxis: Severe anaphylaxis has been reported. Consider cross-reactivity among neuromuscular blocking agents. (5.2)

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Risk of Death due to Medication Errors: Accidental administration can cause death. (5.3)

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Need for Adequate Anesthesia: Must be accompanied by adequate anesthesia or sedation. (5.4)

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Residual Paralysis: Consider using a reversal agent in cases where residual paralysis is more likely to occur. (5.5)

Most common adverse reactions (2%) are transient hypotension and hypertension. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or electronically at ProductComplaintsPP@hospira.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Succinylcholine: Use before succinylcholine has not been studied. (7.11)

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Nondepolarizing muscle relaxants: Interactions have been observed. (7.7)

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Enhanced rocuronium bromide injection activity possible: Inhalation anesthetics (7.3), certain antibiotics (7.1), quinidine (7.10), magnesium (7.6), lithium (7.4), local anesthetics (7.5), procainamide (7.8)

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Reduced rocuronium bromide injection activity possible: Anticonvulsants. (7.2)

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Labor and Delivery: Not recommended for rapid sequence induction in patients undergoing Cesarean section. (8.2)

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Pediatric Use: Onset time and duration will vary with dose, age, and anesthetic technique. Not recommended for rapid sequence intubation in pediatric patients. (8.4)