It(rocuronium bromide) is indicated as an adjunct to general anesthesia to facilitate routine endotracheal intubation or rapid sequence (initiated at 60-90 seconds post-administration) intubation to provide skeletal muscle relaxation during surgery or mechanical ventilation. Rocuronium bromide is a non-depolarizing neuromuscular blocking agent with a rapid to intermediate onset and an intermediate duration of action depending on dose. Geriatrics (> 65 years of age): Lower maintenance doses and infusion rates are recommended as the duration of neuromuscular blockade tends to be longer in the elderly. For details, see DOSAGE AND ADMINISTRATION, Geriatrics. Pediatrics (? 18 years of age): It is indicated for routine adjunct use in all pediatric patients, including term neonates and infants. Caution is advised in selecting the dosage for intubation and maintenance in neonates and infants because of limited controlled safety and efficacy data. ZEMURON? is not recommended for rapid sequence intubation in pediatric patients. For details
Non depolarizing muscle relaxants
Rocuronium acts by competing for cholinergic receptors at the motor end-plate. This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine and edrophonium. Rocuronium acts by competitively binding to nicotinic cholinergic receptors. The binding of vecuronium decreases the opportunity for acetylcholine to bind to the nicotinic receptor at the postjunctional membrane of the myoneural junction. As a result, depolarization is prevented, calcium ions are not released and muscle contraction does not occur. Evidence also suggests that nondepolarizing agents can affect ACh release. It has been hypothesized that nondepolarzing agents bind to postjunctional ("curare") receptors and may therefore interfere with the sodium and potassium flux, which is responsible for depolarization and repolarization of the membranes involved in muscle contraction.
It is administered intravenously either as a bolus injection or as a continuous infusion. Do not use it if solution contains particles or is not clear. Compatibility: Compatibility studies with the following infusion fluids have been performed. In nominal concentrations of 0.5 mg/mL and 2.0 mg/mL ZEMURON? is compatible in solution with: 0.9% Sodium Chloride Injection, USP 5% Dextrose Injection, USP 5% Dextrose and 0.9% Sodium Chloride Injection, USP Sterile Water for Injection, USP Lactated Ringer's Solution Administration should be begun immediately after mixing, and should be completed within 24 hours. Unused solutions should be discarded.
No formal clinical interaction studies have been conducted in adults or in pediatrics with
rocuronium bromide and other drugs commonly used for anesthesia. Based on post-market
clinical studies and experience, the following drugs have been shown to influence the magnitude
and/or duration of action of non-depolarizing neuromuscular blocking agents:
Antibiotics: Antibiotics from several classes may enhance or prolong the neuromuscular
blockade produced by rocuronium regardless of their route of parenteral administration (e.g.
intravenous, intraperitoneal). Antibiotics such as aminoglycoside, lincosamide and polypeptide
antibiotics, acylamino-penicillin antibiotics have been shown to increase the effect of
rocuronium. Residual neuromuscular blockade has been reported after post-operative
administration of: aminoglycoside, lincosamide, polypeptide and acylamino-penicillin
antibiotics.
Anticonvulsants: Prior chronic administration of phenytoin or carbamazepine has been shown
to decrease the effect of rocuronium. Increased effect of rocuronium has been shown with acute
administration of phenytoin.
Corticosteroids: Long-term concomitant use of corticosteroids and ZEMURON® in the ICU
may result in prolonged duration of neuromuscular blockade or myopathy.
Inhalation Anesthetics: Halogenated volatile anesthetics potentiate the neuromuscular blockade
of ZEMURON® during induction and maintenance. Reversal of the blockade with
anticholinesterase inhibitors could also be inhibited.
Local anesthetics: Local anesthetics used during combined regional and general anesthesia have
been shown to increase the duration of the neuromuscular blockade and decrease requirements of
neuromuscular blocking agents. Other drugs: Increased effect of rocuronium has been shown with: acute administration of ßblocking agents, calcium channel blocking agents, diuretics, intravenous lidocaine, magnesium
salts, lithium salts, procainamide, or quinidine and its isomer quinine. Residual neuromuscular
blockade has been reported after post-operative administration of: quinidine, quinine and
magnesium salts.
Other Non-Depolarizing Neuromuscular Blocking Agents: Administration of other nondepolarizing neuromuscular blocking agents in combination with ZEMURON® may produce
attenuation or potentiation of the neuromuscular blockade, depending on the order of
administration and the neuromuscular blocking agent used.
Protease inhibitors: Protease inhibitors (gabexate, ulinastatin) have been shown to decrease the
effect of ZEMURON®. Succinylcholine: If rocuronium bromide is given following administration of succinylcholine, it
should not be given until recovery from succinylcholine has been observed. The median duration
of action of rocuronium bromide 0.6 mg/kg administered after a 1 mg/kg dose of succinylcholine
when T1 returned to 75% of control was 36 minutes (range 14 – 57, n = 12) vs. 28 minutes (17 –
51, n = 12) without succinylcholine.
Succinylcholine given after the administration of ZEMURON® may produce potentiation or
attenuation of the neuromuscular blocking effect of ZEMURON®
It is not recommended to use a small dose of rocuronium bromide before an intubation dose of
succinylcholine to reduce muscle fasciculation produced by succinylcholine.
Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container
Hypotension and hypertension, Anaphylaxis Residual paralysis Myopathy Increased pulmonary vascular resistance
Pregnant Women: For rocuronium bromide, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus,
In the event of overdosage and prolonged neuromuscular block, the patient should continue to receive ventilatory support and sedation. In this situation there are two options for the reversal of neuromuscular block:
Sugammadex can be used for reversal of intense (profound) and deep block. The dose of sugammadex to be administered depends of the level of neuromuscular block.
An acetylcholinesterase inhibitor (e.g. neostigmine, edrophonium, pyridostigmine), with appropriate vagolytic (e.g atropine) can be used at reappearance of T2 or at the first signs of clinical recovery and should be administered in adequate doses. When administration of an acetylcholinesterase inhibiting agent fails to reverse the neuromuscular effects of Rocuronium Bromide, ventilation must be continued until spontaneous breathing is restored. Repeated dosage of an acetylcholinesterase inhibitor can be dangerous.
Rocuronium Bromide should be stored in the refrigerator at 2-8° C and not be frozen.
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