Rocuronium is indicated:
Rocuronium is a non-depolarizing neuromuscular blocking agent that works by competitively binding to nicotinic acetylcholine receptors at the motor end-plate. By blocking these receptors, it prevents acetylcholine from binding, thereby inhibiting depolarization of the muscle membrane. As a result, calcium release is prevented and muscle contraction does not occur, leading to muscle relaxation. This neuromuscular blockade can be reversed by acetylcholinesterase inhibitors such as neostigmine and edrophonium, which increase the availability of acetylcholine. Additionally, non-depolarizing agents like rocuronium may also interfere with sodium and potassium ion movement across the membrane, further preventing nerve signal transmission and muscle contraction.
Dosage: Like other neuromuscular blocking agents, Rocuronium should only be administered by, or under supervision of, experienced clinicians who are familiar with the action and use of these agents. The dosage of Rocuronium should be individualized in each patient. The method of anaesthesia and the expected duration of surgery, the method of sedation and the expected duration of mechanical ventilation, the possible interaction with other medicines that are administered concomitantly and the condition of the patient should be taken into account when determining the dose. The use of an appropriate neuromuscular monitoring technique is recommended for the evaluation of neuromuscular block and recovery. Inhalational anaesthetics do potentiate the neuromuscular blocking effects of Rocuronium. This potentiation, however, becomes clinically relevant in the course of anaesthesia, when the volatile agents have reached the tissue concentrations required for this interaction. Consequently, adjustments with Rocuronium should be made by administering smaller maintenance doses at less frequent intervals or by using lower infusion rates of Rocuronium during lasting procedures (longer than 1 hour) under inhalational anaesthesia. In adult patients the following dosage recommendations may serve as a general guideline for tracheal intubation and muscle relaxation for short to long lasting surgical procedures, and for use in the intensive care unit.
Surgical Procedures: Tracheal Intubation: The standard intubating dose during routine anaesthesia is 0.6 mg Rocuronium Bromide per kg body weight, after which adequate intubation conditions are established within 60 seconds in nearly all patients. A dose of 1.0 mg Rocuronium Bromide per kg body weight is recommended for facilitating tracheal intubation conditions during rapid sequence induction of anaesthesia, after which adequate intubation conditions are also established within 60 seconds in nearly all patients. If a dose of 0.6 mg Rocuronium Bromide per kg body weight is used for rapid sequence induction of anaesthesia, it is recommended to intubate the patient 90 seconds after administration of Rocuronium Bromide. In patients undergoing Caesarean section it is recommended to only use a dose of 0.6 mg Rocuronium Bromide per kg body weight, since a 1.0 mg/kg dose has not been investigated in this patient group.
Maintenance Dosing: The recommended maintenance dose is 0.15 mg Rocuronium Bromide per kg body weight; in the case of long-term inhalational anaesthesia this should be reduced to 0.075–0.1 mg Rocuronium Bromide per kg body weight. The maintenance doses should best be given when twitch height has recovered to 25% of control twitch height, or when 2–3 responses to train of four stimulation are present.
Continuous Infusion: If Rocuronium Bromide is administered by continuous infusion, it is recommended to give a loading dose of 0.6 mg Rocuronium Bromide per kg body weight and, when neuromuscular block starts to recover, to start administration by infusion. The infusion rate should be adjusted to maintain twitch response at 10% of control twitch height, or to maintain 1–2 responses to train of four stimulation. In adults under intravenous anaesthesia, the infusion rate required to maintain neuromuscular block at this level ranges from 0.3–0.6 mg/kg/hr and under inhalational anaesthesia the infusion rate ranges from 0.3–0.4 mg/kg/hr. Continuous monitoring of neuromuscular block is recommended since infusion rate requirements vary from patient to patient and with the anaesthetic method used.
Dosing in Paediatric Patients: Children (1–14 years) and infants (1–12 months) under halothane anaesthesia manifest similar sensitivity to Rocuronium Bromide as adults. Onset of action is faster in infants and children than in adults. Clinical duration is shorter in children than in adults. For continuous infusion in paediatrics, the infusion rates, with exception of children, are the same as for adults. For children higher infusion rates might be necessary. For children the same initial infusion rates as for adults are recommended and this should be adjusted to maintain twitch response at 10% of control twitch height or to maintain 1 or 2 responses to train of four stimulation during the procedure. There are insufficient data to support dose recommendations for the use of Rocuronium Bromide in neonates (0–1 month). The experience with Rocuronium Bromide in rapid sequence induction in paediatric patients is limited. Rocuronium Bromide is therefore not recommended for facilitating tracheal intubation conditions during rapid sequence induction in paediatric patients.
Dosing in Geriatric patients and patients with Hepatic and/or Biliary tract disease and/or Renal Failure: The standard intubation dose for geriatric patients and patients with hepatic and/or biliary tract disease and/or renal failure during routine anaesthesia is 0.6 mg Rocuronium Bromide per kg body weight. A dose of 0.6 mg per kg body weight should also be considered for rapid sequence induction of anaesthesia in patients with a prolonged duration of action is expected. Regardless of the anaesthetic technique used, the recommended maintenance dose for these patients is 0.075–0.1 mg Rocuronium Bromide per kg body weight, and the recommended infusion rate is 0.3–0.4 mg/kg/hr.
Dosing in Overweight and Obese Patients: When used in overweight or obese patients (defined as patients with a body weight of 30% or more above ideal body weight) doses should be reduced taking into account ideal body weight.
Intensive Care Procedures (Tracheal Intubation): For tracheal intubation, the same doses should be used as described above under surgical procedures.
Maintenance Dosing: The use of an initial loading dose of 0.6 mg Rocuronium Bromide per kg body weight is recommended, followed by a continuous infusion as soon as twitch height recovers to 10% or upon reappearance of 1 to 2 twitches to train of four stimulation. Dosage should always be titrated to effect in the individual patient. The recommended initial infusion rate for the maintenance of a neuromuscular block of 80–90% (1 to 2 twitches to TOF stimulation) in adult patients is 0.3–0.6 mg/kg/hr during the first hour of administration, which will need to be decreased during the following 6–12 hours, according to the individual response. Thereafter, individual dose requirements remain relatively constant. A large between patient variability in hourly infusion rates has been found in controlled clinical studies, with mean hourly infusion rates ranging from 0.2–0.5 mg/kg/hr depending on nature and extent of organ failure(s), concomitant medication and individual patient characteristics. To provide optimal individual patient control, monitoring of neuromuscular transmission is strongly recommended. Administration up to 7 days has been investigated.
Special Populations: Rocuronium Bromide is not recommended for the facilitation of mechanical ventilation in the intensive care in paediatric and geriatric patients due to a lack of data on safety and efficacy.
The following agents have been shown to affect the intensity and/or duration of action of non-depolarizing neuromuscular blocking agents:
Effect of other agents on Rocuronium Bromide
Increased Effect: Halogenated volatile anesthetics enhance the neuromuscular blocking effect of Rocuronium Bromide. This potentiation becomes evident mainly during maintenance dosing. Reversal of the block with anticholinesterase agents may also be reduced. Prolonged concurrent use of corticosteroids with Rocuronium Bromide in ICU settings may lead to extended neuromuscular blockade or development of myopathy.
Other drugs:
Recurarization has been reported following postoperative use of aminoglycoside, lincosamide, polypeptide and acylamino-penicillin antibiotics, as well as quinidine, quinine, and magnesium.
Decreased Effect: Long-term prior use of phenytoin or carbamazepine, as well as protease inhibitors (such as gabexate and ulinastatin), may reduce the effect.
Variable Effect: The combined use of other non-depolarizing neuromuscular blocking agents with Rocuronium Bromide may either enhance or reduce the neuromuscular block, depending on the sequence of administration and the specific agent used. Administration of suxamethonium after Rocuronium Bromide may also result in either potentiation or attenuation of its neuromuscular blocking effect.
Effect of Rocuronium Bromide on other drugs: Concomitant use of Rocuronium Bromide with lidocaine may accelerate the onset of action of lidocaine.
Rocuronium is contraindicated in patients with hypersensitivity to rocuronium, bromide ions, or any component of the formulation.
In clinical trials, the most common adverse reactions (≥2%) were transient hypotension and hypertension. Other reported adverse reactions include:
Although very rare, severe anaphylactic reactions have been reported with neuromuscular blocking agents, including Rocuronium Bromide. These anaphylactic or anaphylactoid reactions may include bronchospasm, cardiovascular changes (such as hypotension, tachycardia, or circulatory collapse/shock), and cutaneous manifestations (such as angioedema and urticaria). In some cases, these reactions have been fatal. Due to their potential severity, appropriate precautions should always be taken.
Neuromuscular blocking agents are known to cause histamine release both locally at the injection site and systemically. Therefore, the possibility of itching and erythematous reactions at the injection site and/or generalized histaminoid (anaphylactoid) reactions (see also Anaphylactic Reactions above) should always be considered. Clinical studies have shown only a slight increase in mean plasma histamine levels following rapid bolus administration of 0.3–0.9 mg/kg Rocuronium Bromide.
Prolonged neuromuscular block: The most common adverse effect of nondepolarizing neuromuscular blocking agents is prolongation of their pharmacological action beyond the required duration. This may range from skeletal muscle weakness to severe and prolonged paralysis, resulting in respiratory insufficiency or apnea.
Myopathy: Myopathy has been reported following the use of various neuromuscular blocking agents in ICU settings, particularly when used together with corticosteroids.
Local injection site reactions: During rapid sequence induction of anesthesia, pain at the injection site has been reported, especially when the patient has not completely lost consciousness and particularly when propofol is used as the induction agent. Clinical studies have shown that injection pain occurred in 16% of patients receiving propofol for rapid sequence induction and in less than 0.5% of patients receiving fentanyl and thiopental.
Pregnancy: There are no adequate clinical data regarding the use of Rocuronium Bromide in pregnant women. Animal studies have not demonstrated any direct or indirect harmful effects on pregnancy, fetal development, delivery, or postnatal growth. However, caution should be exercised when administering Rocuronium Bromide during pregnancy.
Caesarean section: Rocuronium Bromide may be used during Caesarean section as part of rapid sequence induction, provided intubation difficulties are not anticipated and adequate anesthesia is ensured, or following intubation facilitated by suxamethonium. A dose of 0.6 mg/kg has been shown to be safe in pregnant women undergoing Caesarean section. It does not adversely affect Apgar score, fetal muscle tone, or cardio-respiratory adaptation. Only minimal placental transfer occurs, and no clinically significant effects have been observed in newborns.
Lactation:It is not known whether Rocuronium Bromide is excreted in human breast milk. Animal studies indicate only minimal excretion into milk. Rocuronium Bromide should be used in breastfeeding women only if the potential benefit outweighs the possible risk.
Instructions for use/handling: Compatibility has been evaluated with several infusion fluids. At nominal concentrations of 0.5 mg/mL and 2.0 mg/mL, Rocuronium Bromide is compatible with 0.9% NaCl, 5% dextrose, 5% dextrose in saline, sterile water for injection, Lactated Ringer’s solution, and Haemaccel. Administration should begin immediately after preparation and must be completed within 24 hours. Any remaining solution should be discarded.
For use/handling: When Rocuronium Bromide is administered through the same infusion line as other medications, the line must be thoroughly flushed (e.g., with 0.9% NaCl) between administrations. This is especially important for drugs known to be incompatible with Rocuronium Bromide or those for which compatibility has not been confirmed.
For use/handling: If administered through the same infusion line as other drugs, the line should be adequately flushed (e.g. with 0.9% NaCl) before and after administration to avoid incompatibility with other medicines.
In case of overdose with prolonged neuromuscular blockade, the patient must be maintained on ventilatory support along with adequate sedation. Two options are available for reversing the neuromuscular block. Sugammadex may be used to reverse profound or deep blockade, with the dose depending on the degree of neuromuscular block.
Alternatively, an acetylcholinesterase inhibitor such as neostigmine, edrophonium, or pyridostigmine, in combination with an appropriate vagolytic agent like atropine, may be administered when T2 reappears or at the first signs of clinical recovery, ensuring proper dosing.
If acetylcholinesterase inhibitors fail to reverse the effects of Rocuronium Bromide, assisted ventilation must be continued until spontaneous respiration is restored. Repeated administration of these inhibitors may be hazardous.
Non-depolarizing muscle relaxants
Rocuronium Bromide should be stored in a refrigerator at 2–8°C and must not be frozen
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