Rocuronium bromide should be administered only by an experienced staff familiar with the use of neuromuscular blocking agents. Adequate facilities and staff for endotracheal intubation and artificial ventilation have to be available for immediate use.
Since rocuronium bromide causes paralysis of the respiratory muscles, ventilatory support is mandatory for patients treated with this active substance until adequate spontaneous respiration is restored. As with all neuromuscular blocking agents, it is important to anticipate intubation difficulties, particularly when used as part of a rapid sequence induction technique.
As with other neuromuscular blocking agents, residual curarization has been reported for Rocuronium. In order to prevent complications resulting from residual curarization, it is recommended to extubate only after the patient has recovered sufficiently from neuromuscular block. Other factors which could cause residual curarization after extubation in the post-operative phase (such as drug interactions or patient condition) should also be considered. If not used as part of standard clinical practice, the use of a reversal agent should be considered, especially in those cases where residual curarization is more likely to occur.
It is essential to ensure that the patient is breathing spontaneously, deeply and regularly before leaving the theatre after anaesthesia.
Anaphylactic reactions (see previously mentioned) can occur after the administration of neuromuscular blocking agents. Precautions for treating such reactions should always be taken. Particularly in the case of previous anaphylactic reactions to neuromuscular blocking agents, special precautions should be taken since allergic cross-reactivity to neuromuscular blocking agents has been reported.
Dose levels higher than 0.9 mg rocuronium bromide per kg body weight may increase the heart rate; this effect could counteract the bradycardia produced by other anaesthetic agents or by vagal stimulation.
In general, following long term use of neuromuscular blocking agents in the ICU, prolonged paralysis and/or skeletal muscle weakness has been noted. In order to help preclude possible prolongation of neuromuscular blockage and/or overdose, it is strongly recommended that neuromuscular transmission is monitored throughout the use of neuromuscular blocking agents. In addition, patients should receive adequate analgesia and sedation. Furthermore, muscle relaxants should be titrated to the effect in the individual patient. This should be done by or under the supervision of experienced clinicians who are familiar with the effects and with appropriate neuromuscular monitoring techniques.
Because rocuronium bromide is always used with other agents and because of the possibility of the occurrence of malignant hyperthermia during anaesthesia, even in the absence of known triggering agents, clinicians should be familiar with the early signs, confirmatory diagnosis and treatment of malignant hyperthermia prior to the start of any anaesthesia. In animal studies it was shown that rocuronium bromide is not a triggering factor for malignant hyperthermia.
Myopathy after long term administration of other non-depolarizing neuromuscular blocking agents in the ICU in combination with corticosteroid therapy has been reported regularly. Therefore, for patients receiving both neuromuscular blocking agents and corticosteroids, the period of use of the neuromuscular blocking agent should be limited as much as possible.
Rocuronium should only be administered after full recovery from the neuromuscular blockade caused by suxamethonium.
The following conditions may influence the pharmacokinetics and/or pharmacodynamics of rocuronium bromide: Hepatic and/or biliary tract disease and renal failure: Rocuronium bromide is excreted in urine and bile. Therefore, it should be used with caution in patients with clinically significant hepatic and/or biliary diseases and/or renal failure. In these patient groups prolongation of the effect has been observed with doses of 0.6 mg rocuronium bromide per kg body weight.
Prolonged circulation time: Conditions associated with prolonged circulation time such as cardiovascular diseases, old age and an oedematous state resulting in an increased volume of distribution, may contribute to a slower onset of the effect. The duration of action may also be prolonged due to a reduced plasma clearance.
Neuromuscular disease: Like other neuromuscular blocking agents, rocuronium bromide should be used with extreme caution in patients with a neuromuscular disease or after poliomyelitis since the response to neuromuscular blocking agents may be considerably altered in these cases. The magnitude and direction of this alteration may vary widely. In patients with myasthenia gravis or with the myasthenic (Eaton-Lambert) syndrome, small doses of rocuronium bromide may have profound effects and rocuronium bromide should be titrated to the response.
Hypothermia: In surgery under hypothermic conditions, the neuromuscular blocking effect of rocuronium bromide is increased and the duration prolonged.
Obesity: Like other neuromuscular blocking agents, rocuronium bromide may exhibit a prolonged duration and a prolonged spontaneous recovery in obese patients, when the administered doses are calculated on actual body weight.
Burns: Patients with burns are known to develop resistance to non-depolarizing neuromuscular blocking agents. It is recommended that the dose is titrated to the response.
Conditions which may increase the effects of rocuronium bromide: Hypokalaemia (e.g. after severe vomiting, diarrhoea or diuretic therapy), hypermagnesaemia, hypocalcaemia (after massive transfusions), hypoproteinaemia, dehydration, acidosis, hypercapnia and cachexia.
Severe electrolyte disturbances, altered blood pH or dehydration should therefore be corrected when possible.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium- free'.
Effects on ability to drive and use machines: Since rocuronium bromide is used as an adjunct to general anesthesia, the usual precautionary measures after a general anesthesia should be taken for ambulatory patients.