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10 x 4 mg
50 x 4 mg
Like other neuromuscular blocking agents, Norcuron should only be administered by, nor under supervision of, experienced clinicians who are familiar with the action and use of these drugs. Like with all other neuromuscular blocking agents, the dosage of Norcuron should be
individualised in each patient. The anaesthetic method used, the expected duration of surgery, the possible interaction with other drugs that are administered before or during anaesthesia 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 to monitor neuromuscular block and recovery. Inhalation anesthetics do potentiate the neuromuscular blocking effects of Norcuron. This presentation however, becomes clinically relevant in the course of anesthesia, when the volatile agents have reached the tissue concentrations required for this interaction. Consequently, adjustments with Norcuron should be made by administering smaller maintenance doses at less frequent intervals or by using lower infusion rates of Norcuron during long lasting procedures (longer than 1 hour) under inhalational anesthesia. In adults patients the following dosage recommendations may severe as a general guideline for tracheal intubation and muscle relaxation for short to long lasting
surgical procedures. Tracheal intubation: The standard intubating dose during routine anesthesia is 0.08 to 0.1mg vecuronium bromide per kg body weight, after which adequate intubation conditions are established within 90 to 120 seconds in nearly all patients. Dosages of Norcuron for surgical procedures after intubation with suxamethonium: 0,03 to 0,05 mg vecuronium bromide per kg body weight.
If suxamethonium is used for intubation, the administration of Norcuron should be delayed until the patient has clinically recovered from the neuromuscular block induced by suxamethonium.
Maintenance dosing: The recommended maintenance dose is: 0,02 to 0,03 mg vecuronium bromide per kg body weight. These maintenance doses should best be given when twitch height has recovered to 25 % of control twitch height.
Adjunct to general anesthesia to facilitate tracheal intubation and to provide sheletal muscle relaxation during surgery.
Hypersensitivity to vecuronium or the bromide ion or to any of the excipients of Norcuron.
Since Norcuron causes paralysis of the respiratory muscles, ventilatory support is mandatory for patients treated with this drug until adequate spontaneous respiration is restored. As with other neuromuscular blocking agents, residual curarization has been reported for Norcuron. In order to prevent complications 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 morelikely to occur. Anaphylactic reactions can occur following the administration of neuromuscular blocking agents. Precautions for treating such reactions should always be taken. Particularly in the case of previous anaphylactic reactions to muscle relaxants, special precautions should be taken since allergic cross- reactivity to muscle relaxants has been reported. Since Norcuron has no cardiovascular effects within the clinical dosage range, it does not attenuate bradycardia that may occur due to the use of some types of
anaesthetics and opiates or due to vagal reflexes during surgery. Therefore, reassessment of the use and/or dosage of vagolytic drugs such as atropine for premedication or at induction of anaesthesia, may be of value for surgical procedures during which vagal reactions are more likely to occur (e.g. surgical procedures where anaesthetic drugs with known vagal stimulatory effects are used, ophthalmic, abdominal or anorectal surgery, etc.). Presently there are insufficient data to give recommendations for the use of Norcuron in the Intensive Care Unit. As with other muscle relaxants prolonged neuromuscular block following long term use of Norcuron in seriously ill patients in the Intensive
Care Unit has been reported. It is essential that during continuous neuromuscular block patients receive adequate analgesia and sedation and that neuromuscular transmission is monitored throughout; furthermore, muscle relaxants should be administered in carefully adjusted doses, sufficient for the maintenance of less than complete block by or under the supervision of experienced clinicians who are familiar
with its actions and with appropriate neuromuscular monitoring techniques
The following conditions may influence the pharmacokinetics and/or pharmacodynamics of Norcuron:
Hepatic and/or biliary tract disease and renal failure. Because vecuronium is excreted in bile and in urine, Norcuron should be used with caution in patients with clinically significant hepatic and/or biliary disease and/or renal failure. In these patient groups prolongation of action has been observed, especially when high doses of vecuronium (0.15-0.2 mg/kg bodyweight) were administered in
patients with hepatic disease.
Prolonged circulation time Conditions associated with prolonged circulation time such as cardiovascular disease, old age, oedematous state resulting in an increased volume of distribution, may contribute to an increase in the onset time of neuromuscular block. The duration
of action may also be prolonged due to a reduced plasma clearance.
Neuromuscular disease As with other neuromuscular blocking agents, Norcuron should be used with extreme caution in patients with 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 the myasthenic (Eaton Lambert) syndrome, small doses of Norcuron may have profound effects and Norcuron should be titrated to the response.
Hypothermia In operations under hypothermia, the neuromuscular blocking effect of Norcuron is increased and the duration is prolonged.
Obesity Like other neuromuscular blocking agents, Norcuron may exibit a prolonged duration and a prolonged spontaneous recovery in obese patients, when the administration doses are calculated on actual body weight.
Burns Patients with burns are known to develop resistance to non- depolarizing agents. It is recommended that the dose is titrated to response. Conditions which may increase the effects of Norcuron are : Hypokalaemia (e.g. after severe vomiting, diarrhoea, and diuretic therapy), hypermagnesaemia, hypocalcaemia (after massive transfusions), hypoproteinaemia, dehydration, acidosis, hypercapnoea, cachexia. Severe electrolyte disturbances, altered blood pH or dehydration should therefore be corrected when possible.
Prolonged Neuromuscular block The most frequent adverse reaction to nondepolarizing blocking agents as a class consists of an extension of the drug’s pharmacological action beyond the time period needed. This may vary from skeletal muscle weakness to profound and prolonged skeletal muscle paralysis resulting in respiratory insufficiency or apnea. A few cases of myopathy have been reported after Norcuron was used in the ICU in combination with corticosteroids.
Anaphylactic reactions Although very rare, severe anaphylactic reactions to neuromuscular blocking agents, including Norcuron, have been reported. Anaphylactic/ anaphylactoid reactions usually comprise of several signs or symptoms, e.g. : bronchospasm, cardiovascular
changes (e.g. hypotension, tachycardia, circulatory collapse- shock), and cutaneous changes (e.g. angioedema, urticaria). These reactions have, in some cases, been fatal. Due to the possible severity of these reactions, one should always assume they may occur and take the necessary precautions.
Histamine release and histaminoid reactions Since neuromuscular blocking agents are known to be capable of inducing histamine
release both locally and systemically, the possible occurrence of itching and erythematous reactions at the site of injection and/or generalised histaminoid (anaphylactoid) reactions such as bronchospasm and cardiovascular changes should always be taken into consideration when administering these drugs. Experimental studies with intradermal injection of Norcuron have demonstrated that this drug has only a weak capacity for inducing local histamine release. Controlled studies in man failed to demonstrate any significant rise in plasma histamine levels after intravenous administration of Norcuron. Still, such cases have rarely been reported during large scale use of Norcuron.
For full details see prescribing information.
The following drugs have been shown to influence the magnitude and/or duration of action of non-depolarizing neuromuscular blocking agents:
Effect of other drugs on Norcuron Halogenated volatile anesthetics potentiate the neuromuscular block of Norcuron. The effect only becomes apparent with maintenance dosing. Reversal of the block with anticholinesterase inhibitors could also be inhibited.
After intubation with Suxamethonium . Long term concomitant use of corticosteroids and Norcuron in the ICU may result in prolonged duration of neuromuscular block or myopathy
– antibiotics: aminoglycoside, lincosamide and polypeptide antibiotics, acylaminopenicillin antibiotics, high doses of metronidazole
– diuretics, quinidine, magnesium salts, calcium channel blocking agents, lithium salts, cimetidine, lidocaine and acute administration of phenytoin or ß-blocking agents. MAO inhibiting agents, protamine, α-adrenergic blocking agents Recurarization has been reported after post- operative administration of: aminoglycosides, lincosdamide, polypeptide and acylamino-penicillin antibiotics, quinidine and magnesium salts.
Pregnancy and Lactation
There are insufficient data on the use of Norcuron during animal or human pregnancy to assess potential harm to the foetus. Norcuron should be given to a pregnant woman only when the attending physician decides that the benefits outweigh the risks.
Caesarean section Studies with Norcuron, administered in doses up to 0,1 mg/kg, have shown its safety for use in caesarean section. In caesarean section the dose should not exceed 0.1 mg/kg. In several clinical studies Norcuron did not affect Apgar score, fetal muscle tonus nor cardiorespiratory adaptation. From umbilical cord blood sampling it is apparent that only very little placental transfer of Norcuron does occur which did not lead to the observation of any clinical adverse effect in the new-born.
Note: Reversal of Norcuron-induced neuromuscular block may be unsatisfactory in patients receiving magnesium sulphate for toxemia of pregnancy because magnesium salts enhance neuromuscular block. Therefore, in patients receiving magnesium sulphate, the dosage of Norcuron should be reduced and be carefully titrated to twitch response.
Lactation There are no human data on the use of Norcuron during lactation. Norcuron should b given to lactating women only when the attending physician decides that the benefits outweigh the risks.
In the event of overdose and prolonged neuromuscular block, the patient should continue to receive ventilatory support and sedation. Upon start of spontaneous recovery an acetylcholinesterase inhiborts (e.g. neostigmine, edrophonium, pyridostigmine) should be administered in adequate doses. When administration of a cholinesterase inhibiting agent fails to reverse the neuromuscular effects of Norcuron, ventilation must be continued until spontaneous breathing is restored. Repeated dosage of a cholinesterase inhibitor can be dangerous.