Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands
Vecuronium is indicated as an adjunct to general anaesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery in adults, neonates, infants, children and adolescents.
For instructions on reconstitution of the product before administration, see section 6.6.
As with other neuromuscular blocking agents, vecuronium should only be administered by, or under supervision of, experienced clinicians who are familiar with the action and use of these drugs.
As with all other neuromuscular blocking agents, the dosage of vecuronium 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.
Inhalational anaesthetics potentiate the neuromuscular blocking effects of vecuronium. 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 vecuronium should be made by administering smaller maintenance doses at less frequent intervals or by using lower infusion rates of vecuronium during long lasting procedures (longer than 1 hour) under inhalational anaesthesia (see section 4.5).
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.
The standard intubating dose during routine anaesthesia is 80 to 100 micrograms vecuronium bromide per kg body weight, after which adequate intubation conditions are established within 90 to 120 seconds in nearly all patients.
Recommended doses: 30 to 50 micrograms vecuronium bromide per kg body weight.
If suxamethonium is used for intubation, the administration of vecuronium should be delayed until the patient has clinically recovered from the neuromuscular block induced by suxamethonium.
The recommended maintenance dose is 20 to 30 micrograms vecuronium bromide per kg body weight.
These maintenance doses should best be given when twitch height has recovered to 25% of control twitch height.
If vecuronium is administered by continuous infusion, it is recommended to give a loading dose first (see ‘Tracheal Intubation’) and, when neuromuscular block starts to recover, to start administration of vecuronium by infusion.
The infusion rate should be adjusted to maintain twitch response at 10% of control twitch height or to maintain 1 to 2 responses to train of four stimulation.
In adults, the infusion rate required to maintain neuromuscular block at this level, ranges from 0.8 to 1.4 micrograms vecuronium bromide/kg/min. For neonates and infants see below. Repeat monitoring of neuromuscular block is recommended since infusion rate requirements vary from patient to patient and with the anaesthetic method used.
The same intubation and maintenance doses as for younger adults (80–100 micrograms/kg and 20-30 micrograms/kg, respectively) can be used. However, the duration of action is prolonged in elderly compared to younger subjects due to changes in pharmacokinetic mechanisms. The onset time in elderly is similar to younger adults.
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 an ideal body weight.
Should there be reason for selection of larger doses in individual patients, initial doses ranging from 150 micrograms up to 300 micrograms vecuronium bromide per kg body weight have been administered during surgery both under halothane and neurolept anaesthesia without adverse cardiovascular effects being noted as long as ventilation is properly maintained. The use of these high dosages of vecuronium pharmacodynamically decreases the onset time and increases the duration of action.
In caesarean section (see also section 4.6) and neonatal surgery the dose should not exceed 100 micrograms/kg.
Although there is very little information on dosage in adolescents, it is advised to use the same dose as in adults, based on the physiological development at this age.
Dose requirements in children are higher than for adults and neonates (see “Paediatric population” in section 5.1). However, the same intubation and maintenance doses as for adults (80–100 micrograms/kg and 20-30 micrograms/kg, respectively) are usually sufficient. Since the duration of action is shorter in children, maintenance doses are required more frequently.
Because of the possible variations of the sensitivity of the neuromuscular junction, especially in neonates and probably in infants up to 4 months of age, an initial test dose of 10–20 micrograms vecuronium bromide per kg body weight followed by incremental doses until 90 to 95% depression of twitch response is achieved is recommended. In neonatal surgery the dose should not exceed 100 micrograms/kg.
Dose requirements in older infants (5-23 months) are the same as in adults. However, since the onset time of vecuronium in these patients is considerably shorter than in adults and children, the use of high intubating doses in general is not required for early development of good intubating conditions.
Since the duration of action and recovery time with vecuronium is longer in neonates and infants than in children and adults, maintenance doses are required less frequently (see Paediatric population" in section 5.1).
There are insufficient data to support dose recommendations for the use of vecuronium bromide in preterm newborn infants.
There are insufficient data concerning continuous infusion of vecuronium in paediatric patients, therefore, no dosing recommendations can be made.
Vecuronium should be administered following reconstitution. Vecuronium is administered intravenously either as a bolus injection or as a continuous infusion (see also section 6.6).
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: (1) sugammadex can be used for reversal of intense (profound) and deep block. The dose of sugammadex to be administered depends on the level of neuromuscular block. The use of sugammadex for the purposes of reversal of vercuronium-induced blockade is recommended for use only in the adult population. (2) An acetylcholinesterase inhibitor (e.g. neostigmine, edrophonium, pyridostigmine) can be used once spontaneous recovery starts and should be administered in adequate doses. When administration of a cholinesterase inhibiting agent fails to reverse the neuromuscular effects of vecuronium, ventilation must be continued until spontaneous breathing is restored. Repeated dosage of a cholinesterase inhibitor can be dangerous.
Unopened vial: 18 months.
After first opening: Chemical and physical in-use (i.e. following reconstitution) stability has been demonstrated for 24 hours at 15 to 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C.
Do not store above 25°C.
For storage conditions after first opening of the medicinal product, see section 6.3.
Do not use vecuronium when the solution after reconstitution contains particles or is not clear.
Vecuronium SUN 10 mg powder for solution for injection/infusion is filled in 10 ml colorless tubular glass vial with grey bromobutyl rubber stopper sealed with red flip off aluminium seal.
Vecuronium SUN 10 mg powder for solution for injection/infusion is supplied in packs containing 1, 4, 10 and 20 vials.
Not all pack sizes may be marketed.
Addition of 5ml water for injections results in a solution of pH 4 and osmolality of 200 mOsm/kg containing 2 mg vecuronium bromide per ml (2 mg/ml), each vial contains 10 mg vecuronium bromide which is equivalent to 8.75 mg of vecuronium.
Alternatively, in order to obtain a solution with a lower concentration Vecuronium SUN may be reconstituted with a volume up to 10 ml of the following infusion fluids
When Vecuronium SUN is reconstituted with water for injections, the resultant solution can be mixed with the following infusion fluids, packed in PVC or glass, to a dilution up to 40 mg/litre
The above-mentioned reconstituted solution can also be injected in to the line of a running infusion of the following fluids
Compatibility studies with other infusion fluids have not been performed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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