⚠️ Warnings
Due to the effect of Arduan on respiratory muscles, the product may only be administered in the presence of a specialist in mechanical ventilation at a facility where mechanical ventilation equipment is available.
Anaphylactic and anaphylactoid reactions to neuromuscular blocking agents have been generally described in the literature. Although only a few such cases have been reported in connection with Arduan, the medicinal product should only be administered under conditions where such reactions can be treated immediately. Special caution is required when administering Arduan, particularly in cases of known previous anaphylactic reaction to a neuromuscular blocking agent, as allergic cross-reactivity between neuromuscular blocking agents is possible.
No increase in plasma histamine levels was observed following the administration of pipecuronium bromide at a dose of 0.10 mg/kg body weight.
Arduan has mild haemodynamic effects within the dose range used to produce muscle relaxation. Typical changes include a slight decrease in heart rate, systolic and diastolic blood pressure, and cardiac output. These changes are likely related to the effects of other medicinal products (fentanyl, thiopental, halothane) used concurrently during induction of anaesthesia. Probably due to these contributing factors, arrhythmias may occasionally occur. Pipecuronium bromide has no ganglion-blocking, vagolytic, or sympathomimetic effects. (See section 4.8)
In view of the above information, the administration and dosage of vagolytic agents in premedication should be carefully considered. (The vagostimulatory effects of concurrently used anaesthetics and the type of surgical procedure should also be taken into account.)
To avoid relative overdosage and to properly assess the recovery of neuromuscular transmission and muscle tone, the use of a peripheral nerve stimulator is recommended.
The following factors may affect the pharmacokinetics and/or muscle relaxation induced by Arduan:
Renal impairment
In renal failure, the neuromuscular blockade induced by Arduan and the subsequent recovery time for muscle tone may be prolonged.
Neuromuscular disorders
Caution is required when using Arduan in patients with neuromuscular disorders, as both enhancement and diminution of its effect may occur. In patients with myasthenia gravis and myasthenic syndrome (Lambert-Eaton syndrome), even a small dose of Arduan may produce a marked response. Therefore, even very small doses of Arduan are recommended in these patients only after careful consideration. Pre-operative optimisation of anticholinesterase therapy by a clinician experienced and qualified in this area is recommended in these patients. Non-depolarizing muscle relaxants must not be used for endotracheal intubation. Substantially lower doses are recommended, as these patients are in a state of "auto-neuromuscular blockade". Concurrent administration of anaesthetics and drugs affecting neuromuscular transmission (benzodiazepines) is not recommended. Anticholinesterase agents should be administered at the end of the surgical procedure, 10–15 minutes before the expected effect. Planned prolonged mechanical ventilation after the procedure should be anticipated. When switching to spontaneous ventilation, neuromuscular blockade and respiratory parameters should be monitored.
Hepatic impairment
Only limited information is available regarding patients with hepatic impairment. Arduan should only be used if the potential benefits outweigh the potential risks.
Malignant hyperthermia
Malignant hyperthermia has not been reported in connection with Arduan under either experimental or clinical conditions. Since muscle relaxants are never administered as monotherapy and malignant hyperthermia may occur during general anaesthesia even in the absence of known triggering agents, the clinician should be familiar with the early signs, diagnostic methods, and treatment of malignant hyperthermia.
Other
As with other neuromuscular blocking agents, acid-base balance and electrolyte homeostasis should be corrected before anaesthesia.
Hypothermia may prolong the effect of Arduan.
Hypokalaemia, digitalis therapy, diuretic treatment, hypermagnesaemia, hypocalcaemia (transfusions), dehydration, acidosis, hypoproteinaemia, hypercapnia, and cachexia may enhance and prolong the effect of Arduan.
As with other non-depolarizing muscle relaxants, Arduan may decrease partial thromboplastin time and prothrombin time.
Since magnesium salts potentiate neuromuscular blockade, recovery from neuromuscular blockade induced by muscle relaxants may be inadequate in women receiving magnesium sulphate for pregnancy-related toxaemia. In such cases, a peripheral nerve stimulator should be used.
Excipient
This medicinal product contains less than 1 mmol (23 mg) of sodium per ampoule of solvent, i.e. it is essentially "sodium-free".
