Ultiva Special Precautions

ULTIVA should be administered only in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons specifically trained in the use of anaesthetic drugs and the recognition and management of the expected adverse effects of potent opioids, including respiratory and cardiac resuscitation. Such training must include the establishment and maintenance of a patent airway and assisted ventilation.
As with all opioids, ULTIVA is not recommended for use as the sole agent in general anaesthesia.
Patients with a known hypersensitivity to opioids of a different class may exhibit a hypersensitivity reaction following administration of ULTIVA. Caution should be exercised before using remifentanil in these patients (see Contraindications).
Muscle rigidity - prevention and management: At the doses recommended muscle rigidity may occur. As with other opioids, the incidence of muscle rigidity is related to the dose and rate of administration. Therefore, bolus infusions should be administered over not less than 30 seconds.
Muscle rigidity induced by ULTIVA must be treated in the context of the patients clinical condition with appropriate supporting measures.
Excessive muscle rigidity occurring during the induction of anaesthesia should be treated by the administration of a neuromuscular blocking agent and/or additional hypnotic agents. Muscle rigidity seen during the use of ULTIVA as an analgesic may be treated by stopping or decreasing the rate of administration of ULTIVA. Resolution of muscle rigidity after discontinuing the infusion of ULTIVA occurs within minutes.
Alternatively an opioid antagonist may be administered, however this may reverse or attenuate the analgesic effect of ULTIVA.
Respiratory depression - management: As with all potent opioids, profound analgesia is accompanied by marked respiratory depression. Therefore, ULTIVA should only be used in areas where facilities for monitoring and dealing with respiratory depression are available. The appearance of respiratory depression should be managed appropriately including decreasing the rate of infusion by 50% or a temporary discontinuation of the infusion. Unlike other fentanyl analogues, ULTIVA has not been shown to cause recurrent respiratory depression even after prolonged administration. However, as many factors may affect post-operative recovery it is important to ensure that full consciousness and adequate spontaneous ventilation are achieved before the patient is discharged from the recovery area.
Cardiovascular effects: Hypotension and bradycardia (see Adverse Reactions) may be managed by reducing the rate of infusion of ULTIVA or the dose of concurrent anaesthetics or by using i.v. fluids, vasopressor or anticholinergic agents as appropriate.
Debilitated, hypovolaemic, and elderly patients may be more sensitive to the cardiovascular effects of ULTIVA.
Rapid offset of action: Due to the very rapid offset of action of ULTIVA, no residual opioid activity will be present within 5 to 10 minutes after the discontinuation of ULTIVA. For those patients undergoing surgical procedures where post-operative pain is anticipated, analgesics should be administered prior to or immediately following discontinuation of ULTIVA.
Sufficient time must be allowed to reach the maximum effect of the longer acting analgesic. The choice of analgesic should be appropriate for the patient's surgical procedure and the level of post-operative care.
Discontinuation of Treatment: Symptoms including tachycardia, hypertension and agitation have been reported infrequently upon abrupt cessation, particularly after prolonged administration of remifentanil. Where reported, re-introduction and tapering of the infusion has been beneficial.
Inadvertent administration: A sufficient amount of ULTIVA may be present in the dead space of the i.v. line and/or cannula to cause respiratory depression, apnoea and/or muscle rigidity if the line is flushed with i.v. fluids or other drugs. This may be avoided by administering ULTIVA into a fast-flowing i.v. line or via a dedicated i.v. line which is adequately cleared of residual drug or which is removed upon discontinuation of ULTIVA.
Drug abuse: As with other opioids ULTIVA may produce dependency.
Risks from Concomitant Use with Benzodiazepines: Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Ultiva with benzodiazepines. Observational studies have demonstrated that concomitant use of opioids and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
If the decision is made to newly prescribe a benzodiazepine and an opioid together, prescribe the lowest effective dosages and minimum durations of concomitant use.
If the decision is made to prescribe a benzodiazepine in a patient already receiving an opioid, prescribe a lower initial dose of the benzodiazepine than indicated in the absence of an opioid, and titrate based on clinical response.
If the decision is made to prescribe an opioid in a patient already taking a benzodiazepine, prescribe a lower initial dose of the opioid, and titrate based on clinical response.
Follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when Ultiva is used with benzodiazepines. Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk of overdose and death associated with the use of benzodiazepine (see Interactions).
Effects on Ability to Drive and Use Machines: If an early discharge is envisaged, following treatment using anaesthetic agents patients should be advised not to drive or operate machinery.