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. The use of Ultiva in mechanically ventilated intensive care patients is not recommended for a duration of treatment greater than 3 days.
Rapid offset of action/Transition to alternative analgesia: Due to the very rapid offset of action of Ultiva, no residual opioid activity will be present within 5-10 minutes after the discontinuation of Ultiva. For those patients undergoing surgical procedures where post-operative pain is anticipated, analgesics should be administered prior to discontinuation of Ultiva. The possibility of tolerance, hyperalgesia and associated haemodynamic changes should be considered when used in Intensive Care Unit. Prior to discontinuation of Ultiva, patients must be given alternative analgesic and sedative agents. Sufficient time must be allowed to reach the therapeutic effect of the longer acting analgesic. The choice of agent(s), the dose and the time of administration should be planned in advance and individually tailored to be appropriate for the patient's surgical procedure and the level of post-operative care anticipated. When other opioid agents are administered as part of the regimen for transition to alternative analgesia, the benefit of providing adequate post-operative analgesia must always be balanced against the potential risk of respiratory depression with these agents.
Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of Ultiva and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Ultiva concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see Interactions). 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).
Discontinuation of treatment and withdrawal syndrome: Repeated administration at short term intervals for prolonged periods may result in the development of withdrawal syndrome after cessation of therapy. Symptoms following withdrawal of Ultiva including tachycardia, hypertension and agitation have been reported infrequently upon abrupt cessation, particularly after prolonged administration of more than 3 days. Where reported, re-introduction and tapering of the infusion has been beneficial. The use of Ultiva in mechanically ventilated intensive care patients is not recommended for duration of treatment greater than 3 days.
Muscle rigidity - prevention and management: At the doses recommended muscle rigidity, sometimes severe, may occur. As with other opioids, the incidence of muscle rigidity is related to the dose and rate of administration. Therefore, slow bolus injections should be administered over not less than 30 seconds.
Muscle rigidity induced by Ultiva must be treated in the context of the patient's 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 - prevention and 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. Special care should be taken in patients with respiratory dysfunction. The appearance of respiratory depression should be managed appropriately, including decreasing the rate of infusion by 50% or by 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: The risk of cardiovascular effects such as hypotension and bradycardia, which may rarely lead to asystole/cardiac arrest (see Interactions and Adverse Reactions) may be reduced by lowering the rate of infusion of Ultiva or the dose of concurrent anaesthetics or by using IV fluids, vasopressor or anticholinergic agents as appropriate.
Debilitated, hypovolaemic, hypotensive and elderly patients may be more sensitive to the cardiovascular effects of Ultiva.
Inadvertent administration: A sufficient amount of Ultiva may be present in the dead space of the IV line and/or cannula to cause respiratory depression, apnoea and/or muscle rigidity if the line is flushed with IV fluids or other drugs. This may be avoided by administering Ultiva into a fast flowing IV line or via a dedicated IV line which is removed when Ultiva is discontinued.
Tolerance and opioid use disorder (abuse and dependence): Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids. Abuse or intentional misuse of opioids may result in overdose and/or death. The risk of developing OUD is increased in patients with a personal or a family history (parents or siblings) of substance use disorders (including alcohol use disorder), in current tobacco users or in patients with a personal history of other mental health disorders (e.g. major depression, anxiety and personality disorders).
Effects on ability to drive and use machines: After anaesthesia with Ultiva the patient should not drive or operate machinery. The physician should decide when these activities may be resumed. It is advisable that the patient is accompanied when returning home.
Use in Children: There is limited data available on use in neonates/infants under 1 year of age [see Neonates/infants (aged less than 1 year) under Dosage & Administration and Pharmacology: Pharmacodynamics under Actions].