Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Contra Indications

As glycine is present in the formulation Ultiva is contra-indicated for epidural and intrathecal use.

Ultiva is contra-indicated in patients with known hypersensitivity to any component of the preparation and other fentanyl analogues.

Ultiva is contra-indicated for use as the sole agent for induction of anaesthesia.

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.

Rapid offset of action

Due to the very rapid offset of action of Ultiva, patients may emerge rapidly from anaesthesia and 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. 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. 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. Common post-operative events associated with the emergence from general anaesthesia, such as shivering, agitation, tachycardia, hypertension, may occur earlier following discontinuation 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.

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 injections should be administered over not less than 30 seconds.

Muscle rigidity induced by remifentanil must be treated in the context of the patient's clinical condition with appropriate supporting measures including ventilatory support. 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 remifentanil as an analgesic may be treated by stopping or decreasing the rate of administration of remifentanil. Resolution of muscle rigidity after discontinuing the infusion of remifentanil occurs within minutes. Alternatively an opioid antagonist may be administered, however this may reverse or attenuate the analgesic effect of remifentanil.

Respiratory depression - management

As with all potent opioids, profound analgesia is accompanied by marked respiratory depression. Therefore, remifentanil 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 by a temporary discontinuation of the infusion. Unlike other fentanyl analogues, remifentanil 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 may be managed by reducing 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, and elderly patients may be more sensitive to the cardiovascular effects of remifentanil.

Drug abuse

As with other opioids remifentanil may produce dependency.

Interactions

Remifentanil is not metabolised by plasmacholinesterase, therefore, interactions with drugs metabolised by this enzyme are not anticipated.

As with other opioids remifentanil, whether given by manually-controlled infusion or TCI, decreases the amounts or doses of inhaled and IV anaesthetics, and benzodiazepines required for anaesthesia. If doses of concomitantly administered CNS depressant drugs are not reduced patients may experience an increased incidence of adverse effects associated with these agents.

The cardiovascular effects of Ultiva (hypotension and bradycardia), may be exacerbated in patients receiving concomitant cardiac depressant drugs, such as beta-blockers and calcium channel blocking agents.

Adverse Reactions

The most common adverse events associated with remifentanil are direct extensions of μ-opioid agonist pharmacology. These are acute respiratory depression, bradycardia, hypotension and/or skeletal muscle rigidity. These adverse events resolve within minutes of discontinuing or decreasing the rate of remifentanil administration.

Post-operative shivering, apnoea, hypertension, hypoxia, pruritis, constipation, aches, sedation, nausea and vomiting have also been reported.

Very rarely, allergic reactions including anaphylaxis have been reported in patients receiving remifentanil in conjunction with one or more anaesthetic agents.

In common with other opioids, very rare cases of asystole, usually preceded by severe bradycardia, have been reported in patients receiving remifentanil in conjunction with other anaesthetic agents.

Manufacturer

Drug Availability

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