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REMIFENTANIL is a brand name for Remifentanil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Remifentanil is indicated as an analgesic agent for use during induction and/or maintenance of general anaesthesia. Remifentanil is indicated for provision of analgesia in mechanically ventilated intensive care patients of 18 years of age and over. This medicinal product is exclusive for hospital use.
Verbatim from this product's MHRA label. Tap a section to expand.
Remifentanil shall 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. Continuous infusions of remifentanil must be administered by a calibrated infusion device into a fast flowing IV line or via a dedicated IV line.
6 for additional information, including tables with examples of infusion rates by body weight to help titrate remifentanil to the patient’s anaesthetic needs). 4). 3). The content of one vial is for single use only. 6 for storage conditions of the reconstituted/diluted product and the recommended diluents).
For manually-controlled infusion remifentanil can be diluted to concentrations of 20 to 250 micrograms/ml (50 micrograms/ml is the recommended dilution for adults and 20 to 25 micrograms/ml for paediatric patients aged 1 year and over).
For TCI the recommended dilution of remifentanil is 20 to 50 micrograms/ml. General Anaesthesia The administration of remifentanil must be individualised based on the patient's response. Adults Administration by Manually-Controlled Infusion The following table summarises the starting injection/infusion rates and dose range.
05 to 2 When given by bolus injection remifentanil should be administered over not less than 30 seconds. At the doses recommended above, remifentanil significantly reduces the amount of hypnotic agent required to maintain anaesthesia.
2: Concomitant medication below).
Induction of anaesthesia:
Remifentanil should be administered with a standard dose of hypnotic agent, such as propofol, thiopental, or isoflurane, for the induction of anaesthesia. 5 to 1 micrograms/kg/min, with or without an initial bolus injection of 1 micrograms/kg given over not less than 30 seconds.
If endotracheal intubation is to occur more than 8 to 10 minutes after the start of the infusion of remifentanil, then a bolus injection is not necessary.
The most common undesirable effects associated with remifentanil are direct extensions of μ-opioid agonist pharmacology. These adverse events resolve within minutes of discontinuing or decreasing the rate of remifentanil administration.
Frequencies below are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 and <1/100), are rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Immune system disorders Rare:
Allergic reactions including anaphylaxis have been reported in patients receiving remifentanil in conjunction with one or more anaesthetic agents.
Psychiatric disorders Not known:
Drug dependence, withdrawal syndrome Nervous system disorders Very common: Skeletal muscle rigidity Rare: Sedation (during recovery from general anaesthesia) Not known: Convulsions Cardiac disorders Common: Bradycardia Rare: Asystole/cardiac arrest, usually preceded by bradycadia, has been reported in patients receiving remifentanil in conjunction with other anaesthetic agents.
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Remifentanil 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 remifentanil in mechanically ventilated intensive care patients is not recommended for a duration of treatment greater than 3 days.
Patients with a known hypersensitivity to opioids of a different class may exhibit a hypersensitivity reaction following administration of remifentanil. Caution should be exercised before using Remifentanil in these patients.
Rapid offset of action/ Transition to alternative analgesia:
Due to the very rapid offset of action of remifentanil, no residual opioid activity will be present within 5-10 minutes after the discontinuation of remifentanil. For those patients undergoing surgical procedures where post-operative pain is anticipated, analgesics should be administered prior to discontinuation of remifentanil.
The possibility of tolerance, hyperalgesia and associated haemodynamic changes should be considered when used in Intensive Care Unit. Prior to discontinuation of remifentanil, 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.
3). 1. Remifentanil is contra-indicated for use as the sole agent for induction of anaesthesia.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Maintenance of anaesthesia in ventilated patients:
After endotracheal intubation, the infusion rate of remifentanil should be decreased, according to anaesthetic technique, as indicated in the above table. Due to the fast onset and short duration of action of remifentanil, the rate of administration during anaesthesia can be titrated upward in 25% to 100% increments or downward in 25% to 50% decrements, every 2 to 5 minutes to attain the desired level of μ-opioid response.
In response to light anaesthesia, supplemental bolus injections may be administered every 2 to 5 minutes. g. laryngeal mask anaesthesia): In spontaneously breathing anaesthetised patients with a secured airway respiratory depression is likely to occur.
There is also a risk that muscle rigidity may occur. Special care is needed to adjust the dose to the patient requirements and ventilatory support and/or urgent intubation may be required. 04 micrograms/kg/min with titration to effect.
1 micrograms/kg/min has been studied. Bolus injections are not recommended in spontaneously breathing anaesthetised patients. Remifentanil should not be used as an analgesic in procedures where patients remain conscious or do not receive any airway support during the procedure.
5). Doses of the following agents used in anaesthesia: isoflurane, thiopentone, propofol and temazepam have been reduced by up to 75% when used concurrently with remifentanil. Guidelines for discontinuation/ continuation into the immediate post-operative period: Due to the very rapid offset of action of remifentanil no residual opioid activity will be present within 5 to 10 minutes after discontinuation.
For those patients undergoing surgical procedures where post-operative pain is anticipated, analgesics should be administered prior to discontinuation of remifentanil. 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 […]
Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Remifentanil 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 Remifentanil 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. 5).
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 remifentanil 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 remifentanil in mechanically ventilated intensive care patients is not recommended for duration of treatment greater than 3 days.
Inadvertent administration:
A sufficient amount of remifentanil 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 remifentanil into a fast flowing IV line or via a dedicated IV line which is removed when remifentanil 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, slow 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 ventilator 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 – prevention and 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 shall 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. 8) may be reduced by lowering the rate of […]