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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 for use during induction and/or maintenance of general anaesthesia under close supervision. Remifentanil is indicated for provision of analgesia in mechanically ventilated intensive care patients 18 years of age and over.
Verbatim from this product's MHRA label. Tap a section to expand.
Remifentanil should only be administered in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons specifically trained in the use of anaesthetics 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. 4). 1 General Anaesthesia The administration of remifentanil must be individualised based on the patient's response. 05 to 2 When given by bolus injection at induction remifentanil should be administered over not less than 30 seconds.
At the doses recommended above, remifentanil significantly reduces the amount of hypnotic medicinal products required to maintain anaesthesia. Therefore, isoflurane and propofol should be administered as recommended above to avoid an increase of haemodynamic effects of remifentanil (hypotension and bradycardia).
No data are available for dose recommendations for simultaneous use of other hypnotics other than those listed in the table with remifentanil. Induction of anaesthesia Remifentanil should be administered with a standard dose of hypnotic, such as propofol, thiopentone, or isoflurane, for the induction of anaesthesia.
Administering remifentanil after a hypnotic will reduce the incidence of muscle rigidity. 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.
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.
The most common undesirable effects associated with remifentanil are direct consequences of the effects of μ-opioid agonists. These undesirable effects resolve within minutes of discontinuing or decreasing the rate of remifentanil administration.
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 medicinal products and the recognition and management of the expected undesirable 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. Remifentanil should not be used as an analgesic in procedures where patients remain conscious or do not receive any airway support during the procedure.
Rapid offset of action/transition to alternative analgesia Due to the very rapid offset of action of remifentanil, patients may emerge rapidly from anaesthesia and 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. During administration of remifentanil as a μ-opioid agonist the potential for the development of tolerance, hyperalgesia and associated haemodynamic changes should be considered.
Therefore, prior to discontinuation of remifentanil, patients must be given alternative analgesic and sedative medicinal products at a sufficient time in advance to allow the therapeutic effects of these medicinal products to become established and to prevent hyperalgesia and concomitant haemodynamic changes.
3 Continuation of post-operative analgesia, prior to extubation Not recommended 1 0 to 1 Induction period of anaesthesia After administration of a hypnotic to achieve loss of consciousness, remifentanil should be administered at an initial infusion rate of 1 microgram/kg/min.
The use of bolus injections of remifentanil during induction in cardiac surgical patients is not recommended. Endotracheal intubation should not occur until at least 5 minutes after the start of the infusion. Maintenance period of anaesthesia After endotracheal intubation the infusion rate of remifentanil can be titrated upward in 25% to 100% increments, or downward in 25% to 50% decrements, every 2 to 5 minutes according to patient need.
Supplemental slow bolus doses, administered over not less than 30 seconds, may also be given every 2 to 5 minutes as required. 5 micrograms/kg. 2). Concomitant medicinal products At the doses recommended above, remifentanil significantly reduces the amount of hypnotic agent required to maintain anaesthesia.
Therefore, isoflurane and propofol should be administered as recommended above to avoid excessive depth of anaesthesia. No data are available for dose recommendations for simultaneous use of other hypnotics with remifentanil (see in section above: Administration by Manually Controlled Infusion (MCI), Concomitant medicinal products).
Guidelines for postoperative patient management Continuation of post-operative analgesia with remifentanil prior to extubation It is recommended that the infusion of remifentanil should be maintained at the final intra-operative rate during transfer of patients to the post-operative care area.
3). Establishment of alternative analgesia prior to discontinuation of remifentanil Due to the very rapid offset of action of remifentanil, no residual opioid activity will be present within 5 to 10 minutes after discontinuation. Prior to discontinuation of remifentanil, patients must be given alternative analgesic and sedative medicinal products at a sufficient time in advance to allow the therapeutic effects of these medicinal products to become established.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Therefore attention must be given to respiratory effects possibly combined with muscular rigidity. Special care is needed to adjust the dose to the patient requirements and ventilatory support may be required. Adequate facilities should be available for monitoring of patients administered remifentanil.
4). 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. 5). Doses of the following medicinal products used in anaesthesia have been reduced by up to 75 % when used concurrently with remifentanil: isoflurane, thiopentone, propofol, midazolam and temazepam.
Guidelines for discontinuation in the immediate postoperative 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 post- operative care. If the longer acting analgesic has not reached the appropriate effect before the end of surgery, the administration of remifentanil may need to be continued to maintain analgesia during immediate post-operative period until longer acting analgesic has reached the maximum effect.
It is recommended that patients should be closely monitored post-operatively for pain, hypotension and bradycardia. 3. 025 micrograms/kg/min to balance the extent of analgesia against the degree of respiratory depression. In […]
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 post-operative care. When other opioid medicinal products 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 medicinal products.
Risk from concomitant use of sedative medicinal products such as benzodiazepines or related medicinal products Concomitant use of Remifentanil and sedative medicinal products such as benzodiazepines or related medicinal products may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative medicinal products should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Remifentanil concomitantly with sedative medicinal products, 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). 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. g. major depression, anxiety and personality disorders). 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. Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with remifentanil.
To minimise symptoms of withdrawal tapering from a high dose may take weeks to months. Additional to the symptoms mentioned above the opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations.
Other symptoms may also develop including irritability, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, or increased respiratory rate. Muscle rigidity - prevention and management At the doses recommended muscle rigidity may occur.
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 […]
It is therefore recommended that the choice of medicinal product(s), the dose and the time of administration are planned before weaning the patient from the ventilator. 8). To minimise the risk of these occurring, adequate alternative analgesia must be established (as described above), before the remifentanil infusion is discontinued.
The infusion rate should be reduced by 25 % decrements in at least 10-minute intervals until the infusion is discontinued. During weaning from the ventilator the remifentanil infusion should not be increased and only down titration should occur, supplemented as required with alternative analgesics.
Haemodynamic changes such as hypertension and tachycardia should be treated with alternative medicinal products as appropriate. When other opioid agents are administered as part of the regimen for transition to alternative analgesia, the patient must be carefully monitored.
The benefit of providing adequate post-operative analgesia must always be balanced against the potential risk of respiratory depression with these agents. 2). In association with these agents, adequate analgesia for cardiac surgery is generally achieved at the higher end of the range of target blood remifentanil concentrations used for general surgical procedures.
Following titration of remifentanil to individual patient response, blood concentrations as high as 20 nanograms/ml have been used in clinical studies. At the doses recommended above, remifentanil significantly reduces the amount of hypnotic agent required to maintain anaesthesia.
Therefore, isoflurane and propofol should be administered as recommended above to avoid an increase of haemodynamic effects (hypotension and bradycardia) of remifentanil (see Table 4: Dosing Guidelines for Cardiac Anaesthesia above).
1). Guidelines for discontinuation / continuation in the immediate post-operative period At the end of surgery when the TCI infusion is stopped or the target concentration reduced, spontaneous respiration is likely to return at calculated remifentanil concentrations in the region of 1 to 2 nanograms/ml.
1). As there are insufficient data, the administration of remifentanil by TCI for the management of post-operative analgesia is not recommended. 1 Adults Remifentanil can be used for […]