FENTANYL

4). Route of administration Intravenous administration either as a bolus or by infusion. Intramuscular administration. 4). To avoid bradycardia, it is recommended to administer a small intravenous dose of an anti-cholinergic just before anaesthetic induction.

6). Posology Fentanyl 50 micrograms/ml, by the intravenous route, can be administered to both adults and children. The dose of Fentanyl 50 micrograms/ml should be individualised according to age, body weight, physical status, underlying pathological condition, use of other drugs and type of surgery and anaesthesia.

Adults The usual dosage regimen in adults is as follows:

Table 1. Posology in adults Initial Supplemental Spontaneous Respiration 50 – 200 micrograms 50 micrograms Assisted Ventilation 300 – 3500 micrograms 100 – 200 micrograms Doses in excess of 200 micrograms are for use in anaesthesia only.

As a premedicant, 1-2 ml Fentanyl 50 micrograms/ml may be given intramuscularly 45 minutes before induction of anaesthesia. After intravenous administration in unpremedicated adult patients, 2 ml Fentanyl 50 micrograms/ml may be expected to provide sufficient analgesia for 10-20 minutes in surgical procedures involving low pain intensity.

10 ml Fentanyl 50 micrograms/ml injected as a bolus gives analgesia lasting about one hour. The analgesia produced is sufficient for surgery involving moderately painful procedures. Giving a dose of 50 micrograms/kg fentanyl will provide intense analgesia for some four to six hours, for intensely stimulating surgery.

Fentanyl 50 micrograms/ml may also be given as an infusion. 1 microgram/kg/minute. Alternatively the loading dose of fentanyl may be given as a bolus. Infusion rates should be titrated to individual patient response; lower infusion rates may be adequate.

Unless it is planned to ventilate post-operatively, the infusion should be terminated at about 40 minutes before the end of surgery. g. 08 micrograms/kg/minute are necessary if spontaneous ventilation is to be maintained. Higher infusion rates (up to 3 micrograms/kg/minute) have been used in cardiac surgery.

Fentanyl 50 micrograms/ml chemically incompatible with the induction agents thiopentone and methohexitone because of wide differences in pH. Paediatric population Children aged 12 to 17 years old Follow adult dosage. Children aged 2 to 11 years old The usual dosage regimen in children is as follows: Table 2.

The safety of fentanyl IV was evaluated in 376 subjects who participated in 20 clinical trials evaluating fentanyl IV as an anaesthetic. These subjects took at least 1 dose of fentanyl IV and provided safety data. 3). Including the above-mentioned adverse reactions, Table 1 displays adverse reactions that have been reported with the use of fentanyl IV from either clinical trials or postmarketing experience.

The displayed frequency categories use the following convention:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available clinical trial data). 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.

Warnings Tolerance and Opioid use disorder (abuse and dependence) Tolerance, physical dependence, and psychological dependence may develop upon repeated administration of opioids. Repeated use of opioids may lead to Opioid use disorder (OUD).

Abuse or intentional misuse of opioids may result in overdose and/or death. g. major depression, anxiety and personality disorders). For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses.

g. major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.

Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced. Patients may also supplement their treatment with additional pain relievers.

These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.

Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for analgesic treatment should be reviewed regularly. Drug withdrawal syndrome 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 fentanyl.

Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.

1 or to other opioids. - Respiratory depression, obstructive airways disease. Concurrent administration with monoamine oxidase inhibitors, or within 2 weeks of their discontinuation.