Pharmaniaga Fentanyl Special Precautions

Intravenous fentanyl should only be used by a trained anaesthetist in hospitals or other locations with facilities for intubation and assisted ventilation.
The vital functions of the patient have to be monitored routinely. This also applies to the postoperative period. Fentanyl has a strong dose dependent depressing effect on respiration which may be prolonged especially in the elderly. In neonates, respiratory depression is to be expected already after small doses. Generally, the risk of a delayed respiratory depression has to be considered. In cases of emergency appropriate instruments and medicinal products have to be available.
In isolated cases, in epileptic patients after a rapid and high dosage fentanyl application (19-36 microgram/kg) of 2 to 5 minutes duration, an electrical seizure activity was recorded electrocorticographically even in healthy brain regions. An impact on the intraoperative electrocorticographic focus localisation after lower fentanyl doses is not known until now.
Muscle rigidity may occur which may also lead to respiratory depression.
The incidence of this rigidity may be decreased by slow intravenous administration.
The reaction can be treated by controlled ventilation and when necessary by administration of a muscle relaxant.
Non-epileptic (myo)clonic reactions may occur.
After administration of fentanyl, an increase of the bile duct pressure and in isolated cases a spasm of the Sphincter of Oddi can be observed: This has to be taken into account during intraoperative diagnostic procedure in bile duct surgery and in pain management of intensive care patients.
As with all other opioids, fentanyl can have an inhibitory effect on intestinal motility. This should be considered in the pain management of intensive care patients with inflammatory or obstructive intestinal diseases.
Bradycardia and asystolia may occur when the patient has received an insufficient dose of an antimuscarinic agent or when fentanyl is combined with non-vagolytic muscle-relaxants. Bradycardia is treated with atropine.
Opioids may cause hypotension, especially in hypovolaemic patients and in patients with decompensated heart failure. Induction doses should be adapted and administered slowly, in order to prevent cardiovascular depression.
Appropriate measures should be taken to maintain a stable arterial pressure.
In neonates, there is a sufficient likelihood of developing a withdrawal syndrome after treatment of more than 5 days or a total dose of >1.6 mg/kg. The use of fast bolus injections of fentanyl should be avoided.
Patients with hepatic failure should be dosed carefully because of the probably disturbed metabolism.
Patients with renal insufficiency should be carefully checked on the symptoms of fentanyl toxicity. As a result of dialysis the volume of distribution of fentanyl may be altered, which can influence the serum concentrations.
When fentanyl is given together with droperidol, the user should be familiar with the specific properties and undesirable effects of both medications.
Effects on ability to drive and use machines: The use of fentanyl may cause a decreased level of reactiveness and concentration. Patients should be advised that the performance of skilled tasks such as driving or operating machinery might be impaired for a considerable time after administration of fentanyl. Patients should be accompanied on their way home after discharge and should be instructed to avoid alcohol.