FENTANYL-HAMELN

What it is

Fentanyl-hameln solution for injection is a clear colourless solution with a pH 3.8–7.5. The product is available in two strengths: 100 micrograms per 2 mL and 500 micrograms per 10 mL, each containing fentanyl as citrate. Fentanyl is a potent opioid analgesic with a rapid onset and short duration of action.

Approved indications Fentanyl-hameln is indicated for:

— Analgesic action of short duration during anaesthetic periods, premedication, induction and maintenance, and in the immediate post-operative period (recovery room) as the need arises — Use as an opioid analgesic supplement in general and regional anaesthesia — Administration with a neuroleptic such as droperidol injection as an anaesthetic premedication, for the induction of anaesthesia, and as an adjunct in the maintenance of general and regional anaesthesia

Dosing overview

Dosage should be individualised, with factors to be considered including age, body weight, physical status, underlying pathological condition, use of other drugs, type of anaesthesia to be used, and the surgical procedure involved. For premedication in adults, 50 to 100 micrograms (1 to 2 mL) may be administered intramuscularly 30 to 60 minutes prior to surgery. For induction as an adjunct to general anaesthesia, 50 to 100 micrograms (1 to 2 mL) may be administered initially intravenously and may be repeated at 2 to 3 minute intervals until the desired effect is achieved, with a reduced dose as low as 25 to 50 micrograms (0.5 to 1 mL) recommended in elderly and poor-risk patients. For maintenance, 25 to 50 micrograms (0.5 to 1 mL) may be administered intravenously or intramuscularly when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia. For adjunct to regional anaesthesia, 50 to 100 micrograms (1 to 2 mL) may be administered intramuscularly or slowly intravenously when additional analgesia is required. Post-operatively in the recovery room, 50 to 100 micrograms (1 to 2 mL) may be administered intramuscularly for the control of pain, tachypnoea, and emergence delirium, with the dose repeatable in one or two hours as needed.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of Fentanyl-hameln, and prescribers should be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase. Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Fentanyl-hameln poses risks of hazardous and harmful use which can lead to overdose and death, and the patient's risk of hazardous and harmful use should be assessed before prescribing and monitored regularly during treatment. Addiction can occur in patients appropriately prescribed Fentanyl-hameln at recommended doses, and the risk of addiction is increased in patients with a personal or family history of substance abuse (including alcohol and prescription and illicit drugs) or mental illness, with the risk also increasing the longer the drug is used and with higher doses. Fentanyl-hameln may cause muscle rigidity, particularly involving the muscles of respiration, and this effect is related to the speed of injection and its incidence can be reduced by a slow intravenous injection, premedication with benzodiazepines and the use of muscle relaxants.

Contraindications

Fentanyl-hameln is contraindicated in patients with known intolerance to fentanyl, any of the components of Fentanyl-hameln or other opioids. Fentanyl-hameln should not be administered to children two years of age or younger, because safe conditions for use have not been established. Fentanyl-hameln should not be administered to patients suffering from bronchial asthma. As for any opioid analgesic, it should not be used in patients with severe respiratory disease, acute respiratory disease and who may be particularly susceptible to respiratory depression, such as comatose patients who may have a head injury or brain tumour. The use of Fentanyl-hameln in patients who have received MAO inhibitors within 14 days is not recommended. Fentanyl-hameln may cause thoracic muscle rigidity upon intravenous administration, and therefore, the need for reversal with muscle relaxants contraindicates its use in patients with a history of myasthenia gravis. Fentanyl-hameln is contraindicated for use in chronic (long-term) non-cancer pain (CNCP).

Regulatory history

Fentanyl-hameln was first listed on the Australian Register of Therapeutic Goods on 22 April 2025, with both the 100 microgram/2 mL and 500 microgram/10 mL strengths registered under licence category RE.