FENTANYL SANDOZ

What it is

FENTANYL is fentanyl citrate supplied as an injection solution, available in two strengths: 100 micrograms in 2 mL and 500 micrograms in 10 mL. It is presented as a clear, colourless particle-free solution for injection.

Approved indications

— Short duration analgesia during pre-medication, induction and maintenance of anaesthesia, and in the immediate post-operative period. — Opioid analgesic supplement to general and regional anaesthesia. — Combination with a neuroleptic as an anaesthetic pre-medication for the induction of anaesthesia, and as an adjunct in the maintenance of general and regional anaesthesia.

Dosing overview

Dosage should be individualised according to age, bodyweight, 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 may be administered intramuscularly 30 to 60 minutes prior to surgery. For induction as an adjunct to general anaesthesia, adults receive 50 to 100 micrograms intravenously initially, repeated at two to three minute intervals until desired effect is achieved; a reduced dose of 25 to 50 micrograms is recommended in elderly and poor risk patients. For maintenance, 25 to 50 micrograms intravenously or intramuscularly is given when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia. As an adjunct to regional anaesthesia, 50 to 100 micrograms may be administered intramuscularly or slowly intravenously when additional analgesia is required. In the post-operative period, 50 to 100 micrograms may be administered intramuscularly for the control of pain, tachypnoea and emergence delirium, with the dose repeated in one or two hours as needed. For induction and maintenance in children 2 to 12 years of age, a reduced dose of 20 to 30 micrograms per 10 kg is recommended.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of FENTANYL; 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. The risk is greatest during initiation of therapy or following an increase in dose, and patients should be monitored closely for respiratory depression at these times. Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Limit dosages and durations to the minimum required and monitor patients for signs and symptoms of respiratory depression and sedation; caution patients not to drink alcohol while taking FENTANYL. FENTANYL poses risks of hazardous and harmful use which can lead to overdose and death; assess the patient's risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment. FENTANYL may cause 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.

Contraindications

FENTANYL is contraindicated in patients with known hypersensitivity or intolerance to fentanyl, any of the components of FENTANYL or other opioid. FENTANYL should not be administered to patients suffering from bronchial asthma. FENTANYL should not be used in patients with severe respiratory disease, acute respiratory disease and those susceptible to respiratory depression, such as comatose patients who may have head injuries or brain tumour. The use of FENTANYL in patients who have received MAO inhibitors within 14 days is not recommended. FENTANYL is contraindicated in children two years of age or younger, as safe conditions for use have not been established. FENTANYL should not be used in patients after operative interventions in the biliary tract or in chronic (long term) non-cancer pain.

Regulatory history

FENTANYL was first registered on the ARTG on 10 November 2023, with four variants sponsored by Medsurge Pharma: FENTANYL MEDSURGE and FENTANYL MEDICIANZ, each available in 100 microgram/2 mL and 500 microgram/10 mL injection ampoules.