SUBLIMAZE

What it is

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

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. A reduced dose of 25 to 50 micrograms is recommended in elderly and poor risk patients for induction.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of SUBLIMAZE. Clinicians 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 SUBLIMAZE 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. Dosages and durations should be limited to the minimum required and patients monitored for signs and symptoms of respiratory depression and sedation. Patients should be cautioned not to drink alcohol while taking SUBLIMAZE. SUBLIMAZE poses risks of hazardous and harmful use which can lead to overdose and death. Patients' risk of hazardous and harmful use should be assessed before prescribing and monitored regularly during treatment. Because of the risks associated with opioids, SUBLIMAZE should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain. SUBLIMAZE may cause muscle rigidity, particularly involving the muscles of respiration. This effect is related to the dose and speed of injection and may be reduced by slow intravenous injection.

Contraindications

SUBLIMAZE is contraindicated in patients with known hypersensitivity or intolerance to fentanyl, any of the components of SUBLIMAZE or other opioid. It should not be administered to patients suffering from bronchial asthma. SUBLIMAZE 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. Use of SUBLIMAZE in patients who have received monoamine oxidase inhibitors within 14 days is not recommended. SUBLIMAZE may cause muscle rigidity upon intravenous administration, and the need for reversal with muscle relaxants contraindicates its use in patients with a history of myasthenia gravis. SUBLIMAZE is contraindicated in children two years of age or younger, as safe conditions for use have not been established. Use is contraindicated in patients after operative interventions in the biliary tract. Use in chronic long-term non-cancer pain is contraindicated.

Regulatory history

SUBLIMAZE fentanyl 100 micrograms/2 mL (as citrate) injection ampoule and SUBLIMAZE fentanyl 500 micrograms/10 mL (as citrate) injection ampoule were both first listed on the ARTG on 7 March 1994.