SUBUTEX

What it is

SUBUTEX sublingual tablets contain buprenorphine (as hydrochloride) . SUBUTEX is available in three dosage strengths, 0.4 mg, 2 mg and 8 mg buprenorphine (as hydrochloride). SUBUTEX is an uncoated tablet intended for sublingual administration. Buprenorphine is a µ (mu) opioid receptor partial agonist, к (kappa) opioid receptor antagonist.

Approved indications

— Treatment of opioid dependence, within a framework of medical, social and psychological treatment.

Dosing overview

Treatment with SUBUTEX is intended for adults and children aged 16 years or over who have agreed to be treated for opioid dependence. The route of administration of SUBUTEX is sublingual. When treatment starts the dose of SUBUTEX should be taken at least 6 hours after the patient last used opioids and when the objective signs of withdrawal appear. The recommended starting dose is 4-8 mg SUBUTEX on day one, with a possible additional 4 mg depending on the individual patient's requirement. The suggested target total dose for Day One is in the range of 8-12 mg SUBUTEX. Before starting treatment with SUBUTEX, the maintenance dose of methadone should be reduced to the minimum daily dose that the patient can tolerate. The first dose of SUBUTEX should be taken at least 24 hours after the patient last used methadone. Most patients require daily buprenorphine doses in the range 12 – 24 mg to achieve stabilisation, although some patients require higher (e.g. up to 32 mg/day) or lower (4-8 mg/day) doses to achieve their treatment goals.

Key safety warnings

Although SUBUTEX is indicated for the treatment of opioid dependence it still poses risks of hazardous and harmful use which can lead to overdose and death. Serious, life-threatening or fatal respiratory depression may occur with the use of SUBUTEX. Be aware of situations which increase the risk of respiratory depression, 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. Patients and their caregivers should be made aware of the symptoms of respiratory depression. Patients and their caregivers should also be informed of the potential harms of consuming alcohol while taking SUBUTEX. SUBUTEX may cause severe, possibly fatal, respiratory depression in children who accidentally ingest it. Protect children against exposure.

Contraindications

Hypersensitivity to buprenorphine or any other component of the tablet. Children less than 16 years of age. Severe respiratory insufficiency. Acute intoxication with alcohol or other CNS depressant.

PBS listing

SUBUTEX 8 mg tablet (sublingual) is listed on the PBS as 1 item with streamlined restriction at an ex-manufacturer price of A$23.99. The 2 mg tablet (sublingual) is listed as 1 item with streamlined restriction at an ex-manufacturer price of A$8.48. The 400 microgram tablet (sublingual) is listed as 1 item with streamlined restriction at an ex-manufacturer price of A$4.98.

Regulatory history

SUBUTEX buprenorphine tablets in strengths of 0.4 mg, 2 mg, and 8 mg were first registered on the ARTG on 2 November 2000.