TRAMAL

What it is

Tramal is a medicine containing the active ingredient tramadol hydrochloride. It is available as modified release (sustained release) tablets in strengths of 100 mg, 150 mg, or 200 mg. Tramadol is a centrally acting synthetic analgesic with opioid-like effects that is not derived from natural sources and not chemically related to opiates. Its analgesic action involves binding to mu-opioid receptors and inhibition of reuptake of noradrenaline and serotonin.

Approved indications

— Management of severe pain where other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, the pain is opioid-responsive, and requires daily, continuous, long-term treatment.

Dosing overview

The recommended dose of Tramal in adults and adolescents over the age of 12 years is 100 mg to 200 mg twice daily, preferably morning and evening. The maximum daily dose should not exceed 400 mg per day. For initial titration therapy, a lower starting dose may be appropriate for some patients. The tablets are to be taken whole, not divided or chewed, with sufficient liquid, irrespective of food intake.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of Tramal. 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 tramadol 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 should be monitored for signs and symptoms of respiratory depression and sedation. Tramal contains tramadol hydrochloride, an opioid, and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed Tramal at recommended doses. The risk of addiction is increased in patients with a personal or family history of substance abuse or mental illness, and the risk increases the longer the drug is used and with higher doses. Tramadol can cause sleep-related breathing disorders including central sleep apnoea and sleep-related hypoxemia. Use of tramadol increases the risk of central sleep apnoea in a dose-dependent fashion. In patients who present with central sleep apnoea, the total opioid dosage should be decreased. Serotonin syndrome, a potentially life-threatening condition, has been reported in patients receiving tramadol in combination with other serotonergic agents. Symptoms may include mental status changes, autonomic instability and neuromuscular abnormalities. If serotonin syndrome is suspected, dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.

Contraindications

Tramal is contraindicated in individuals with known hypersensitivity to tramadol or any excipients; acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic drugs; severe respiratory disease, acute respiratory disease and respiratory depression; all children younger than 12 years of age; postoperative management of children younger than 18 years of age following tonsillectomy and/or adenoidectomy; patients receiving monoamine oxidase inhibitors or who have taken them within the last 14 days; known sensitivity to opioids; and patients with uncontrolled epilepsy or epilepsy not adequately controlled by treatment.

PBS listing

Tramal sustained release tablets are listed on the PBS in 100 mg, 150 mg, and 200 mg strengths with streamlined restrictions at ex-manufacturer prices of A$6.92, A$8.50, and A$9.32 respectively. Tramal sustained release 50 mg tablets are also listed with streamlined restriction at an ex-manufacturer price of A$3.43.

Regulatory history

Tramal sustained release tablets in 100 mg, 150 mg, and 200 mg strengths were first listed on the Australian Register of Therapeutic Goods on 21 September 2000.