TRAMADOL-WGR SR

What it is

TRAMADOL-WGR SR is a modified release tablet containing tramadol hydrochloride as the active ingredient, available in strengths of 100 mg, 150 mg, or 200 mg. Tramadol is a centrally acting synthetic analgesic that is not derived from natural sources or chemically related to opiates, and exerts effects through binding to mu-opioid receptors and inhibition of reuptake of noradrenaline and serotonin.

Approved indications

TRAMADOL-WGR SR is indicated for the 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 the pain requires daily, continuous, long-term treatment. TRAMADOL-WGR SR is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. TRAMADOL-WGR SR is not indicated as an as-needed analgesia.

Dosing overview

The recommended dose of TRAMADOL-WGR SR in adults and adolescents over the age of 12 years is 100 mg to 200 mg twice daily, preferably morning and evening. For initial titration therapy, a lower starting dose may be appropriate for some patients. The maximum daily dose should not exceed 400 mg per day. 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 TRAMADOL-WGR SR, and patients at risk should be monitored 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 depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. TRAMADOL-WGR SR contains tramadol hydrochloride and is a potential drug of abuse, misuse and addiction, and addiction can occur in patients appropriately prescribed the medicine at recommended doses. The risk of addiction is increased in patients with a personal or family history of substance abuse or mental illness, and 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, with risk increasing in a dose-dependent fashion. Serotonin syndrome, a potentially life-threatening condition, has been reported in patients receiving tramadol in combination with other serotonergic agents or tramadol alone, and careful observation is advised if concomitant treatment is clinically warranted.

Contraindications

TRAMADOL-WGR SR is contraindicated in individuals with known hypersensitivity to tramadol or any excipients; acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic drugs; patients with 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; patients with known sensitivity to opioids; and patients with uncontrolled epilepsy or epilepsy not adequately controlled by treatment.

PBS listing

Information regarding PBS listing for TRAMADOL-WGR SR is not available in the provided documents.

Regulatory history

TRAMADOL-WGR SR tramadol hydrochloride sustained-release tablets in strengths of 100 mg, 150 mg and 200 mg were first listed on the Australian Register of Therapeutic Goods on 21 May 2024.