TRAMADOL

What it is

Tramadol SR generichealth is a medicine containing tramadol hydrochloride as the active ingredient, available in modified release (sustained release) tablets in strengths of 100 mg, 150 mg, or 200 mg. Tramadol is a centrally acting synthetic analgesic that is not derived from natural sources nor chemically related to opiates, and acts through at least two complementary mechanisms: 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 dose of tramadol should be titrated according to the severity of the pain and the clinical response of the individual patient. The recommended dose 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. 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 SR generichealth, and situations which increase the risk of respiratory depression should be identified, dosing modified in at-risk patients, and patients 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 SR generichealth contains opioid tramadol hydrochloride and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed Tramadol SR generichealth at recommended doses, with increased risk in patients with a personal or family history of substance abuse or mental illness, and risk increasing with longer duration of use and higher doses. Drugs with mu-opioid receptor agonist activity, such as tramadol, can cause sleep-related breathing disorders including central sleep apnoea, with use increasing the risk in a dose-dependent fashion. Convulsions have been reported in patients receiving tramadol at the recommended dose levels, with risk increased when doses exceed the recommended upper daily dose limit.

Contraindications

Tramadol 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; known sensitivity to opioids; and patients with uncontrolled epilepsy or epilepsy not adequately controlled by treatment.

PBS listing

No information regarding PBS listing is provided in the source documents.

Regulatory history

Tramadol SR generichealth 100 mg, 150 mg, and 200 mg sustained-release tablets were first listed on the Australian Register of Therapeutic Goods on 9 November 2012.