TRAMEDO SR

What it is

TRAMEDO 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 with opioid-like effects that is not derived from natural sources and works through 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. TRAMEDO SR is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. TRAMEDO SR is not indicated as an as-needed analgesia.

Dosing overview

The recommended dose of TRAMEDO SR 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. In patients with renal insufficiency the elimination of tramadol is delayed and prolongation of the dosage intervals should be carefully considered; in cases of severe renal insufficiency tramadol modified release tablets are not recommended. TRAMEDO SR should not be used in patients with severe hepatic insufficiency.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of TRAMEDO SR, particularly in situations that increase the risk of respiratory depression, and patients should be monitored closely, especially on initiation or following a dose increase. Concomitant use of TRAMEDO SR 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, and dosages and durations should be limited to the minimum required with monitoring for respiratory depression and sedation. TRAMEDO SR contains tramadol hydrochloride and is a potential drug of abuse, misuse and addiction, with addiction able to occur in patients appropriately prescribed TRAMEDO SR at recommended doses, and the risk increased in patients with a personal or family history of substance abuse or mental illness. TRAMEDO SR 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. Tramadol can cause sleep-related breathing disorders including central sleep apnoea, with use of the drug increasing the risk 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.

Contraindications

TRAMEDO 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; known sensitivity to opioids; and patients with uncontrolled epilepsy or epilepsy not adequately controlled by treatment. TRAMEDO SR must not be used for narcotic withdrawal treatment.

PBS listing

No source document provides information about PBS listing for TRAMEDO SR.

Regulatory history

TRAMEDO SR tramadol hydrochloride 100 mg, 150 mg and 200 mg modified release tablets in blister packs were first listed on the Australian Register of Therapeutic Goods on 10 March 2009.