TRAMEDO

What it is

TRAMEDO contains the active ingredient tramadol hydrochloride. Tramadol is a centrally acting synthetic analgesic of the aminocyclohexanol group with opioid-like effects. It is not derived from natural sources, nor is it chemically related to opiates. At least two complementary mechanisms appear applicable: 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, and the pain is opioid-responsive, and requires daily, continuous, long-term treatment.

Dosing overview

The recommended dose of TRAMEDO 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 TRAMEDO. 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 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. TRAMEDO contains the opioid, tramadol hydrochloride and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed TRAMEDO at recommended doses. The risk of addiction is increased in patients with a personal or family history of substance abuse (including alcohol and prescription and illicit drugs) or mental illness. The risk also increases the longer the drug is used and with higher doses. Drugs with mu-opioid receptor agonist activity, such as tramadol, can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Use of these drugs increases the risk of CSA in a dose-dependent fashion.

Contraindications

TRAMEDO 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 who are receiving monoamine oxidase (MAO) 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.

Regulatory history

TRAMEDO tramadol hydrochloride 50 mg capsule was first listed on the ARTG on 25 October 2005.