APO-TRAMADOL SR

What it is

APO-TRAMADOL SR contains tramadol hydrochloride and is available in modified release tablets containing 100 mg, 150 mg, or 200 mg of the active ingredient. Tramadol is a centrally acting synthetic analgesic with opioid-like effects. 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 in adults and adolescents over 12 years is 100 mg to 200 mg twice daily, preferably morning and evening, with a maximum daily dose not exceeding 400 mg per day. For initial titration therapy, a lower starting dose may be appropriate for some patients. 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 APO-TRAMADOL SR, and patients 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; dosages should be limited to the minimum required and patients monitored for respiratory depression and sedation, with caution advised against drinking alcohol. APO-TRAMADOL SR contains tramadol hydrochloride and is a potential drug of abuse, misuse and addiction, with addiction able to 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. Serotonin syndrome, a potentially life-threatening condition, has been reported in patients receiving tramadol in combination with other serotonergic agents or tramadol alone. Convulsions have been reported in patients receiving tramadol at the recommended dose levels, with the risk increased when doses exceed the recommended upper daily dose limit.

Contraindications

APO-TRAMADOL 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; postoperative management of children younger than 18 years 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

Information regarding PBS listing is not available in the provided source documents.

Regulatory history

APO-TRAMADOL SR was first listed on the ARTG on 10 March 2009 for all three strengths (100 mg, 150 mg, and 200 mg) in blister pack oral tablet form.