PALEXIA

What it is

PALEXIA SR contains tapentadol (as hydrochloride) in strengths of 25, 50, 100, 150, 200 or 250 mg . The tablets are film-coated and oblong shaped, with distinct colours for each strength . Tapentadol is a centrally acting synthetic analgesic combining opioid and non-opioid activity in a single molecule, with binding affinity to the mu-opioid receptor and the ability to inhibit noradrenaline reuptake in the brain .

Approved indications

— 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

Dosing regimens should be individualised according to the severity of pain, previous treatment experience and the ability to monitor the patient, and PALEXIA SR should be taken twice daily, approximately every 12 hours . Patients not currently taking opioid analgesics should start treatment with single doses of 50 mg PALEXIA SR administered twice daily . A titration regimen in increments of 50 mg PALEXIA SR twice daily every 3 days was appropriate to achieve adequate pain control in most patients . Total daily doses greater than 500 mg tapentadol have not been studied and are therefore not recommended .

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of PALEXIA SR, with greatest risk during initiation of therapy or following a dose increase . Concomitant use of PALEXIA 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 . PALEXIA SR poses risks of hazardous and harmful use which can lead to overdose and death, and patients' risk should be assessed before prescribing and monitored regularly during treatment . Addiction can occur in patients appropriately prescribed PALEXIA SR at recommended doses, with increased risk in patients with a personal or family history of substance abuse or mental illness, and the risk increases with longer use and higher doses . Withdrawal symptoms could occur after abrupt discontinuation of treatment with tapentadol, and the dose may be advisable to taper gradually to prevent symptoms of withdrawal . Hyperalgesia may occur with the use of PALEXIA SR, particularly at high doses, and may manifest as an unexplained increase in pain or diffuse sensitivity not associated with the original pain .

Contraindications

PALEXIA SR is contraindicated in patients with a known hypersensitivity to tapentadol or any component of the product, in patients with severe respiratory disease, acute respiratory disease and respiratory depression, in any patient who has or is suspected of having paralytic ileus, in patients with acute intoxication with alcohol, hypnotics, centrally acting analgesics, or psychotropic drugs, and in patients who are receiving MAO inhibitors or who have taken them within the last 14 days .

PBS listing

PALEXIA SR is listed on the PBS in strengths of 50 mg, 100 mg, 150 mg, 200 mg and 250 mg as modified-release tablets with streamlined restriction, at ex-manufacturer prices of A$9.59, A$16.19, A$22.53, A$28.14 and A$32.89 respectively .

Regulatory history

PALEXIA IR (50 mg, 75 mg and 100 mg tablets) was first listed on the ARTG on 22 November 2010 . PALEXIA SR (50 mg, 100 mg, 150 mg, 200 mg and 250 mg tablets) was first listed on the ARTG on 19 January 2011 . The TGA approved PALEXIA SR for the management of moderate to severe chronic pain unresponsive to non-narcotic analgesia on 24 December 2010 . A 25 mg strength was added to the ARTG on 24 September 2015 .