Revised SPC: Targinact (oxycodone/naloxone) prolonged-release tablets - all strengths
Section on treatment goals and discontinuation has been added to SPC. Central sleep apnoea syndrome (unknown frequency) and drug dependence (rare) have been added as adverse effects, as has toxic leukoencephalopathy after an oxycodone overdose.
Source:
electronic Medicines compendium
SPS commentary:
The SPC now advises that “before initiating treatment with Targinact, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines. During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered.”