Oxycodone (Burns — Background Analgesia)

SCOPE: oral prolonged-release background analgesia from the UK SPC for Ixyldone 10 mg prolonged-release tablets. || ⚠ BURNS-RELEVANT WARNING, §4.4 verbatim: 'Do not use for acute post-operative pain owing to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI).' Read this against any plan to run prolonged-release oxycodone around burns surgery or grafting. || RESCUE / BREAKTHROUGH, verbatim: 'Some patients who take Ixyldone following a fixed schedule need rapid release analgesics as rescue medication in order to control breakthrough pain. Ixyldone is not indicated for the treatment of acute pain and/or breakthrough pain. The single dose of the rescue medication should amount to 1/6 of the equianalgesic daily dose of Ixyldone. Use of the rescue medication more than twice daily indicates that the dose of Ixyldone needs to be increased.' Note this is a rule for sizing a rescue dose from the background dose — it is not itself a milligram figure, and the SPC does not name the rescue product. || TITRATION, verbatim: 'The dose should not be adjusted more often than once every 1-2 days until a stable twice daily administration has been achieved. Following a dose increase from 10 mg to 20 mg taken every 12 hours dose adjustments should be made in steps of approximately one third of the daily dose. The aim is a patient-specific dosage which, with twice daily administration, allows for adequate analgesia with tolerable undesirable effects and as little rescue medication as possible as long as pain therapy is needed. In general, the lowest effective analgesic dose should be chosen.' || OPIOID CONVERSION, verbatim: 'According to well-controlled clinical studies 10-13 mg oxycodone hydrochloride correspond to approximately 20 mg morphine sulphate, both in the prolonged-release formulation. Because of individual differences in sensitivity for different opioids, it is recommended that patients should start conservatively with Ixyldone after conversion from other opioids, with 50-75% of the calculated oxycodone dose.' || RISK PATIENTS, verbatim: 'Risk patients, for example patients with low body weight or slow metabolism of medicinal products, should initially half the recommended adult dose if they are opioid naïve. Therefore, the lowest recommended dosage, i.e. 10 mg, may not be suitable as a starting dose.' (This strength cannot be halved — the tablets must not be divided — so a lower-strength product is needed: 'For doses not realisable/practicable with this strength other strengths of this medicinal product are available.') || ELDERLY, verbatim: 'Elderly patients without clinical manifestation of impaired liver and/or kidney function usually do not require dose adjustments.' || ALCOHOL: 'Ixyldone should not be taken with alcoholic beverages.' Food: 'The prolonged-release tablets may be taken with or independent of meals with a sufficient amount of liquid.' || STOPPING, verbatim: '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.' || US LABEL CROSS-CHECK (US labelling AND a different, immediate-release formulation — do not read it as this page's prolonged-release dose): 'Initiate treatment with oxycodone hydrochloride in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain and at the lowest dose necessary to achieve adequate analgesia.' US strengths: 'Immediate-release tablets: 5 mg, 10 mg, 15 mg, 20 mg, 30 mg'.

⚠ dosePerKg IS DELIBERATELY NULL: this SPC contains NO per-kilogram figure at any age. It doses by age band, not by weight — the posology is headed 'Adults and adolescents 12 years of age and older', so a 12- to 17-year-old is given the adult regimen: 'In general, the initial dose for opioid naïve patients is 10 mg oxycodone hydrochloride given at intervals of 12 hours. Some patients may benefit from a starting dose of 5 mg oxycodone hydrochloride to minimize the incidence of adverse reactions.' || UNDER 12 YEARS — NOT RECOMMENDED, verbatim: 'Children under 12 years of age Oxycodone has not been studied in children younger than 12 years of age. The safety and efficacy of Ixyldone have not been demonstrated and the use in children younger than 12 years of age is therefore not recommended.' || The SPC's low-body-weight caution applies to adolescents too: 'Risk patients, for example patients with low body weight or slow metabolism of medicinal products, should initially half the recommended adult dose if they are opioid naïve' — and because the tablets must not be divided, that requires a lower-strength product. || concentration is NULL: this is a prolonged-release TABLET, not a liquid; no mg/mL strength exists in this bundle. || No per-kg figure, and no regimen for children aged 1 to 11, appears in either label — the UK SPC positively does not recommend use below 12 years. Check paediatric opioid dosing against a children's formulary and a specialist paediatric pain service.