Oxycodone hydrochloride

SCOPE: oral immediate-release adult analgesia from the UK SPC for the 5 mg/5 mL oral solution; no IV, SC or modified-release figure exists in this bundle. || STRENGTH OF THE PRODUCT THIS SPC COVERS: 5 mg per 5 mL (i.e. 1 mg/mL) — the 5 mg starting dose is 5 mL of this solution. || TITRATION, verbatim: 'The dosage is dependent on the severity of the pain, and the patient's previous history of analgesic requirements. Generally, the lowest effective dose for analgesia should be selected... The correct dosage for any individual patient is that which controls the pain and is well tolerated throughout the dosing period. Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this.' The dose 'should then be carefully titrated, as frequently as once a day if necessary, to achieve pain relief.' || CONVERSION FROM ORAL MORPHINE, verbatim: '10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. It must be emphasised that this is a guide to the dose of Oxycodone solution required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.' || ORAL TO PARENTERAL RATIO (a conversion ratio only — the SPC gives NO parenteral starting dose), verbatim: '2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It must be emphasised that this is a guide to the dose required.' || ELDERLY, verbatim: 'A dose adjustment is not usually necessary in elderly patients... compared with younger adults, the clearance of oxycodone is only slightly reduced. No untoward adverse drug reactions were seen based on age, therefore adult doses and dosage intervals are appropriate.' || BEFORE STARTING, verbatim: 'Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with oxycodone in order to minimise the risk of addiction and drug withdrawal syndrome.' Duration: 'Oxycodone should not be used for longer than necessary. In common with other strong opioids, the need for continued treatment should be assessed at regular intervals.' || NON-MALIGNANT PAIN, verbatim: 'Opioids are not first line therapy for chronic non-malignant pain, nor are they recommended as the only treatment. Types of chronic pain which have been shown to be alleviated by strong opioids include chronic osteoarthritic pain and intervertebral disc disease.' || PERI-PROCEDURAL, §4.4 verbatim: 'Oxycodone solution should be used with caution pre-operatively and within the first 12-24 hours post-operatively' and 'Patients about to undergo additional pain relieving procedures (e.g. surgery, plexus blockade) should not receive Oxycodone solution for 6 hours prior to the intervention.' || US LABEL CROSS-CHECK (US labelling for IMMEDIATE-RELEASE TABLETS — quoted as a cross-check, not substituted for the UK figure): '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'. The US label also directs: 'Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when initiating and renewing treatment', and 'Do not rapidly reduce or abruptly discontinue oxycodone hydrochloride in a physically dependent patient because rapid reduction or abrupt discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.' || NOT SUPPORTED BY THIS BUNDLE: the page's parenteral figures, its modified-release figures, the equianalgesic ratio '1.5:1' (the SPC's ratio is 10 mg oral oxycodone = 20 mg oral morphine, i.e. 2:1), the statement that brand-specific MR formulations are not interchangeable, and the routine laxative advice — none of these appears in the fetched sections. Controlled-drug scheduling is likewise not stated in either fetched label.

NO PAEDIATRIC DOSE EXISTS IN THIS BUNDLE, AND THE UK LABEL REFUSES THE AGE GROUP OUTRIGHT. §4.2, Paediatric population, verbatim: 'Oxycodone solution should not be used in patients under 18 years.' The adult posology is itself headed 'Adults over 18 years'. The US label in this bundle contains no paediatric section at all (no §8.4 was returned), so it neither supports nor bounds paediatric use either. dosePerKg and concentration are therefore both NULL and nothing is fed to the weight calculator.