OXYNORM 10MG CAPSULE

CAPSULE

**Administration and dosage** **_OxyNorm®_** capsules should be swallowed whole and not opened, chewed or crushed. _Non-malignant pain:_ 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. In common with other strong opioids, the need for continued treatment should be assessed at regular intervals. _Adults, elderly and children over 18 years:_ Prior to initiation and titration of doses, refer to the **Warnings and Precautions** section for information on special risk groups such as females and the elderly – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. **_OxyNorm®_** capsules should be taken at 4–6 hourly intervals. 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. Increasing severity of pain will require an increased dosage of **_OxyNorm®_** capsules. 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. **_OxyNorm®_** capsules will generally be used in a short term trial (4–6 weeks) to determine if the pain is opioid responsive, before transferring to a longer acting oxycodone preparation such as **_OxyContin®_** tablets, in accordance with the clinical guidelines on the use of opioid analgesics in such patients. The usual starting dose for opioid naive patients or patients presenting with severe pain uncontrolled by weaker opioids is 5 mg, 4–6 hourly. The dose should then be carefully titrated, as frequently as once a day if necessary, to achieve pain relief. 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 (see section Warnings and precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Conversion from oral morphine_ Patients receiving oral morphine before oxycodone therapy should have their daily dose based on the following ratio: 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 **_OxyNorm®_** capsules required. Inter-patient variability requires that each patient be carefully titrated to the appropriate dose. _Elderly patients_ Controlled pharmacokinetic studies in elderly patients (aged over 65 years) have shown that 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. _Adults with mild to moderate renal impairment and mild hepatic impairment_ The plasma concentration in this patient population may be increased. Therefore, dose initiation should follow a conservative approach. The recommended adult starting dose should be reduced by 50% (for example a total daily dose of 10 mg orally in opioid naïve patients), and each patient should be titrated to adequate pain control according to their clinical situation. The starting dose for opioid naïve patients is 2.5 mg oxycodone 6-hourly, given as **_OxyNorm®_** liquid. _Children under 18 years:_ OxyNorm® capsules should not be used in patients under 18 years. _Multiplication Factors for Converting the Daily Dose of Prior Opioids to the Daily Dose of Oral Oxycodone\*_ (Mg/Day Prior Opioid x Factor = Mg/Day Oral Oxycodone) **Oral Prior Parenteral** **Parenteral Opioid** Oxycodone 1 -- Codeine 0.15 -- Hydromorphone 4 20 Pethidine (Meperidine) 0.1 0.4 Methadone 1.5 3 Morphine 0.5 3 \\* to be used for conversion to oral oxycodone. For patients receiving high-dose parenteral opioids, a more conservative conversion is warranted. For example, for high-dose parenteral morphine, use 1.5 instead of 3 as a multiplication factor. _Cessation of Therapy:_ When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.