OXYNORM 5MG CAPSULE [SIN13083P]

Product Info

OXYNORM 5MG CAPSULE

[SIN13083P]

Indication
The management of opioid responsive, moderate to severe pain.

Administration and dosage

OxyNorm® capsules should be swallowed whole and not opened, chewed or crushed.

Treatment goals and discontinuation:
Before initiating treatment with OxyNorm® capsules, 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 (see section Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

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)

* 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.

Contraindications
Hypersensitivity to opioids and to any of the constituents or in any situation where opioids are contraindicated, severe respiratory depression with hypoxia, cor pulmonale, cardiac arrhythmias, severe bronchial asthma, chronic bronchial asthma or other chronic obstructive airways disease, elevated carbon dioxide levels in the blood, paralytic ileus, acute abdomen, moderate to severe hepatic impairment, severe renal impairment (creatinine clearance < 10 mL/min), delayed gastric emptying, acute alcoholism, brain tumor, increased cerebrospinal or intracranial pressure, head injury, severe CNS depression, convulsive disorders, delirium tremens, hypercarbia, chronic constipation, concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use. Not recommended for pre-operative use.