OxyContin 40mg tablets should be taken at 12-hourly intervals. The dosage is dependent on the severity of the pain, and the patient’s previous history of analgesic requirements.
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 4.4).
OxyContin 40mg is not intended for use as a prn analgesic.
Increasing severity of pain will require an increased dosage of OxyContin tablets, using the 5 mg, 10 mg, 20 mg, 40 mg or 80 mg tablet strengths, either alone or in combination, to achieve pain relief. The correct dosage for any individual patient is that which controls the pain and is well tolerated for a full 12 hours. Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this. If higher doses are necessary, increases should be made in 25% – 50% increments. The need for escape medication more than twice a day indicates that the dosage of OxyContin tablets should be increased.
The usual starting dose for opioid naïve patients or patients presenting with severe pain uncontrolled by weaker opioids is 10 mg, 12-hourly. Some patients may benefit from a starting dose of 5 mg to minimise the incidence of side effects. The dose should then be carefully titrated, as frequently as once a day if necessary, to achieve pain relief. For the majority of patients, the maximum dose is 200 mg 12-hourly. However, a few patients may require higher doses. Doses in excess of 1000 mg daily have been recorded.
Conversion from oral morphine:
Patients receiving oral morphine before OxyContin 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 OxyContin tablets required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.
A dose adjustment is not usually necessary in 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.
OxyContin should not be used in patients under 18 years of age.
Patients with renal or hepatic impairment:
The plasma concentration in this population may be increased. The dose initiation should follow a conservative approach in these patients. 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.
Use in 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. The need for continued treatment in non-malignant pain should be assessed at regular intervals.
Method of administration
OxyContin tablets are for oral use.
OxyContin tablets must be swallowed whole and not broken, chewed or crushed.
Duration of treatment
Oxycodone should not be used for longer than necessary.
Discontinuation of treatment
When a patient no longer requires therapy with OxyContin 40mg, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
Hypersensitivity to oxycodone or to any of the excipients listed in section , Oxycodone must not be used in any situation where opioids are contraindicated: severe respiratory depression with hypoxia, paralytic ileus, acute abdomen, delayed gastric emptying, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma, elevated carbon dioxide levels in the blood, moderate to severe hepatic impairment, chronic constipation.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Special warnings and precautions for use
The major risk of opioid excess is respiratory depression. Caution must be exercised when administering OxyContin 40mg to the debilitated elderly; patients with severely impaired pulmonary function, patients with impaired hepatic or renal function; patients with myxoedema, hypothyroidism, Addison’s disease, toxic psychosis, prostate hypertrophy, adrenocortical insufficiency, alcoholism, delirium tremens, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, hypotension, hypovolaemia, raised intracranial pressure, head injury (due to risk of increased intracranial pressure) or patients taking benzodiazepines, other CNS depressants (including alcohol) or MAO inhibitors.
Concomitant use of benzodiazepines and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs with opioids should be reserved for patients for whom alternative treatment options are not possible.
Prolonged release tablet.
The 5 mg tablets are light blue, round, convex tablets marked OC on one side and 5 on the other.
The 10 mg tablets are white, round, convex tablets marked OC on one side and 10 on the other.
The 15 mg tablets are grey, round, convex tablets marked OC on one side and 15 on the other.
The 20 mg tablets are pink, round, convex tablets marked OC on one side and 20 on the other.
The 30 mg tablets are brown, round, convex tablets marked OC on one side and 30 on the other.
The 40 mg tablets are yellow, round, convex tablets marked OC on one side and 40 on the other.
The 60 mg tablets are red, round, convex tablets marked OC on one side and 60 on the other.
The 80 mg tablets are green, round, convex tablets marked OC on one side and 80 on the other.
The 120 mg tablets are purple, round, convex tablets marked OC on one side and 120 on the other.