Posology : מינונים

4.2    Posology and method of administration

OxyContin tablets must be swallowed whole, and not broken, chewed or crushed.
OxyContin tablets should be taken one tablet at a time. Take each tablet with enough water to ensure complete swallowing immediately after placing in the mouth. (see also section 4.4).

Adults over 18 years:
OxyContin 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 is not intended for use as a prn analgesic.

Generally, the lowest effective dose for analgesia should be selected.
Increasing severity of pain will require an increased dosage of OxyContin tablets, using the different 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.

Elderly patients:
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.

Pediatric population
OxyContin 10, 20, 40, 80: should not be used in patients under 18 years of age.
OxyContin 5: Safety and effectiveness of OxyContin in pediatric patients below the age of 18 years have not been established.

Adults with mild to moderate renal impairment and mild hepatic impairment: The plasma concentration in this population may be increased. Therefore dose initiation should follow a conservative approach. Patients should be started on OxyContin 5 mg 12-hourly or oxycodone HCl liquid 2.5 mg 6-hourly and titrated to pain relief as described above.


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.

Duration of treatment
Oxycodone should not be used for longer than necessary.

Discontinuation of treatment
When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.