OxyNorm® Sterile Solution for Injection or Infusion 10mg/ml

Therapeutic indications

For the treatment of moderate to severe pain in patients with cancer and post-operative pain.

For the treatment of severe pain requiring the use of a strong opioid.

Contraindications

OxyNorm ® injection is contraindicated in patients with known hypersensitivity to oxycodone or any of the other constituents, or in any situation where opioids are contraindicated; respiratory depression; head injury; paralytic ileus; acute abdomen; chronic obstructive airways disease; cor pulmonale; chronic bronchial asthma; hypercarbia; moderate to severe hepatic impairment; severe renal impairment (creatinine clearance <10 ml/min); chronic constipation; concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use; pregnancy.

Posology and method of administration

Route of administration:

Subcutaneous injection or infusion

Intravenous injection or infusion.

Posology:

The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication.

Adults over 18 years:

The following starting doses are recommended. A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases.

i.v. (Bolus): Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections. Administer a bolus dose of 1 to 10 mg slowly over 1-2 minutes. Doses should not be administered more frequently than every 4 hours.

i.v. (Infusion): Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections. A starting dose of 2 mg/hour is recommended.

i.v. (PCA): Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections. Bolus doses of 0.03 mg/kg should be administered with a minimum lock-out time of 5 minutes.

s.c. (Bolus): Use as 10 mg/ml concentration. A starting dose of 5 mg is recommended, repeated at 4-hourly intervals as required.

s.c. (Infusion): Dilute in 0.9% saline, 5% dextrose or water for injections if required. A starting dose of 7.5 mg/day is recommended in opioid naïve patients, titrating gradually according to symptom control. Cancer patients transferring from oral oxycodone may require much higher doses (see below).

Transferring patients between oral and parenteral oxycodone:

The dose should be based on the following ratio: 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. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.

Elderly:

Elderly patients should be treated with caution. The lowest dose should be administered with careful titration to pain control.

Patients with renal and hepatic impairment:

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.

Children under 18 years:

There are no data on the use of OxyNorm ® injection in patients under 18 years of age.

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.

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.