Pure Oxycodone Powder

Oxycodone Hydrochloride 10 mg/ml Solution for Injection or Infusion.

Each ml contains oxycodone hydrochloride 10 mg (equivalent to 9 mg of oxycodone base).

Each 1 ml ampoule contains oxycodone hydrochloride 10 mg (equivalent to 9 mg of oxycodone base).

Each 2 ml contains oxycodone hydrochloride 20 mg (equivalent to 18mg of oxycodone base).

This medicinal product contains less than 1 mmol sodium (23 mg) per dose.

For full list of excipients, see Section 6.1.

Solution for injection or infusion (injection or infusion).

A Clear, colourless solution practically free of particles.

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.

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 one to two minutes.

Doses should not be administered more frequently than every four 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 five minutes.

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

Patients with mild to moderate renal impairment and/or mild hepatic impairment should be treated with caution. The lowest dose should be given with careful titration to pain control.

Children under 18 years:

There are no data on the use of Oxycodone 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.

Hypersensitivity to oxycodone or to any of the excipients listed in section 6.1,

Oxycodone must not be used in any situation where opioids are contraindicated: severe respiratory depression with hypoxia; paralytic ileus; acute abdomen; severe chronic obstructive lung disease; cor pulmonale; severe bronchial asthma; elevated carbon dioxide levels in the blood; moderate to severe hepatic impairment; chronic constipation.

The major risk of opioid excess is respiratory depression.

Caution must be exercised when administering oxycodone to the debilitated elderly; patients with severely impaired pulmonary function, patients with impaired hepatic or renal function; patients with myxedema, 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.