OXYNORM Capsule, hard Ref.[27709] Active ingredients: Oxycodone

Route of administration

Oral.

In common with other strong opioids, the need for continued treatment should be assessed at regular intervals.

Posology

If an immediate release opioid formulation is used as rescue medication in addition to prolonged-release, the need for more than two “rescues” per day could be an indication that the prolonged-release dosage requires upward titration.

Elderly and adults over 18 years

OxyNorm capsules should be taken at 4-6 hourly intervals. The dosage is dependent on the severity of the pain and the sensitivity of the individual patient. The correct dosage per individual patient is the lowest dose which sufficiently controls the pain with no or tolerable side effects. The patient’s previous history of analgesic requirements, their body weight, and sex (higher plasma concentrations are produced in females), should also be taken into account when determining the dose.

Generally, the lowest effective dose for analgesia should be selected. Increasing severity of pain will require an increased dosage of OxyNorm capsules. If higher doses are necessary, increases should be made in 25% - 50% increments where possible. 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.

It is recommended that patients take the medication in a consistent manner in relation to the timing of meals (See section 5.2).

The correct dosage per individual patient is that which controls the pain with no or tolerable side effects.

Should be taken at 4-6 hourly intervals. The usual starting dose for opioid naive patients or patients presenting with severe pain uncontrolled by weaker opioids or debilitated elderly patients 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. The majority of patients will not require a daily dose greater than 400 mg. However, a few patients may require higher doses.

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 4.4).

Duration of treatment

Oxycodone should not be used longer than necessary. See section 4.4 Special warnings and precautions for use regarding the need for close monitoring for development of dependence and abuse.

Patients with renal or hepatic impairment

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.

Conversion from morphine

It must be emphasised that this is a guide to the dose of oxycodone required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose. Initially, a lower-than-equivalent dose may be advisable.

Oral

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 is a quide to the dose of OxyNorm capsules required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.

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.

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 dosed 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 starting dose for opioid naïve patients is 2.5 mg oxycodone 6-hourly, given as OxyNorm liquid.

Paediatric population

Opioids must only be used for appropriate indications and prescribed by a specialist experienced in managing severe pain in children, with careful assessments of the benefits and risks.

Adolescents (from 12 years to 18 years)

The usual starting dose for opioid-naïve patients presenting with severe pain uncontrolled by weak opioids is 5 mg OxyNorm capsules at 6-hour intervals.

The dose should then be carefully titrated, every day if necessary, to achieve sufficient pain relief. The dose can be reduced to 4-hour intervals if necessary but should not be taken more than 6 times a day.

Children below the age of 12 years

The safety and efficacy of oxycodone in children below 12 years of age has not yet been established. Currently available data are described in section 4.8, but no recommendation on posology can be made.

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 string opioids include chronic osteoarthritic pain and intervertebral disc disease.

Signs of oxycodone toxicity and overdosage are pin-point pupils, respiratory depression and hypotension. Circulatory failure and somnolence progressing to stupor or deepening coma, skeletal muscle flaccidity, bradycardia and death may occur in more severe cases. Toxic leukoencephalopathy has been observed with oxycodone overdose.

Treatment of oxycodone overdosage: primary attention should be given to the Establishment of patent airway and institution of assisted or controlled ventilation.

In case of massive overdosage, administer naloxone intravenously (0.4 to 2 mg for an adult and 0.01 mg/kg body weight for children) if the patient is in a coma or respiratory depression is present. Repeat the dose at 2 minute intervals if there is no response. If repeated doses are required then an infusion of 60% of the initial dose per hour is a useful starting point. A solution of 10 mg made up in 50 ml dextrose will produce 200 micrograms/ml for infusion using an IV pump (dose adjusted to the clinical response). Infusions are not a substitute for frequent review of the patient’s clinical state. Intramuscular naloxone is an alterative in the event that IV access is not possible. As the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-stablished. Naloxone is a competitive antagonist and large doses (4 mg) may be required in seriously poisoned patients.

For less severe overdosage, administer naloxone 0.2 mg intravenously followed by Increments of 0.1 mg every 2 minutes of required.

Naloxone should not be administered in absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdosage. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on oxycodone. In such cases, an abrupt of complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome.

Additional/ other considerations:

• Consider activated charcoal (50 g for adults, 10-15 g for children), if a substantial amount has been ingested within 1 hour, provided the airway can be protected.
• Gastric contents may need to be emptied as this can be useful in removing unabsorbed drug.

Four years.

Do not store above 30°C.

PVdC coated PVC blister packs with aluminium backing foil.

Polypropylene container with polyethylene lid.

Pack sizes: 56 capsules.

None stated.