PALLADONE Prolonged release capsule Ref.[8904] Active ingredients: Hydromorphone

Posology

Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with hydromorphone in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).

Adults and children aged 12 years and above

Palladone SR capsules should be used at 12 hourly intervals. The dosage is dependent upon the severity of the pain and the patient’s previous history of analgesic requirements. 4 mg of hydromorphone has an efficacy approximately equivalent to 30 mg of morphine sulphate given orally. A patient presenting with severe pain should normally be started on a dosage of 4 mg Palladone SR capsules 12 hourly. Increasing severity of pain may require increased dosage of hydromorphone to achieve the desired relief.

Elderly and patients with renal impairment

The elderly and patients with renal impairment should be dose titrated with Palladone SR capsules in order to achieve adequate analgesia. It should be noted, however, that these patients may require a lower dosage to achieve adequate analgesia.

Patients with hepatic impairment

Contraindicated.

Paediatric population

Not recommended.

Method of administration

For oral use.

The capsules can be swallowed whole or opened and their contents sprinkled on to cold soft food.

Signs of hydromorphone toxicity and overdosage are pin-point pupils, respiratory depression and hypotension. Circulatory failure and somnolence progressing to stupor or deepening coma, pneumonia aspiration, skeletal muscle flaccidity, bradycardia and death may occur in more severe cases. Rhabdomyolysis progressing to renal failure has been reported in opioid overdosage.

Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur.

Treatment of overdosage

Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.

In the 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 alternative in the event 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-established. 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 if required.

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

Other supportive measures as indicated by the patient’s progress and clinical condition should be considered.

Additional/other considerations

Consider activated charcoal (50 g for adults, 1g/kg for children), if a substantial amount has been ingested within 1 hour, provided the airway can be protected. It may be reasonable to assume that late administration of activated charcoal may be beneficial for prolonged release preparations; however there is no evidence to support this.

Palladone SR capsules will continue to release and add to the hydromorphone load for up to 12 hours after administration and management of hydromorphone overdosage should be monitored accordingly. Gastric contents may need to be emptied as this can be useful in removing unabsorbed drug, particularly when a prolonged release formulation has been taken.

Eighteen months.

Do not store above 25°C. Store in the original package.

a) PVdC/PVC blister packs with aluminium backing foil.

b) Polypropylene containers with polyethylene lids.

Pack sizes: 30, 56, 60 capsules.

None stated.