HYDROMORPHONE

What it is

Hydromorphone hydrochloride is a hydrogenated ketone of morphine and an opioid analgesic. Hydromorphone is thought to be approximately eight times as potent (by weight) as morphine. Hydromorphone is an opioid agonist with no antagonist activity.

Approved indications

— Short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated, or are otherwise inappropriate to provide sufficient management of pain.

Dosing overview

Safe and effective administration of Hydromorphone JUNO preparations depends upon a comprehensive assessment of the patient, with selection of starting dosage guided by the nature of the pain and concurrent medical status. All patients should be started at a conservative dose of hydromorphone and titrated to an adequate level of analgesia, balanced with an acceptable level of adverse effects. For non-opioid-tolerant patients, the recommended initial intramuscular or subcutaneous dose is 1 to 2 mg every four to six hours, and the intravenous dose is 0.5 to 1.0 mg given slowly over 2 to 3 minutes. Elderly patients may require lower doses of Hydromorphone JUNO preparations.

Key safety warnings

Hydromorphone should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain. Hydromorphone poses risks of hazardous and harmful use which can lead to overdose and death. Serious, life-threatening or fatal respiratory depression may occur with the use of hydromorphone, with risk greatest during initiation of therapy or following a dose increase. Patients should be monitored closely for respiratory depression at these times. The risk of life-threatening respiratory depression is higher in elderly, frail or debilitated patients and in those with existing renal or hepatic impairment, or impairment of respiratory function such as chronic obstructive pulmonary disease or asthma, and opioids should be used with caution and close monitoring in these patients. Concomitant use of hydromorphone with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma and death. Dosages and durations should be limited to the minimum required and patients monitored for signs and symptoms of respiratory depression and sedation. Patients should not drink alcohol while receiving hydromorphone. Accidental ingestion or exposure of hydromorphone, especially by children, can result in a fatal overdose. Patients and their caregivers should be given information on safe storage and disposal of unused hydromorphone.

Contraindications

Hydromorphone JUNO preparations are contraindicated in patients with known hypersensitivity to hydromorphone or to any of the ingredients; severe respiratory disease, acute respiratory disease, respiratory depression, status asthmaticus, paralytic ileus, concurrent monoamine oxidase inhibitors (MAOIs) or within 14 days of such therapy, pregnancy; premature infants and children, or during labour for delivery of premature infants.

PBS listing

An oral solution containing hydromorphone hydrochloride 1 mg per mL is listed on the PBS with 3 items. The restriction type is streamlined and the ex-manufacturer price is A$459.19.

Regulatory history

Hydromorphone JUNO (hydromorphone hydrochloride 2 mg/1 mL injection solution), Hydromorphone JUNO-HP (hydromorphone hydrochloride 10 mg/1 mL injection solution and 50 mg/5 mL injection solution), and Hydromorphone JUNO-XHP (hydromorphone hydrochloride 50 mg/1 mL concentrated injection) were first registered on the ARTG on 6 May 2019.