DILAUDID-HP

What it is

DILAUDID-HP contains hydromorphone hydrochloride as its active ingredient. The brand is registered on the ARTG as injection ampoules in two strengths: 10 mg/1 mL and 50 mg/1 mL.

Approved indications

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

Dosing overview

When converting patients currently receiving opioids to DILAUDID, the hydromorphone dose should be selected and adjusted so that at least 3–4 hours of pain relief is achieved, based on the prior daily opioid dose and converted using an equianalgesic table. Only 1/2 to 2/3 of the estimated dose calculated from the equianalgesic table should be given for the first few doses, then increased as needed according to the patient's response. Periodic reassessment after initial dosing is always required.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of DILAUDID. Prescribers should be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase. Concomitant use of DILAUDID 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. DILAUDID contains the opioid hydromorphone and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed DILAUDID at recommended doses. Abuse or intentional misuse of DILAUDID may result in overdose and/or death. Opioids can cause sleep-related breathing disorders including central sleep apnoea. Opioid use increases the risk of central sleep apnoea in a dose-dependent manner. Accidental ingestion or exposure of DILAUDID, especially by children, can result in a fatal overdose of hydromorphone. Patients and their caregivers should be given information on safe storage and disposal of unused DILAUDID.

Contraindications

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

PBS listing

The 10 mg/1 mL injection is listed on the PBS with 2 items, streamlined restriction, and an ex-manufacturer price of A$7.52.

Regulatory history

DILAUDID-HP 10 mg/1 mL and 50 mg/1 mL injection ampoules were first listed on the ARTG on 9 September 2016.