DILAUDID

What it is

DILAUDID is a tablet containing hydromorphone hydrochloride, available in strengths of 2 mg, 4 mg and 8 mg.

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

For non-opioid-tolerant adults, patients should be started at a conservative dose and titrated to an adequate level of analgesia. The recommended initial oral dose is 2 to 4 mg every four hours. Elderly patients may require lower doses. For patients currently receiving opioids, the starting dose of hydromorphone should be based on the prior daily opioid dose by converting the total daily dose of the previous opioid to an equivalent total daily dose of hydromorphone using an equianalgesic table, with a dose selected and adjusted to achieve at least 3–4 hours of pain relief. 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.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of DILAUDID, particularly during initiation or following a dose increase, and requires close monitoring. The risk is higher in elderly, frail or debilitated patients and those with renal and hepatic impairment or existing respiratory impairment such as chronic obstructive pulmonary disease or asthma. 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. The lowest dosages and shortest durations should be used, patients should be monitored closely, and patients should be cautioned not to drink alcohol while taking DILAUDID. DILAUDID should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate. DILAUDID poses risks of hazardous and harmful use which can lead to overdose and death, and patients' risk should be assessed before prescribing and monitored regularly during treatment. The risk of developing opioid use disorder is increased in patients with a personal or family history of substance abuse disorders, in current tobacco users, in patients with a personal history of other mental health disorders, and increases the longer the drug is used and with higher doses. Accidental ingestion or exposure of DILAUDID, especially by children, can result in a fatal overdose, and patients and their caregivers should be given information on safe storage and disposal. Opioids can cause sleep-related breathing disorders including central sleep apnoea and sleep-related hypoxaemia, with risk increasing in a dose-dependent manner, and may cause worsening of pre-existing sleep apnoea.

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

DILAUDID tablets are listed on the PBS in 2 mg, 4 mg and 8 mg strengths with streamlined and restricted access. The 2 mg tablet has an ex-manufacturer price of A$6.13, the 4 mg tablet A$8.24, and the 8 mg tablet A$16.06.

Regulatory history

DILAUDID tablets in 2 mg, 4 mg and 8 mg strengths were first registered on the ARTG on 20 August 1999. An injectable formulation containing 2 mg/1 mL was registered on 9 September 2016. In March 2018, the PBAC recommended a change for the listing of a 200 mL polyethylene terephthalate bottle replacement for severe disabling pain.