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Shortage of DILAUDID hydromorphone hydrochloride 1mg/mL oral liquid

Alternative overseas product approved for supply to address DILAUDID shortage

18 May 2021

The Therapeutic Goods Administration (TGA) has authorised the supply of an alternative product to address a current shortage of DILAUDID hydromorphone hydrochloride 1mg/mL oral liquid.

Hydromorphone hydrochloride preparations are indicated for the 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.

DILAUDID hydromorphone hydrochloride 1mg/mL oral liquid (AUST R 67360) is the only registered hydromorphone hydrochloride oral liquid product marketed in Australia. The sponsor has advised the TGA that it is in shortage until 9 December 2021. Updated information provided by the company is available on the Medicine Shortage Reports Database.

Details of overseas alternative medicine

The alternative product, HYDROmorphone Hydrochloride 1mg/mL oral solution, USP 473 mL (Rhodes) (Rhodes HYDROmorphone), is usually only supplied overseas but has been approved for import and supply during the shortage.

IMPORTANT: ALLERGY WARNING

Rhodes HYDROmorphone CONTAINS SULFITES

  • Rhodes HYDROmorphone contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
  • Use of Rhodes HYDROmorphone is contraindicated in patients with hypersensitivity to sulfites.
  • Sulfites are not declared on the medicine label.

Information for health professionals

Medsurge Healthcare has distributed a Dear Health Care Professional Letter that provides further information. Health professionals should contact Medsurge Healthcare on 1300 788 261 for further information or to arrange supply.

Information about the approval of Rhodes HYDROmorphone has been published in the TGA's online Section 19A database.

Rhodes HYDROmorphone is contraindicated in patients with hypersensitivity to sulfites due to the presence of sodium metabisulfite. Sulfites are not declared on the medicine label.