The TGA has authorised the supply of two alternative products to address the discontinuation of Dilaudid hydromorphone hydrochloride 1mg/mL oral liquid
The TGA notes that this preparation (AUST R 67360) is the only registered hydromorphone hydrochloride oral liquid product marketed in Australia.
“The sponsor has advised the TGA this medicine has been discontinued as of 31 August 2021,” says the TGA.
Two other hydromorphone preparations, normally only supplied overseas, have now been approved for import and supply during the shortage, it advises.
These are HYDROmorphone Hydrochloride 1mg/mL oral solution, USP 473 mL (Rhodes), and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION 1mg/mL USP 473mL (West-Ward).
It issued an important allergy warning, advising that while sulfites are not declared on the medicines labels, these will be an issue for some patients.
Rhodes HYDROmorphone and West-Ward Hydromorphone contain 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 and West-Ward Hydromorphone is contraindicated in patients with hypersensitivity to sulfites.