Hydromorphone products: information for supporting intrathecal risk assessment

John Minshull, Deputy Director, London Medicines Information Service, Specialist Pharmacy ServicePublished

Hydromorphone products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration

Licensed for intrathecal use

Products licensed for intrathecal use are the first line option and should be used wherever suitable.

There are currently no known hydromorphone products licensed for intrathecal administration.

Not licensed for intrathecal use, limited information available

Products with partial information that are not licensed for intrathecal administration can still sometimes be used. Refer to the advice in our article and complete a risk assessment to enable you to interpret the details below and choose an appropriate product.

Napp (Palladone®)

Strength

2mg/mL in 1mL ampoule
10mg/mL in 1mL ampoule

Excipients

Citric acid anhydrous, sodium citrate, sodium chloride, sodium hydroxide solution 4% (for pH adjustment), hydrochloric acid 3.6% (for pH adjustment), water for injection

Osmolarity

approx. 287 mOsmol/kg (undiluted)

pH

3.5 – 4.5 (undiluted)

Endotoxin content

≤ 84 EU/mL

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Hydromorphone products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration
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