Hydrocortisone products: information for supporting intrathecal risk assessment

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

Hydrocortisone 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 hydrocortisone 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.

Amdipharm/ADVANZ (Efcortesol®)

Hydrocortisone sodium phosphate

Strength

100mg/mL in 1mL ampoules
100mg/mL in 5mL ampoules

Excipients

Disodium Edetate, disodium hydrogen phosphate (anhydrous), sodium acid phosphate, sodium formaldehyde bisulphite monohydrate, phosphoric acid (10% solution), water for injection

Osmolarity

No information

pH

7.5 – 8.5

Endotoxin content

≤ 70 IU/ml

Panpharma

Hydrocortisone sodium succinate

Strength

100mg vial

Excipients

Sodium hydrogen phosphate buffer

Osmolarity

260 – 292 mOsmol/kg

pH

7.0 – 8.0 (100mg in 2mL water for injection)

Endotoxin content

No information

Pfizer (Solu-Cortef®)

Hydrocortisone sodium succinate

Strength

100mg vial

Excipients

Sodium biphosphate, sodium phosphate

Osmolarity

260 – 292 mOsmol/kg

pH

7.0 – 8.0 (100mg in 2mL water for injection)

Endotoxin content

No information