In use product safety assessment report for dexamethasone injection

· UKMi

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This report covers the two main issues with dexamethasone sodium phosphate injection –

1. Concerns continue to be raised about how the content and dose of dexamethasone are expressed in packaging and labelling as well as in standard resources such as the BNF. Incidents are still reported where confusion leads to dosage errors. Manufacturers use different approaches to describing dexamethasone content and dose.

2. Aspen has acquired the product license for the Organon preparation and re-formulated the injection to harmonise the formulations of dexamethasone solution for injection available from the company within the EU Market. This has resulted in changes to concentration (from 4mg/mL to 3.8mg/mL), storage conditions and presentation (see table below). With two other dexamethasone injections of lower concentration on the market and prescribers accustomed to prescribing 4mg (and multiples thereof) doses of dexamethasone, there may be a potential risk for administration of incorrect doses.


Acute CareDexamethasoneParenteral AdministrationPrimary CareSystem Safety