Dexamethasone 4 mg/ml injection (Organon Laboratories Limited): reformulation with changes in name, concentration, storage conditions, and presentation

From October 2014 Dexamethasone 4 mg/ml injection (Organon Laboratories Limited) will be replaced by Dexamethasone 3.8 mg/ml solution for injection (Aspen Pharma Trading Limited).

• From: Medicines and Healthcare products Regulatory Agency
• Published: 11 December 2014

• Therapeutic area: Cancer, Endocrinology, diabetology and metabolism, Immunology and vaccination, Infectious disease, Respiratory disease and allergy, Rheumatology

Article date: October 2014

Dexamethasone 4 mg/ml injection is indicated for general and local glucocorticoid injection therapy (eg, joint inflammation) and for any acute condition in which intravenous glucocorticoids may be life-saving (eg, severe asthma, severe allergic reactions, and cerebral oedema).

Dexamethasone 4 mg/ml injection has been reformulated to harmonise the formulations available within the EU market and to improve the manufacturing process. Aspen Pharma Trading Limited has taken over the licence from Organon Laboratories Ltd. All orders placed from October 2014 onwards will be supplied with the new formulation called Dexamethasone 3.8 mg/ml solution for injection (PL 39699/0060; Aspen Pharma Trading Limited). The old formulation, Dexamethasone 4 mg/ml injection (PL 00065/0106R; Organon Laboratories Limited), will no longer be available.

The reformulation will result in the following changes:

• Concentration: the concentration of the active substance in the reformulated product will be 3.8 mg/ml dexamethasone, which is equivalent to 5.0 mg/ml of dexamethasone sodium phosphate. The dose recommendations have not changed. However, due to the change in concentration, the dilutions will need to be amended. A dosing card has been developed to help administer the reformulated product (see further information below)
• Storage conditions: the reformulated product must be stored in the refrigerator at 2 to 8°C to reduce the potential for particle formation. The old formulation is associated with a very low risk of particle transfer to patients; no serious safety concerns are associated with the use of the old formulation
• Presentation: the reformulated product will be available in a glass vial containing 1 ml of solution for injection 
• Packaging: the carton of the reformulated product will be clearly marked “New formulation”, “Change in concentration”, and “Store in a refrigerator”

Advice for healthcare professionals:

• Take the new concentration of dexamethasone (3.8 mg/ml) into account when diluting the product for use (see dosing card in further information below)
• Store the reformulated product in a refrigerator at 2 to 8°C
• Use up your stocks of the old formulation before using the new formulation.
• Consult the new summary of product characteristics, technical information leaflet, and dosing card for further information

Further information

Dosing card (73Kb)

Summary of product characteristics (49Kb)

Patient information leaflet and technical information leaflet (85Kb)

Letter sent to healthcare professionals in September 2014 (123Kb)

Article citation: Drug Safety Update volume 8 issue 3, October 2014: A2

Published 11 December 2014