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The alert from the Spanish Medicines Agency about a powerful anti-inflammatory

The Spanish Agency for Medicines and Health Products (Aemps) has launched an alert about a powerful anti-inflammatory to “avoid risks of medication errors.” This is Actocortin 100 mg Powder and Solvent for Injectable Solution, which has been renamed Actocortin 75 mg Powder and Solvent for Injectable Solution. According to Aemps, this change in nomenclature has been made to comply with European guidelines that dictate that the name of this type of drug must express the dose as a base instead of as a salt.

The possible danger may come because “a higher dose is administered mistakenly thinking that the new Actocortin has a quarter less concentration,” says the Agency. The agency explains that despite this name change, “both presentations contain the same dose of active ingredient (100 mg of hydrocortisone sodium phosphate equivalent to 74.53 mg of hydrocortisone).”

With this alert, we try to avoid possible confusion, since both presentations of this drug will coexist in the pharmaceutical channel until the last released lots of Actocortin 100 mg Powder and Solvent for Injectable Solution expire.

Furthermore, the Aemps points out that there are two formulations with the same active ingredient and pharmaceutical form that, as recommended by the European guidelines, do express the dose in the form of a base active ingredient:

– Hydrocortisone Pharmis 100 mg Powder and Solvent for Injection Solution and Infusion EFG

– Hydrocortisone Lorien 100 mg Powder for Solution for Injection and Infusion EFG

In both medications, each vial contains 133.7 mg of hydrocortisone sodium succinate equivalent to 100 mg of hydrocortisone. These are, therefore, medications that contain different amounts of hydrocortisone base and their dosage must be adjusted to the different amount of active ingredient in each formulation, as specified in the technical information sheet and leaflet for both.

For what do you use it

Actocortin 75 mg Powder and Solvent for Injectable Solution belongs to a group of hormonal preparations called systemic corticosteroids that act as powerful anti-inflammatories.

As indicated in its package insert, it is used for the treatment of acute exacerbations of asthma, anaphylactic shock and acute immediate hypersensitivity reactions that constitute a danger to the patient’s life (such as angioedema or laryngeal edema), acute adrenal insufficiency, treatment of acute rejection of organ transplantation, hypothyroid coma, necrotizing vasculitis, rheumatoid arthritis, tenosynovitis and bursitis.

This drug is on the list of 646 products with supply problems in pharmacies published by the Aemps.