Acecort: hydrocortisone immediate release tablets in low dosages

From 22 to 26 May 2021, Ace is present at the 23rd European Congress of Endocrinology. Meet us at our e-booth or contact us by using our contactform. For more information visit the website of the European Society of Endocrinology.

Ace Pharmaceuticals is a small and independent pharmaceutical firm in the Netherlands. We deliver custom pharmaceutical solutions for specific patient needs to ensure an expedient supply of medicines. Our state-of-the-art GMP facility is located in Zeewolde (center of the Netherlands). At our facility we develop, produce and pack a wide range of dosage forms like solids and aseptic/sterile products. Our product portfolio includes over 30 licensed medicines and more than 300 compounded products.

In 2020, Ace has obtained the Marketing Authorisation for Acecort®, hydrocortisone tablets, in the Netherlands. Currently a 1 mg, 5 mg and 10 mg tablet are licensed, including a combination pack of 5 mg and 10 mg tablets (NL-RVG 124716; 124718; 124719; 124838). Introductions of 2 mg and 3 mg tablets are foreseen for the end of 2021.

All tablets have a colour coating to mask the taste and make it easy to distinguish between strengths. 1 mg is white, 5 mg is orange and 10 mg is red. The 2 mg tablets are yellow and the 3 mg tablets pink.

The combination pack is a unique feature that contains 84 coated tablets in 4 blister strips of 21 tablets (a blister strip per week). The contents correspond with an often used dosing scheme of 10 mg in the morning and 5 mg in the afternoon and early evening (10-5-5).

Ace will make her hydrocortisone tablets available for all European prescribers by licensing the product in countries throughout Europe. First introductions are planned for Q4-2021 and include Germany, Denmark, Norway, Finland, Sweden and Belgium.

Acecort is indicated for the treatment of adrenal insufficiency in patients who cannot be prescribed hydrocortisone containing modified release medication, or who require extra adrenal cortex hormone due to stress or extra exertion. Detailed information on the rationale for the development of these tablets is included in our information for prescribers (PDF).

An English translation (draft) of the SmPC is available on our product pages. We can provide other translations upon request.

Besides hydrocortisone tablets, Ace also has fludrocortisone acetate 62.5 microgram tablets available under brand name Fludrace®. These tablets with breakline are currently solely licensed in the Netherlands (NL-RVG 50721). Fludrace is indicated to be used as supplement in primary adrenal insufficiency (Addison’s disease) and in congenital adrenal hyperplasia (adrenogenital syndrome) in addition to glucocorticoid therapy.