Magistral preparation of hydrocortisone tablets 5 mg

Updated 14 October 2016

We have previously announced that magistral preparation of hydrocortisone 5 mg does not require permission, because the marketed medicine hydrocortisone Takeda is only marketed as scored tablets (20 mg strength).

Hydrocortisone Orion 10 mg tablets are now marketed as scored tablets that can be divided into two equal doses. Consequently, doctors can prescribe one-half tablets of 5 mg. And pharmacies are no longer permitted to prepare magistral tablets containing hydrocortisone in the strength 5 mg, unless permission has been obtained from the Danish Medicines Agency.

Permission in special cases

If a doctor needs to prescribe magistral preparations of hydrocortisone in the strength 5 mg, the doctor must apply for permission from the Danish Medicines Agency so that the pharmacy can prepare hydrocortisone tablets 5 mg for the individual patient. The application must include a reason why one-half tablets of the marketed hydrocortisone Orion 10 mg cannot be used. The permission must be presented at the pharmacy every time the patient asks the pharmacy to accept the prescription for the magistral medicine.

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