Hydrocortisone (Oral Replacement)

SCOPE — READ BEFORE PUBLISHING. Every figure above is for PLENADREN ONCE-DAILY MODIFIED-RELEASE TABLETS. It is NOT a dose for conventional immediate-release hydrocortisone tablets given in divided doses, and NOT a dose for Efmody dual-release capsules — neither product is in this bundle. There is NO congenital adrenal hyperplasia regimen anywhere in the fetched bundle. SWITCHING FROM CONVENTIONAL TABLETS (§4.2, verbatim): 'When changing patients from conventional oral hydrocortisone replacement therapy given three times daily to Plenadren, an identical total daily dose may be given. Due to a lower bioavailability of the daily dose of Plenadren compared to that of conventional hydrocortisone tablets given three times daily clinical response needs to be monitored and further dose individualisation may be required. Changing patients from hydrocortisone tablets given twice daily, cortisone acetate or synthetic glucocorticoids to Plenadren has not been studied, but changing to a hydrocortisone equivalent daily dose of Plenadren is recommended in these instances; further dose individualisation may be required.' INTERCURRENT ILLNESS (§4.2, verbatim): 'During intercurrent illness, there should be high awareness of the risk of developing acute adrenal insufficiency. In severe situations, an increase in dose is immediately required and oral administration of hydrocortisone must be replaced with parenteral, preferably intravenous treatment. Intravenous administration of hydrocortisone is warranted during transient illness episodes such as severe infections, in particular gastroenteritis associated with vomiting and/or diarrhoea, high fever of any aetiology or extensive physical stress, such as for instance serious accidents and surgery under general anaesthesia. In less severe situations when intravenous administration of hydrocortisone is not required, for instance low grade infections, fever of any aetiology and stressful situations such as minor surgical procedures, the normal oral daily replacement dose must be increased temporarily; the total daily dose should be increased by administering the maintenance dose twice or thrice daily with 8 +/- 2 hours intervals (an increase in number of administrations, not increasing the morning dose). This regimen has been documented in over 300 intercurrent illness episodes within the clinical study programme. At the discretion of the treating physician, immediate release hydrocortisone tablets can be given instead of Plenadren or may be added to treatment. Once the intercurrent illness episode is over, patients can return to the normal maintenance dose.' NOTE that the SPC's sick-day rule is an increase in the NUMBER OF ADMINISTRATIONS, not a doubling or trebling of the morning dose. ADDITIONAL DOSES UNDER STRESS (§4.2, verbatim): 'In situations when the body is exposed to excessive physical and/or mental stress, patients may need additional substitution of immediate release hydrocortisone tablets especially in the afternoon/evening.' ADRENAL CRISIS (§4.4, verbatim): 'During adrenal crisis parenteral, preferably intravenous administration of hydrocortisone in high doses, together with sodium chloride 9 mg/ml (0.9%) solution for infusion, should be administered according to current treatment guidelines' — no numeric crisis dose is given in this bundle. ELDERLY (§4.2, verbatim): 'In case of age-related low body weight, monitoring of the clinical response is recommended and dose adjustment to a lower dose may be required.' PAEDIATRIC (§4.2, verbatim, which is why paedDose is null): 'The safety and efficacy of Plenadren in children/adolescents aged below 18 years have not yet been established. No data are available.'