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Plenadren is a brand name for Hydrocortisone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of adrenal insufficiency in adults.
Verbatim from this product's EMA label. Tap a section to expand.
Posology Plenadren is given as maintenance therapy. Oral replacement doses must be individualised according to the clinical response. A common maintenance dose is 20–30 mg per day, given once daily in the morning. In patients with some remaining endogenous cortisol production a lower dose may be sufficient.
40 mg is the highest maintenance dose studied. The lowest possible maintenance dosage should be used. 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, see also section ‘Use in intercurrent illness’ where other ways of temporarily increasing the dose of hydrocortisone is described.
Changing from conventional oral glucocorticoid treatment to Plenadren When changing patients from conventional oral hydrocortisone replacement therapy given three times daily to Plenadren, an identical total daily dose may be given.
2) 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.
3 Use in intercurrent illness 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, see section
Summary of the safety profile Hydrocortisone is given as replacement therapy aimed at restoring normal cortisol levels. The adverse reaction profile in the treatment of adrenal insufficiency is therefore not comparable to that in other conditions requiring much higher doses of oral or parenteral glucocorticoids.
Overall, the frequency and type of adverse reactions were similar for Plenadren once daily modified- release tablets and hydrocortisone tablets given three times daily in a 12-week study. There was an initial increase in the frequency of adverse reactions in about one in five patients, observed up to eight weeks after first changing from conventional hydrocortisone tablets given three times daily to once daily modified-release tablets.
2. Fatigue has been reported as very common. Tabulated list of adverse reactions A total of 80 patients (173 patient-years of data) have been treated with modified-release hydrocortisone in clinical studies. Adverse reactions from these studies and from postmarketing surveillance are listed below by system organ class and frequency as follows: Very common ( 1/10); common ( 1/100 to < 1/10).
MedDRA System Organ Class Frequency of adverse reactions Very common Common Nervous system disorders Vertigo Headache Gastrointestinal disorders Diarrhoea Upper abdominal pain Nausea Skin and subcutaneous tissue disorders Pruritus Rash Musculoskeletal and connective tissue disorders Arthralgia General disorders and administration site conditions Fatigue In addition the following adverse reactions have been reported for other hydrocortisone medicinal products given for indications other than adrenal insufficiency replacement therapy in higher doses (frequencies not known).
Immune system disorders Activation of infection (tuberculosis, fungal and viral infections including herpes). Endocrine disorders Induction of glucose intolerance or diabetes mellitus. 7 Metabolism and nutrition disorders Sodium and water retention and oedema tendency, hypertension, hypokalaemia.
4. 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.
2. Once the intercurrent illness episode is over, patients can return to the normal maintenance dose. 2. Renal impairment There is no need for dosage adjustment in patients with mild to moderate renal impairment. 2. Hepatic impairment There is no need for dose adjustment in mild to moderate hepatic impairment.
In case of severe hepatic impairment, the functional liver mass decreases and thus the metabolising capacity for hydrocortisone. 2. Paediatric population The safety and efficacy of Plenadren in children/adolescents aged below 18 years have not yet been established.
No data are available. 00 am in the morning. It should be swallowed whole; tablets should not be divided, chewed or crushed. If more than one daily administration is required the morning dose should be given as instructed, additional doses given later during the day can be given with or without food.
1. 4 Special warnings and precautions for use Acute adrenal insufficiency Acute adrenal insufficiency may develop in patients with known adrenal insufficiency who are on inadequate daily doses or in situations with increased cortisol need.
1. 4
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Psychiatric disorders Euphoria and psychosis, insomnia. Eye disorders Increased intraocular pressure and cataract. Gastrointestinal disorders Dyspepsia and deterioration of existing gastric ulcer. Skin and subcutaneous tissue disorders Cushing-like symptoms, stria, ecchymoses, acne and hirsutism, impaired wound healing.
Musculoskeletal and connective tissue disorders Osteoporosis with spontaneous fractures. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Events have been reported in patients treated with Plenadren. Adrenal crisis can develop in patients with acute adrenal insufficiency. Therefore, patients should be advised of the signs and symptoms of acute adrenal insufficiency and of adrenal crisis and the need to seek immediate medical attention.
9%) solution for infusion, should be administered according to current treatment guidelines. 2, ‘Use in intercurrent illness’. The patient must be carefully informed how to act in these situations and also advised to immediately seek medical attention should an acute deterioration occur; especially in cases of gastroenteritis, vomiting and/or diarrhoea leading to fluid and salt loss, as well as to inadequate absorption of oral hydrocortisone.
Patients with adrenal insufficiency and concomitant retroviral infection, such as HIV, need careful dose adjustment due to potential interaction with antiretroviral medicinal products and increased hydrocortisone dose due to the infection.
Scientific reports do not support immunosuppressive effects of hydrocortisone in doses that have been used for replacement therapy in patients with adrenal insufficiency. Therefore, there is no reason to believe that replacement doses of hydrocortisone will exacerbate any systemic infection or worsen the outcome of such an infection.
Moreover, there is no reason to believe that doses of hydrocortisone used for replacement therapy in adrenal insufficiency may reduce the response to vaccines and increase the risk of generalised infection with live vaccines. , chronic diarrhoea, due to the risk of impaired cortisol exposure.
There are no data in patients with confirmed slow gastric emptying or decreased motility disease/disorder. The clinical response should be monitored in patients with these conditions. Using higher than normal doses of hydrocortisone High (supra-physiological) dosages of hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.
Long-term treatment with higher than physiological hydrocortisone doses can lead to clinical features resembling Cushing´s syndrome with increased adiposity, abdominal obesity, hypertension and diabetes, and thus result in an increased risk of cardiovascular morbidity and mortality.
Old age and low body mass index are known risk factors for common adverse reactions of pharmacological doses of glucocorticoids such as osteoporosis, thinning of skin, diabetes mellitus, hypertension and increased susceptibility to infections.
All glucocorticoids increase calcium excretion and reduce the bone-remodelling rate. Patients with adrenal insufficiency on long-term glucocorticoid […]