HYDROCORTISONE

Posology Dosage must be individualised according to the response of the individual patient. The lowest possible dosage should be used. e. ). Undesirable effects may be minimised by using the lowest effective dose for the minimum period and by administering the daily requirement as a single morning dose or whenever possible, as a single morning dose on alternate days.

Frequent patient review is required to titrate the dose against disease activity. 4). Replacement therapy In chronic adrenocortical insufficiency, a dosage of 20 to 30mg a day is usually recommended, sometimes together with 4-6 g of sodium chloride or 50-300 micrograms of fludrocortisone daily.

g. dexamethasone sodium phosphate), which may be effective within minutes after parenteral administration, can be life- saving. 8mg/kg/day in two or three divided doses, adjusted to the needs of the individual child.

Elderly:

Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious consequences of the common side effects of corticosteroids in old age, especially osteoporosis, diabetes, hypertension, susceptibility to infection and thinning of the skin.

In patients requiring replacement therapy, the daily dose should be given when practicable, in two doses. The first dose in the morning should be larger than the second dose in the evening, thus simulating the normal diurnal rhythm of cortisol secretion.

Use in serious trauma or illness with known adrenal insufficiency or doubtful adrenocortical reserve Paediatric population: Doses are generally higher than that used for chronic adrenocortical insufficiency and should be selected as appropriate for the clinical situation.

g. surgery, infection, trauma). During stress it may be necessary to increase the dosage temporarily. Pre-operative use Anaesthetists must be informed if the patient is taking corticosteroids or has previously taken corticosteroids. 4).

Method of administration For oral administration.

4). The following side effects may be associated with the long-term systemic use of corticosteroids with the following frequency: Not known (cannot be estimated from available data) System organ class Frequency Undesirable effects Infections and infestations Not known Infectiona, candidiasis.

Blood and lymphatic system disorders Not known Leucocytosis. Immune system disorders Not known Hypersensitivity including anaphylaxis has been reported. Endocrine disorders Not known Suppression of the hypothalamo- pituitary-adrenal axis, cushingoid facies.

Metabolism and nutrition disorders Not known Sodium and water retention, hypokalaemia, hypokalaemic alkalosis, impaired carbohydrate tolerance with increased requirement for antidiabetic therapy, negative protein and calcium balance and increased appetite.

Psychiatric disorders Not known Euphoria, psychological dependence, depression, insomnia and aggravation of schizophrenia. Aggravation of epilepsy, depressed and labile mood and suicidal thoughts, mania, delusions, hallucinations, behavioural disturbances, irritability, anxiety, sleep disturbances, confusion and amnesiab.

4). Cardiac disorders Not known Myocardial rupture following recent myocardial infarction, hypertrophic cardiomyopathy in prematurely born infants. Vascular disorders Not known Hypertension, thromboembolism. Gastrointestinal disorders Not known Dyspepsia, peptic ulceration with perforation and haemorrhage, abdominal distension, oesophageal ulceration, acute pancreatitis, nausea.

Skin and subcutaneous tissue disorders Not known Skin atrophy, striae, acne, telangiectasia, hirsutism. Musculoskeletal and connective tissue disorder Not known Proximal myopathy, osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture.

Reproductive system disorders Not known Menstrual irregularity, amenorrhoea. General disorders and administration site conditions Not known Impaired healing, malaise. Injury, poisoning and procedural complications Not known Tendon rupture, bruising.

Investigations Not known Weight increased a. 4). b. Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids.

Paediatric population Growth suppression in infancy, childhood and adolescence, increased intracranial pressure with papilloedema in children (pseudotumour cerebri), usually after treatment withdrawal. 4). A withdrawal syndrome may also occur including fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and weight loss.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Patients should carry 'steroid treatment' cards, which give clear guidance on the precautions to be taken to minimise risk and which provide details of the prescriber, drug, dosage, and the duration of treatment. The lowest possible dosage of corticosteroids should be used and when reduction in dosage is possible, the reduction should be gradual.

8). Symptoms typically emerge within a few days or weeks of starting the treatment. 5), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most adverse reactions resolve after either dose reduction or withdrawal of the medicine, although specific treatment may be necessary.

Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.

Particular care is required when considering the use of systemic corticosteroids in patients with existing or a previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis.

Caution should be exercised in immunocompromised patients. Chickenpox is of particular concern since this normally minor illness may be fatal in immunosuppressed patients. Patients (or parents of children receiving hydrocortisone tablets) without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster.

If exposed, they should seek urgent medical attention. Passive immunisation with Varicella zoster immunoglobulin (VZIG) is needed by exposed non- immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months; this should be given within 10 days of exposure to chickenpox.

If a diagnosis of chickenpox is confirmed, the illness warrants specialist care and urgent treatment. Patients should be advised to take particular care to avoid exposure to measles and to seek immediate medical advice if exposure occurs.

Prophylaxis with intramuscular normal immunoglobulin may be needed. Live vaccines should not be given to individuals with impaired immune responsiveness caused by high doses of corticosteroids. Killed vaccines or toxoids may be given though their effects may be attenuated.

Corticosteroids should not be stopped and the dose may need to be increased. Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions due to amphotericin.

Moreover, there have been cases reported in which concomitant use of amphotericin and hydrocortisone was followed by cardiac enlargement and congestive failure. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.

Average and large dosages of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increase excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses.

Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. A report shows that the use of corticosteroids in cerebral malaria is associated with a prolonged coma and an increased incidence of pneumonia and gastro- intestinal bleeding.

If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation may occur. During prolonged corticosteroid therapy, these patients should receive prophylactic chemotherapy.

The use of hydrocortisone tablets in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis. Corticosteroids should be used with caution in renal insufficiency, hypertension, diabetes mellitus or in those with a family history of diabetes, congestive heart failure, thrombophlebitis, exanthematous disease, chronic nephritis, acute glomerulonephritis, metastatic carcinoma, osteoporosis (postmenopausal patients are at special risk), existing or previous history of severe affective disorders (particularly if there is a history of steroid-induced psychosis), epilepsy, previous steroid myopathy, liver failure, glaucoma (or family history of glaucoma), myasthenia gravis, non-specific ulcerative colitis if there is a probability of impending perforation, diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer.

Signs of peritoneal irritation following gastro-intestinal perforation in patients receiving large doses of corticosteroids may be minimal or absent. During treatment, the patient should be observed for psychotic reactions, weakness, electrocardiographic changes, hypertension and untoward hormonal effects.

Fat embolism has been reported as a possible complication of hypercortisonism. There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis. Prolonged courses of corticosteroids increase susceptibility to infections and their severity.

The clinical presentation of infections may also be atypical. Corticosteroids may mask some signs of infection and some serious infection such as septicaemia and tuberculosis may reach an advanced stage before being recognised. There […]

1. Contraindicated in infections including systemic infections where anti- infective therapy has not been started. High doses of corticosteroids impair the immune response to vaccines. Therefore the concomitant administration of live vaccines with corticosteroids should be avoided.