HYDROCORTISONE

Posology Dosage must be individualised according to the response of the individual patient. The lowest possible dosage should be used. Long-term over replacement can lead to serious side effects including osteoporosis, diabetes, hypertension, susceptibility to infection and thinning of the skin.

The daily dose is typically split into a larger morning dose and a smaller afternoon and evening dose to approximate the natural diurnal rhythm. Regular patient review is required to titrate the dose against disease activity. 4). Replacement therapy In chronic adrenal insufficiency, a total daily dose of 15 to 25 mg in three divided doses is usually adequate.

5 mg in the evening is the recommended adult starting dose in the absence of other information. Daily doses in excess of 20 mg have been linked to increased long term mortality and should be avoided if possible, unless clinically indicated or else assessed with a hydrocortisone day curve as per local policies.

Monitor glucocorticoid replacement using clinical assessment (including body weight, postural blood pressure, signs of glucocorticoid excess) and stabilise patients on the lowest tolerated dose. Patients with aldosterone deficiency will require replacement with fludrocortisone (50-300 mcg) daily.

g. hydrocortisone sodium phosphate), which may be effective within minutes after parenteral administration, can be lifesaving. Paediatric population In chronic adrenocortical insufficiency, the dose should be approximately 8mg/ m2/day in three to four divided doses, adjusted to the needs of the individual child.

Elderly The dose should be reviewed regularly to avoid over-replacement and associated side effects since there is a reducing requirement with age. 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.

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 Oral

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) Infections and infestations: Infection*, candidiasis.

4).

Blood and lymphatic system disorders:

Leucocytosis.

Immune system disorders:

Hypersensitivity including anaphylaxis has been reported.

Endocrine disorders:

Suppression of the hypothalamo-pituitary-adrenal axis, cushingoid facies.

Metabolism and nutrition disorders:

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:

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 amnesia*.

* 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.

Eye disorders:

Increased intra-ocular pressure, glaucoma. 4).

Cardiac disorders:

Myocardial rupture following recent myocardial infarction, hypertrophic cardiomyopathy in prematurely born infants.

Vascular disorders:

Hypertension, thromboembolism.

Gastro-intestinal disorders:

Dyspepsia, peptic ulceration with perforation and haemorrhage, abdominal distension, oesophageal ulceration, acute pancreatitis, nausea.

Skin and subcutaneous tissue disorders:

Skin atrophy, striae, acne, telangiectasia, hirsutism.

Musculoskeletal and connective tissue disorders:

Proximal myopathy, osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture.

Reproductive system disorders:

Menstrual irregularity, amenorrhoea.

General disorders and administration site conditions:

Impaired healing, malaise.

Injury, poisoning and procedural complications:

Tendon rupture, bruising.

Investigations:

Weight increased. 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.

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.

4 Special warnings and precautions for use Patients should carry 'steroid treatment' cards, which give clear guidance on the precautions to be taken to minimise risk and which provide details of 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 reactions recover after either dose reduction or withdrawal, 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 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 gastrointestinal 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 or in those with a family history of diabetes mellitus, congestive heart failure, thrombophlebitis, exanthematous disease, chronic nephritis, acute glomerulonephritis, metastatic carcinoma, osteoporosis (postmenopausal patients are at special risk), 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 […]