HISONE

Posology Dosage must be individualised according to the response of the individual patient. The lowest possible dosage should be used. g. surgery, infection, trauma). During stress it may be necessary to increase the dosage temporarily.

4). 4). 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.

Acute emergencies 60–80 mg every 4–6 hours for 24 hours, then gradually reduce the dose over several days. 4). 4). 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 alternative days.

Frequent patient review is required to titrate the dose against disease activity. Method of administration Hisone 5 mg, 10 mg and 20 mg Dispersible Tablets are best taken dispersed in approximately 50ml of water. The suspension should be swallowed immediately, following which a further 200 ml of water, approximately, should be used to rinse around the glass 2 -3 times, and swallowed.

This is to ensure no residual drug particles are left behind in the glass and that the entire dose is consumed. Hisone dispersible tablets may also be swallowed whole if desired.

4). Adverse events are which have been associated with Hydrocortisone are given below, listed by system organ class and frequency. Undesirable effects are especially likely to occur at treatment onset or at dose increase. The undesirable effects are listed below by organ class and the following frequency convention: Very common: ≥1/10 Common: ≥1/100, <1/10 Uncommon: ≥1/1,000, <1/100 Rare: ≥1/10,000, <1/1,000 Very rare: <1/10,000 Not known: cannot be estimated from available data System organ class Frequency Undesirable effects Infections and infestations Not known Infectiona Blood and lymphatic system disorders Not known Leucocytosis.

Immune system disorders Not known Hypersensitivity including anaphylaxis has been reported. Endocrine disorders Not known Increased or decreased motility and number of spermatozoa, menstrual irregularities, amenorrhoea, development of Cushingoid state, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, hyperglycemia, increased requirements for insulin or oral hypoglycaemic agents in diabetes, hirsutism.

Metabolism and nutrition disorders Not known Sodium retention, fluid retention, hypokalaemia, hypokalaemic alkalosis, increased calcium excretion, negative nitrogen balance due to protein catabolism, weight gain, increased appetite.

Psychiatric disorders Not known Psychic disturbances, psychological dependence, depression, insomnia. A wide range of psychiatric reactions including affective disorders ( such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations and aggravation of schizophrenia), aggravation of epilepsy, behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesiab have been reported.

Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions have been estimated to be 5-6%. Nervous system disorders Not known Convulsions, increased intracranial pressure with papilloedema (pseudotumour cerebri) usually after treatment, vertigo, headache, malaise.

4). 4), congestive heart failure in susceptible patients. Vascular disorders Not known Thrombo-embolism, hypertension. Respiratory, thoracic and mediastinal disorders Not known Hiccups. Gastrointestinal disorders Not known Peptic ulcer with possible perforation and haemorrhage, perforation of the small and large bowel particularly in patients with inflammatory bowel disease, pancreatitis, abdominal distension, ulcerative oesophagitis, dyspepsia, oesophageal candidiasis, nausea.

Skin and subcutaneous tissue disorders Not known Impaired wound healing, thin fragile skin, petechiae, and ecchymoses, erythema, striae, telangiectasia, acne, increased sweating, may suppress reactions to skin tests, other cutaneous reactions such as allergic dermatitis, urticaria, angioneurotic oedema.

Musculoskeletal and connective tissue disorder Not known Muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis (especially in post- menopausal females), vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathological fracture of long bones, avascular osteonecrosis, tendon rupture.

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 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.

Thyrotoxic Periodic Paralysis (TPP) can occur in patients with hyperthyroidism and with hydrocortisone-induced hypokalaemia. TPP must be suspected in patients treated with hydrocortisone presenting signs or symptoms of muscle weakness, especially in patients with hyperthyroidism.

If TPP is suspected, levels of blood potassium must be immediately monitored and adequately managed to ensure the restoration of normal levels of blood potassium. 8). Symptoms typically emerge within a few days or weeks of starting the treatment.

5 pharmacokinetic interactions that can increase the risk of side effects), 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 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), 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 […]

1. - Systemic fungal infections - patients with systemic infections (unless specific anti-infective therapy is employed) and - patients vaccinated with live vaccines.