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HYDROCORTISONE is a brand name for Hydrocortisone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Corticosteroid • For use as replacement therapy in congenital adrenal hyperplasia in children. • Pre-operatively, and during serious trauma or illness in children with known adrenal insufficiency or doubtful adrenocortical reserve.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Dosage must be individualised according to the response of the individual patient. 8mg/kg/day in two or three divided doses, adjusted to the needs of the individual child. 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).
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.
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.
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, abnormal 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.
Adrenal suppression Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. Withdrawal of corticosteroids after prolonged therapy must therefore always be gradual to avoid acute adrenal insufficiency, being tapered off over weeks or months according to the dose and duration of treatment.
During prolonged therapy, any intercurrent illness, trauma or surgical procedure will require a temporary increase in dosage. If corticosteroids have been stopped following prolonged therapy, they may need to be temporarily re-introduced.
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. Anti-inflammatory / immunosuppressive effects and infection Suppression of inflammatory response and immune function increases the susceptibility to infections and their severity.
The clinical presentation can often be atypical and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognized. New infections may appear during their use. Corticosteroids may activate latent amoebiasis or strongyloidiasis or exacerbate active disease.
Therefore it is recommended that latent or active amoebiasis and strongyloidiasis be ruled out before initiating corticosteroid therapy in any patient at risk of or with symptoms suggestive of either condition. 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.
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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
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. Corticosteroids should not be stopped and the dose may need to be increased. 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 be used with caution in non-specific ulcerative colitis if there is a probability of impending perforation, abscess or other pyogenic infection, diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer.
Particular care is required when prescribing systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary: a) osteoporosis (postmenopausal females are particularly at risk); b) hypertension or congestive heart failure; c) existing or previous history of severe affective disorders (especially previous history of steroid psychosis); d) diabetes mellitus (or a family history of diabetes); e) previous history of tuberculosis or characteristic appearance on a chest x- ray.
The emergence of active tuberculosis can, however, be prevented by the prophylactic use of anti-tuberculous therapy; f) glaucoma (or family history of glaucoma); g) previous corticosteroid-induced myopathy; h) liver failure; i) renal insufficiency; j) epilepsy; k) peptic ulceration; l) recent myocardial infarction.
During treatment, the patient should be observed for psychotic reactions, weakness, electrocardiographic changes, hypertension and untoward hormonal effects. Corticosteroids should be used with caution in patients with hypothyroidism.
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.
Paediatric population:
Corticosteroids cause growth retardation in infancy, childhood and adolescence; this may be irreversible. 2). Hypertrophic cardiomyopathy was reported after administration of hydrocortisone to prematurely born infants, therefore appropriate diagnostic evaluation and monitoring of cardiac function and structure should be performed.
Withdrawal symptoms:
In patients who have received more than physiological doses of systemic corticosteroids (approximately 40 mg cortisone or equivalent) for greater than three weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as the dose of systemic corticosteroids is reduced.
Clinical assessment of disease activity may be needed during withdrawal. If the disease is unlikely to relapse on withdrawal of systemic corticosteroids but there is uncertainty about hypothalamic-pituitary adrenal (HPA) suppression, the dose of systemic corticosteroid may be reduced rapidly to physiological doses.
Once a daily dose equivalent to 30 mg hydrocortisone is reached, dose reduction should be slower to allow the HPA-axis to recover. Abrupt withdrawal of systemic corticosteroid treatment, which has continued up to three weeks, is appropriate if it is considered that the disease is unlikely to relapse.
Abrupt […]