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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 primary, secondary or acute adrenocortical insufficiency. • Pre-operatively, and during serious trauma or illness in patients with known adrenal insufficiency or doubtful adrenocortical reserve.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Dosage must be individualized according to the response of the individual patient. The lowest possible dosage for the minimum period of time should be used. g. surgery, infection, trauma). During stress it may be necessary to increase the dosage temporarily.
If the drug is to be stopped after more than a few days of treatment, the dose should be reduced gradually over a period of weeks to months, depending on dosage and duration of therapy. In chronic adrenocortical insufficiency, a dosage of 20-30 mg a day is usually recommended, sometimes together with 4-6 g of sodium chloride or 50-300 micrograms of fludrocortisone daily.
, dexamethasone sodium phosphate), which may be effective within minutes after parenteral administration, can be life-saving. 8 mg/kg/day in two or three divided doses, adjusted to the needs of the individual child. 4). Method of administration For oral administration.
4). The following side effects may be associated with the long-term systemic use of corticosteroids. The frequencies of adverse events are ranked according to the following: very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1/1,000 to < 1/100), rare (≥1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Blood and lymphatic system disorders:
Not Known leucocytosis, thromboembolism. 4).
Metabolism and nutrition disorders:
Not known Sodium and water retention, hypertension, potassium loss, hypokalaemic alkalosis.
Psychiatric disorders:
Common 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), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported.
* Not known Psychological dependence. Nervous system disorders Not known Insomnia and aggravation of schizophrenia. Increased intracranial pressure with papilloedema in children (pseudotumour cerebri), usually after treatment withdrawal.
Aggravation of epilepsy.
Eye disorders:
Not known Increased intra-ocular pressure, glaucoma, papilloedema, posterior subcapsular cataracts, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal diseases.
Cardiac disorders:
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 recognised. 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. 4)). Tropical worm infections. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Not known Myocardial rupture following recent myocardial infarction. Hypertrophic cardiomyopathy in prematurely born infants.
Gastrointestinal disorders:
Not known Dyspepsia, peptic ulceration with perforation and haemorrhage, abnormal distension, oesophageal ulceration, candidiasis, acute pancreatitis, nausea and malaise.
Skin and subcutaneous tissue disorders:
Not known Cushingoid facies, hirsutism, weight gain, impaired carbohydrate tolerance with increased requirement for antidiabetic therapy, negative protein and calcium balance, and increased appetite, impaired healing, skin atrophy, bruising, striae, acne, telangiectasia Musculoskeletal and connective tissue disorders: Not known Proximal myopathy, osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture.
Renal and urinary disorders:
Not known Suppression of the hypothalamo-pituitary- adrenal axis, growth suppression in infancy, childhood and adolescence, menstrual irregularity and amenorrhoea.
General disorders and administration site conditions:
Not known Hypersensitivity, including anaphylaxis has been reported.
Investigations:
Not known Weight increased *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%. 4). A withdrawal syndrome may also occur including fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin modules 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 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.
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 or 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, muscular weakness, electrocardiographic changes, hypertension and untoward hormonal effects. Corticosteroids should be used with caution in patients with hypothyroidism.
Hypertrophic cardiomyopathy 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 3 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 of 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 3 weeks, is appropriate if it is considered that the disease is unlikely to relapse.
Abrupt withdrawal of doses of up to 160 mg hydrocortisone for three weeks is unlikely to lead to clinically relevant HPA-axis suppression, in the majority of patients. In the following patient groups, gradual withdrawal of systemic corticosteroid therapy should be considered even after courses lasting 3 weeks or less: • patients who have had repeated courses of systemic corticosteroids, particularly if taken for greater than 3 weeks; • when a short course has been prescribed within one year of cessation of long term therapy (months or years); • patients who may have reasons for adrenocortical insufficiency other than exogenous corticosteroid therapy • patients receiving doses of systematic corticosteroid greater than 160 mg hydrocortisone; • patients repeatedly taking doses in the evening Psychiatric adverse events Patients/and or carers should be warned that potentially severe psychiatric adverse reactions may […]