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GENHYCO is a brand name for Hydrocortisone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Replacement therapy of adrenal insufficiency in adults, children and adolescents < 18 years of age.
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. The lowest possible dosage should be used. To simulate the normal diurnal rhythm of cortisol secretion, the first dose in the morning should be higher than the other doses.
, surgery, infection, trauma). During stress it may be necessary to increase the dosage temporarily. 4). Adults A dosage of 15-30 mg a day, typically in two to three daily doses, is usually recommended. In patients with some remaining endogenous cortisol production a lower dose may be sufficient.
Pre-operatively, during serious trauma or illness in patients with known adrenal insufficiency or doubtful adrenal reserve Pre-operatively, anaesthetists must be informed if the patient is taking corticosteroids or has previously taken corticosteroids.
In less severe situations when parenteral administration of hydrocortisone is not required, for instance low grade infections, moderate fever of any aetiology and stressful situations such as minor surgical procedures, there should be high awareness of the risk of developing acute adrenal insufficiency, and the normal oral daily replacement dose should be increased temporarily; the hydrocortisone total daily dose should be increased by doubling or tripling the usual dose.
Once the intercurrent illness episode is over, patients can return to the normal replacement dose of hydrocortisone. In severe situations, an increase in dose is immediately required and oral administration of hydrocortisone must be replaced with parenteral treatment.
Parenteral administration of hydrocortisone is warranted during transient illness episodes such as severe infections, in particular gastroenteritis associated with vomiting and/or diarrhoea, high fever of any aetiology or extensive physical stress, such as for instance serious accidents and surgery under general anaesthesia.
Where parenteral hydrocortisone is required, the patient should be treated in a facility with resuscitation facilities in case of evolving adrenal crisis. Special populations Paediatric population Recommended replacement doses of hydrocortisone are 8-10 mg/m2/day for patients with adrenal insufficiency alone and 10-15 mg/m2/day in patients with congenital adrenal hyperplasia, typically in three or four divided doses.
Summary of safety profile Hydrocortisone is given as replacement therapy aimed at restoring normal cortisol levels. The adverse reaction profile in the treatment of adrenal insufficiency is therefore not comparable to that in other conditions requiring much higher doses of oral or parenteral glucocorticoids.
4). Tabulated list of adverse reactions The following adverse reactions have been reported in the scientific literature in adult patients for other hydrocortisone medicinal products when given as adrenal insufficiency replacement therapy with frequency not known (cannot be estimated from the available data).
MedDRA system organ class Frequency: not known Psychiatric disorders Psychosis with hallucinations and delirium Mania Euphoria Gastrointestinal disorders Gastritis Nausea Renal and urinary disorders Hypokalaemic alkalosis It is known that the use of glucocorticoids at higher doses and for indication other than replacement therapy for adrenal insufficiency can lead to the following side effects (frequencies not known): Immune system disorders Activation of an infection (tuberculosis, fungal and viral infections including herpes), hypersensitivity.
Endocrine disorders Induction of glucose intolerance or diabetes mellitus. Metabolism and nutrition disorders Salt and water retention leading to oedema, hypertension, hypokalaemia. Psychiatric disorders Euphoria, psychosis, insomnia.
Eye disorders Increased intraocular pressure and cataracts. Gastrointestinal disorders Dyspepsia and worsening of a pre-existing ulcer. Skin and subcutaneous tissue disorders Cushing-like symptoms, stretch marks, ecchymosis, acne and hirsutism, impaired wound healing.
Musculoskeletal and connective tissue disorders Osteoporosis with spontaneous fractures and muscle weakness. Paediatric population Hydrocortisone has been used for more than 60 years in paediatrics with a safety profile similar to that in adults.
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. Adrenal crisis Acute adrenal insufficiency may develop in patients with known adrenal insufficiency who are on inadequate daily doses or in situations with increased cortisol need.
Therefore, patients should be advised of the signs and symptoms of acute adrenal insufficiency and of adrenal crisis and the need to seek immediate medical attention. Sudden discontinuation of therapy with hydrocortisone risks triggering an adrenal crisis and death.
When a patient is vomiting or acutely unwell, parenteral hydrocortisone should be started without delay. The patient and one or more responsible family or household members should be trained in administering this in an emergency. 9%) solution for infusion, should be administered according to current treatment guidelines.
Drug-induced secondary adrenocortical insufficiency may result from too rapid a withdrawal of corticosteroids and may be minimised by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, corticosteroid therapy should be reinstated.
If the patient is receiving steroids already, the dosage may have to be increased. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms including fever, myalgia, arthralgia, and malaise. This may occur in patients even without evidence of adrenal insufficiency.
Infections and immunisation Replacement schedules of corticosteroids for people with adrenal insufficiency do not cause immunosuppression and therefore administration of live vaccines is not contraindicated. 2). Patients with adrenal insufficiency are at risk of life-threatening adrenal crisis during infection so clinical suspicion of infection should be high and specialist advice should be sought early.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In patients with some remaining endogenous cortisol production a lower dose may be sufficient. Appropriate strength of formulation should be chosen based on the prescribed dose and appropriate formulation should be chosen based on the child’s capability to swallow and availability of formulations.
For patients unable to swallow tablets, other pharmaceutical forms are available and may be more appropriate. Elderly (≥ 65 years old) Treatment of elderly patients, particularly if long term, should be planned to bear 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 case of an age-related low body weight, it is recommended to monitor the clinical response as dose adjustment may be required. Renal impairment There is no need for dosage adjustment in patients with mild to moderate renal impairment.
2. Hepatic impairment There is no need for dose adjustment in mild to moderate hepatic impairment. In case of severe hepatic impairment, the functional liver mass decreases and thus the metabolising capacity for hydrocortisone. 2. Method of administration For oral administration.
4) - it is unclear if these relate to hydrocortisone therapy using current replacement regimens. 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 the MHRA Yellow Card in the Google Play or Apple App Store.
Undesirable effects of corticosteroid replacement therapy Most undesirable effects of corticosteroids are dose and duration of exposure related. Undesirable effects are therefore less likely when using corticosteroids as replacement therapy.
In all patients suffering from adverse events under- and/or overdosing should be considered, and prescribers are encouraged to investigate the cause of the undesirable effects and increase or decrease the dose. High (supra-physiological) dosages of hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.
Long-term treatment with higher than physiological hydrocortisone doses can lead to clinical features resembling Cushing’s syndrome with increased adiposity, abdominal obesity, hypertension and diabetes, and thus result in an increased risk of cardiovascular morbidity and mortality.
Patients should be warned of the signs of diabetes and the need to seek medical advice if they occur. All glucocorticoids increase calcium excretion and reduce the bone-remodelling rate. 8). The lowest appropriate dose of steroid according to the response of the individual patient should be used.
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.
Corticosteroids may cause growth retardation in childhood and adolescence; this may be irreversible. Treatment should be limited to the minimum dose required to achieve desired clinical response and when reduction in dose is possible, the reduction should be gradual.
Excessive weight gain with decreased height velocity or other symptoms or signs of Cushing syndrome indicate excessive glucocorticoid replacement. Children require frequent assessment to assess growth, blood pressure, and general well-being.
8). Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Thyroid function Patients with adrenal insufficiency should be monitored for thyroid dysfunction as both hypothyroidism and hyperthyroidism may […]