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HYDVENTIA is a brand name for Hydrocortisone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Corticosteroid Hydrocortisone Tablets are indicated 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. • replacement therapy in congenital…
Verbatim from this product's MHRA label. Tap a section to expand.
Method of Administration For oral administration. Posology Dosage must be individualised according to the response of the individual patient. The lowest possible dosage should be used. 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. 4). Replacement therapy In chronic adrenocortical insufficiency, a dosage of 20 to 30mg a day is usually recommended, sometimes together with 4-6 g of sodium chloride or 50-300 micrograms of fludrocortisone daily.
g. dexamethasone sodium phosphate), which may be effective within minutes after parenteral administration, can be life-saving. 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. 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. Acute emergencies 60-80 mg every 4-6 hours for 24 hours then gradually reduce the dose over several days.
4). 4).
4). Adverse events 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 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).
The following side effects may be associated with the long-term systemic use of corticosteroids. System organ class Frequency Undesirable effects Infections and infestations Not known Gastroenteritis Upper respiratory tract infection Viral infection.
4), activation of fungal and viral infections including herpes Blood and lymphatic system disorders Not known Leukocytosis Immune system disorders Not known Hypersensitivity, anaphylaxis Endocrine disorders Not known Suppression of the hypothalamo-pituitary-adrenal axis Growth retardation in infancy, childhood and adolescence.
4). Ear and labyrinth disorders Not known Vertigo Cardiac disorders Not known Myocardial rupture following recent myocardial infarction Congestive heart failure in susceptible patients Hypertrophic cardiomyopathy in prematurely born infants Vascular disorders Not known Hypertension Thromboembolism Respiratory, thoracic and mediastinal disorders Not known Hiccups Gastrointestinal disorders Not known Dyspepsia Peptic ulceration with perforation and haemorrhage Perforation of the small and large bowel particularly in patients with inflammatory bowel disease Deterioration of existing gastric ulcer Abdominal distension Oesophageal ulcer Oesophagitis Upper abdominal pain Tooth erosion Candidiasis Acute pancreatitis and Nausea Skin and subcutaneous tissue disorders Not known Impaired healing Skin atrophy Contusion Petechiae and ecchymosis Erythema Skin striae Rash pruritic Cushing-like symptoms Acne Increased sweating Telangiectasia Hirsutism 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 Loss of muscle mass Proximal myopathy Osteoporosis and spontaneous fractures Vertebral and long bone fractures Avascular osteonecrosis Tendon rupture and Joint swelling Reproductive system and breast disorders Not known Menstruation irregular and amenorrhoea General disorders and administration site conditions Not known Malaise Fatigue Investigations Not known Weight increased High density lipoprotein decreased Blood potassium decreased (a) Reactions are common and may occur in both adults and children.
A patient information leaflet should be supplied with this product. 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. The patient must be carefully informed how to act in these situations and also advised to immediately seek medical attention should an acute deterioration occur; especially in cases of gastroenteritis, vomiting and/or diarrhoea leading to fluid and salt loss, as well as to inadequate absorption of oral hydrocortisone.
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. Corticosteroids may mask some signs of infection and some serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised.
The clinical presentation can often be atypical and there may be an inability to localise infection in patients on corticosteroids. Corticosteroids may affect the nitroblue tetrazolium test for bacterial infection and produce false negative results.
New infections may appear during their use. Chickenpox is of particular concern since this normally minor illness may be fatal in immunosuppressed patients. Patients (or parents of children) without a definite history of chickenpoxshould be advised to avoid close personal contact with chickenpox or herpes zoster and if exposed they should seek urgent medical attention.
Hydrocortisone Tablets are contraindicated in patients with known hypersensitivity to any of the ingredients. They are also contraindicated in patients with systemic infections (unless specific anti-infective therapy is employed) and in patients vaccinated with live vaccines.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In adults, the frequency of severe reactions has been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids and psychological dependence has occurred; the frequency is not known. 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 is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. uk/yellowcard.
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. Patients with concomitant adrenal insufficiency and retroviral infection, such as HIV, need careful dose adjustment due to potential interaction with antiretroviral medicinal products and increased hydrocortisone dose due to the infection.
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. 9%) solution for injection, must be given.
Using higher than normal (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.
Particular care is required when prescribing systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary: • osteoporosis (postmenopausal females are particularly at risk). All glucocorticoids increase calcium excretion and reduce the bone-remodelling rate.
Patients with adrenal insufficiency on long-term glucocorticoid replacement therapy have been found to have reduced bone mineral density; • hypertension or congestive heart failure; • recent myocardial infarction; • existing or previous history of severe affective disorders (especially previous history of steroid psychosis); • diabetes mellitus (or a family history of diabetes); • latent tuberculosis, or tuberculin reactivity, close observation is necessary as reactivation may occur.
During prolonged corticosteroid therapy, these patients should receive prophylactic use of anti-tuberculoustherapy. The use of hydrocortisone tablets in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis.
• glaucoma (or family history or glaucoma). Prolonged use of high doses of glucocorticoids may produce posterior subcapsular cataracts, and glaucoma with possible damage to the optic nerves. Such effects have not been reported in patients receiving replacement therapy with glucocorticoids in doses used in adrenal insufficiency; • previous corticosteroid-induced myopathy; • liver failure; • renal insufficiency, chronic nephritis, acute glomerulonephritis; • epilepsy; • peptic ulceration, diverticulitis, fresh intestinal anastomoses • non-specific ulcerative colitis.
• thrombophlebitis • exanthematous disease; • metastatic carcinoma • myasthenia gravis • Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation.
Fat embolism has been reported as a possible complication of hypercortisonism. There is an enhanced effect of […]