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PREDNISOLONE is a brand name for Prednisolone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Prednisolone is a glucocorticoid (hydrocortisone and cortisone), which has anti- inflammatory, hormonal and metabolic effects; in addition they modify the body’s immune responses to divers stimuli. Indications are Allergy and anaphylaxis: Bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic…
Verbatim from this product's MHRA label. Tap a section to expand.
Adult:
Dosage may vary from 5mg to 60mg daily, initially, depending upon the disorder being treated. Preferably taken as a single dose in the morning, after breakfast. The tablets should be taken with a drink of water. The following therapeutic guidelines should be kept in mind for all therapy with corticosteroids: Corticosteroids are palliative symptomatic treatment by virtue of their anti- inflammatory effects; they are never curative.
Divided doses are usually used, the appropriate individual dose is determine by trial and error and must be re-evaluated regularly according to activity of the disease. As corticosteroid therapy becomes prolonged, and as the dose is increased, the incidence of disabling side-effects increases.
The initial dosage should be maintained or adjusted until the anticipated response is observed. The dose should then be gradually reduced until the lowest effective dose which will maintain an adequate clinical response, is reached.
4). When the drug is stopped it should be withdrawn gradually.
Intermittent dosage regimen:
A single dose of prednisolone tablets in the morning on alternative days or at longer intervals is acceptable therapy for some patients. When this regimen is practical, the degree of pituitary-adrenal suppression can be minimised.
Specific dosage guidelines:
The following recommendations for some corticosteroid- responsive disorders are for guidance only. Acute or severe disease may require initial high dose therapy with reduction to the lowest effective maintenance dose as soon as possible.
5mg daily during chronic treatment.
Allergic and skin disorders:
Initial dose of 5 – 15mg daily.
Collagenosis:
Initial doses of 20 – 30mg daily. Those with more severe symptoms may require higher doses.
Rheumatoid arthritis:
Usual initial dose is 10 – 15mg daily. The lowest daily maintenance dose compatible with tolerable symptomatic relief is recommended.
4).
Infections and infestations Not known:
Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis. 4) Blood and lymphatic system disorders Not known: Leucocytosis.
Increase in blood coagulability Immune system disorders Not known:
Hypersensitivity including anaphylaxis. Gastrointestinal disorders Not known: dyspepsia, nausea, peptic ulceration with perforation and haemorrhage, abdominal distension, abdominal pain, diarrhoea, oesophageal ulcers and oesophageal candidiasis, acute pancreatitis.
Musculo-skeletal and connective tissue disorders Not known: proximal myopathy, osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture, tendinopathies, myalgia, growth suppression in infancy, childhood and adolescence.
Skin and subcutaneous tissue disorders Not known: impaired healing, skin atrophy, bruising, striae, telangiectasia, acne, increased sweating, pruritis, rash and urticaria. Endocrine disorders Not known: suppression of hypothalamo-pituitary adrenal axis, growth suppression in infancy, childhood and adolescence, Cushingoid facies, hirsutism, impaired carbohydrate tolerance with increased requirement for antidiabetic therapy, manifestation of latent diabetes mellitus.
Metabolism and nutrition disorders Not known:
Sodium and water retention, hypokalaemic alkalosis, potassium loss negative nitrogen balance. Negative protein and calcium balance, glucose intolerance and protein catabolism. Increase both high and low density lipoprotein cholesterol concentration in the blood.
A patient information leaflet should be supplied with this product. Patients should carry “steroid treatment” cards which give clear guidance on the precautions to be taken to minimise risk and provide details of prescriber, drug, dosage and duration of treatment.
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. 2).
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 them or in their first degree relatives.
These would include depressive or manic-depressive illness and previous steroid psychosis. 8). Anti-Inflammatory/Immunosuppressive Effects Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity.
The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised. The immunosuppressive effects of glucocorticoids may result in activation of latent infection or exacerbation of intercurrent infections.
Prednisolone is contraindicated in patients with peptic ulcer, active tuberculosis, acute psychosis or systemic indication unless specific anti-infective therapy is employed. Hypersensitivity to any ingredients in the formulation. Patients with ocular herpes simplex due to the possibility of perforation.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose mal-absorption should not take this medicine.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Blood disorders and lymphoma:
An initial daily of 15 – 60mg is often necessary with reduction after an adequate clinical or haematological response, higher dose may be necessary to induce remission in acute leukaemia.
Special Populations Children:
Although appropriate fraction of the actual dose may be used, dosage will usually be determined by clinical response as in adults. Treatment should be limited to the minimum dosage for the shortest possible as a single dose on alternative days.
Children:
Aged 1-6 years- One quarter the adult dose. Aged 7-11 years- One half the adult dose. Aged 12-17 years- Three quarters the adult dose. Corticosteroids cause growth retardation in infancy, childhood and adolescence which may be irreversible.
Treatment should be limited to the minimum dosage for the shortest possible time. In order to minimise suppression of the hypothalamo-pituitary adrenal axis and growth retardation, treatment should be administered where possible as a single dose on alternate days.
4), especially osteoporosis, diabetes, hypertension, hypokalaemia, osteoporosis, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions. 5mg prednisolone or equivalent) for great than 3 weeks, withdrawal should not be abrupt.
How dose should be carried out depends largely on whether the disease is likely to relapse as the dose of systematic corticosteroids is reduced. Clinical assessment of disease activity may be needed during withdrawal of systemic corticosteroids but there is uncertainty about HPA suppression, the dose of systemic corticosteroids but there is uncertainty about HPA suppression, the dose of systemic corticosteroids may be reduced rapidly to physiological doses.
5mg of prednisolone 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 40mg daily of prednisolone or equivalent for 3 weeks is unlikely to lead to clinically relevant HDA-axis suppression, in the majority of patients. In the following patients groups, gradual withdrawal of systemic corticosteroids therapy should be considered even after courses lasting 3 weeks or less: -Patients who have had repeated courses of systematic 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 corticosteroids therapy, -Patients receiving doses of systemic corticosteroid greater than 40mg daily of prednisolone (or equivalent), -Patients repeatedly taking doses in the evening.
During prolonged therapy, dosage may need to be temporarily increased during period of stress or during exacerbation of the disease. Abrupt cessation of prolonged, high dosage of corticosteroid therapy is associated with a significant risk of potentially life-threatening adrenal insufficiency.
If there is a lack of satisfactory clinical response the drug should be gradually discontinued and the patient transfer to alternative therapy.
Increased appetite, weight gain, obesity, hyperglycaemia, dyslipidaemia.
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.
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; the frequency is unknown.
Not known: euphoria, psychological dependence, depression Nervous system disorders Not known: insomnia, dizziness, headache, intracranial hypertension in children, aggravation of schizophrenia, Increased intra-cranial pressure with papilloedema in children (pseudotumour cerebri), usually after treatment withdrawal.
Aggravation of epilepsy, epidural lipomatosis. vertebrobasilar stroke (exacerbation of giant cell arteritis, with clinical signs of evolving stroke has been attributed to prednisolone).
Eye disorders Not known:
Corneal or scleral thinning, exacerbation of ophthalmic viral or fungal disease, glaucoma, increased intra-ocular pressure, papilloedema, posterior subcapsular cataracts, nuclear cataracts (particular in children), exophthalmos. 4).
Ear and labyrinth disorders Not known: vertigo Cardiac disorders Not known:
Congestive heart failure in susceptible patients, hypertension, increased risk of heart failure. Increased risk of cardiovascular disease, including myocardial infarction (with high dose therapy).
Vascular disorders Not known:
Thromboembolism Reproductive system and breast disorders Not known: Menstrual irregularity, amenorrhoea. General disorders and administration site conditions Not known: fatigue, malaise and the suppression of delayed hypersensitivity reaction.
Rare: benign intracranial hypertension and psychic instability.
Investigations Not known:
Increased intra-ocular pressure, may suppress reactions to skin tests. 4). A steroid “Withdrawal Syndrome” seemingly unrelated to adrenocortical insufficiency may also occur following abrupt discontinuance of glucocorticoids. This syndrome includes symptoms such as: anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules, loss of weight and/or hypotension.
These effects are thought to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid levels. Psychological effects have been reported on withdrawal of corticosteroids. As prednisolone therapy becomes prolonged and as the dose is increased, the incidence of disabling side-effects increases.
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.
Chickenpox:
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 chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster and 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 special care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased.
Measles:
Patients are advised to take particular care avoid exposure to measles, immediate medical advice should be sought if exposure occurs. Prophylaxis with intramuscular normal immunoglobulin may be needed.
Tuberculosis:
Caution is necessary and frequent monitoring required when prescribing corticosteroids for patients with a history of tuberculosis or X-ray changes characteristic of tuberculosis. The emergence of active tuberculosis can be prevented by the prophylactic use of anti-tuberculosis therapy.
Administration of Live Vaccines:
Live vaccines should not be given to individuals on high doses of corticosteroids, due to impaired immune response. Live vaccines should be postponed until at least 3 months after stopping corticosteroid therapy. 5). The antibody response to other vaccines may be diminished.
5). Adrenocortical Insufficiency Pharmacologic doses of corticosteroids administered for prolonged periods may result in hypothalamic-pituitary-adrenal (HPA) suppression (secondary adrenocortical insufficiency). The degree and duration of adrenocortical insufficiency produced is variable among patients and depends on the dose, frequency, time of administration and duration of glucocorticoid therapy.
In addition, acute adrenal insufficiency leading to a fatal outcome may occur if glucocorticoids are withdrawn abruptly. Drug induced secondary adrenocortical insufficiency may therefore be minimized 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, hormone therapy should be reinstituted.
Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. During prolonged therapy an 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.
Special Precautions Caution is necessary when corticosteroids, including prednisolone, are prescribed to patients with the following conditions and frequent patient monitoring is necessary: • Diabetes mellitus or in those with a family history of diabetes.
• Glaucoma or in those with a family history of glaucoma. • Ocular herpes simplex […]