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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: Allergy and anaphylaxis: bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema, anaphylaxis Arteritis/ collagenosis: giant cell arteritis/ polymyalgia rheumatica, mixed connective tissue disease, polyarteritis nodosa, polymyositis Blood disorders: haemolytic anaemia (auto-immune),…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology 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.
The appropriate individual dose must be determined 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.
In general, initial dosage shall be maintained or adjusted until the anticipated response is observed. The dose should be gradually reduced until the lowest dose which will maintain an adequate clinical response is reached. Use of lowest effective dose may also minimise side-effects.
4). 5mg prednisolone 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 corticosteroid 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 up to 40mg daily of prednisolone or equivalent for 3 weeks is unlikely to lead to clinically relevant HPA-axis suppression, in the majority of the patients. 4) If there is lack of satisfactory clinical response to Prednisolone Tablets, the drug should be gradually discontinued and the patients transferred to alternative therapy.
Recommended doses and dose schedules Intermittent dosage regimen A single dose of prednisolone tablets in the morning on alternate 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.
The incidence of predictable undesirable effects, including hypothalamic- pituitary-adrenal suppression correlates with the relative potency of the drug, dosage, timing of administration and the duration of treatment. 4), oesophageal candidiasis.
Blood and lymphatic system disorders Not known Leucocytosis. Immune system disorders Not known Hypersensitivity including anaphylaxis has been reported. 4) Not known Sodium and fluid retention, hypokalaemic alkalosis, potassium loss, negative nitrogen and calcium balance, glucose intolerance and protein catabolism.
Increase both high and low density lipoprotein cholesterol concentration in the blood, hyperglycaemia, dyslipidaemia. Psychiatric disorders Common Irritability, depressed and labile mood, suicidal thoughts, psychotic reactions, mania, delusions, hallucinations, and aggravation of schizophrenia.
behavioural disturbances, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia. Not known Euphoria, depression, insomnia, psychological dependence. Nervous system disorders Not known Dizziness, headache.
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).
4) Not known Glaucoma, papilloedema, posterior subcapsular cataracts, corneal or scleral thinning, exophthalmos, exacerbation of ophthalmic viral or fungal diseases. 4). Ear and labyrinth disorders Not known Vertigo. Cardiac disorders Not known Congestive heart failure in susceptible patients, increased risk of heart failure.
Increased risk of cardiovascular disease, including myocardial infarction (with high dose therapy). Bradycardia (following high doses) Vascular disorders Not known Thromboembolism, hypertension. Gastrointestinal disorders Not known Dyspepsia, nausea, peptic ulceration with perforation and haemorrhage, abdominal distension, abdominal pain, diarrhoea, oesophageal ulceration, oesophageal candidiasis, acute pancreatitis Skin and subcutaneous tissue disorders Not known Hirsutism, skin atrophy, bruising, striae, telangiectasia, acne, increased sweating, pruritis, rash, urticaria.
A patient information leaflet should be supplied with this product. 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. Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives.
These would include depressive or manic-depressive illness and previous steroid psychosis and patients with systemic sclerosis because of possible risk of scleroderma renal crisis which can be fatal. 5). 8). Although calciphylaxis is most commonly observed in patients who have end stage kidney failure, it has also been reported in patients taking corticosteroids who have minimal or no renal impairment and normal calcium, phosphate and parathyroid hormone levels.
Patients/carers should be advised to seek medical advice if symptoms develop. Caution is necessary when oral corticosteroids, including Prednisolone Tablets, are prescribed in patients with the following conditions, and frequent patient monitoring is necessary.
- Tuberculosis: Those with a previous history of, or X-ray changes characteristic of, tuberculosis. The emergence of the active tuberculosis can, however be prevented by the prophylactic use of anti-tuberculosis therapy. - Inflammatory bowel disease: Symptoms recurred in a patient with Crohn's disease on changing from conventional to enteric-coated tablets of prednisolone.
Prednisolone tablets are contraindicated in patients who have systemic infection unless specific anti-infective therapy is employed. 1. - Prednisolone tablets are contraindicated in patients with ocular herpes simplex because of possible perforations.
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5mg daily during chronic treatment.
Allergic and skin disorders:
Initial doses of 5-15mg daily are commonly adequate.
Collagenosis:
Initial doses of 20-30mg daily are frequently effective. Those with more severe symptoms may require higher doses.
Rheumatoid arthritis:
The usual dose is 10-15 mg daily. The lowest daily maintenance dose compatible with tolerable symptomatic relief is recommended.
Blood disorders and lymphoma:
An initial daily dose of 15-60mg is often necessary with reduction after an adequate clinical or haematological response. Higher doses may be necessary to induce remission in acute leukaemia.
Adults:
The initial dosage of Prednisolone Tablets may vary from 5 mg to 60 mg daily depending on the disorder being treated. Alternatively, it may be given as a single dose in the morning after breakfast or as a double dose on alternate days.
5 – 15 mg daily, but higher doses may be needed. Alternate day therapy is the dosage regime of choice for long-term oral glucocorticoid therapy if disease controls allows. 00 am to provide relief of symptoms whilst minimising adrenal suppression, protein catabolism and other adverse effects.
Alternate day therapy is not appropriate for patients with established adrenal insufficiency. 4). Not normally recommended (owing to the adverse effect on growth), but the following may be used as a guide where treatment is considered essential.
Where possible administration should take place on alternate days as a single dose.
Over 12 years:
Three quarters of the adult dose.
Over 7 years:
One half of the adult dose.
Over 1 year:
One quarter of the adult dose. 4). Method of administration For oral administration
Musculoskeletal and connective tissue disorders Not known Proximal myopathy, osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture, tendinopathies (particularly of the Achilles and patellar tendons), myalgia, growth suppression in infancy, childhood and adolescence.
Renal and urinary disorders Not known Scleroderma renal crisis (see under Description of selected adverse reactions) Reproductive system and breast disorders Not known Menstrual irregularity, amenorrhoea. General disorders and administration site conditions Not known Impaired healing, fatigue and malaise.
Investigations Not known Increased intra-ocular pressure, may suppress reactions to skin tests. 2) 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 and loss of weight and/or hypotension.
These are thought to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid levels. 5 mg prednisolone 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 HPA suppression, the dose of systemic corticosteroids may be reduced rapidly to physiological doses.
5 mg 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 three weeks is appropriate if it is considered that the disease is unlikely to relapse.
Abrupt […]
This was not an isolated occurrence in the author's unit, and it was advocated that only non-enteric coated prednisolone tablets should be used in Crohn's disease, and that the enteric coated form should be used with caution in any condition characterized by diarrhoea or a rapid transit time.
- Hypertension - Congestive heart failure - Liver failure - Hepatic disease: In patients with acute and active hepatitis, protein binding of the glucocorticoids will be reduced and peak concentrations of administered glucocorticoids increased.
There is an enhanced effect of corticosteroids in patients with cirrhosis. - Renal insufficiency - Diabetes mellitus (or a family history of diabetes) - Osteoporosis (post-menopausal females are particularly at risk) - Corticosteroid requirements may be reduced in menopausal and post-menopausal women.
- Patients with a history of severe affective disorders and particularly those with a previous history of steroid-induced psychoses. - Also existing emotional instability or psychotic tendencies may be aggravated by corticosteroids including Prednisolone.
- Epilepsy, and/or seizure disorders. - Peptic ulceration. - Previous steroid myopathy. - Glucocorticoids should be used cautiously in patients with myasthenia gravis receiving anticholinesterase therapy. - Because cortisone has been reported rarely to increase blood coagulability and to precipitate intravascular thrombosis, thromboembolism, and thrombophlebitis, corticosteroids should be used with caution in patients with thromboembolic disorders.
- Duchenne’s muscular dystrophy: transient rhabdomyolysis and myoglobinuria may occur following strenuous physical activity. It is not known whether this is due to Prednisolone itself or the increased physical activity. - Glaucoma (or a family history of glaucoma) - Previous corticosteroid-induced myopathy 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.
5 mg daily. 2).
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 any intercurrent illness, trauma or surgical […]