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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.
These tablets are for oral administration only. The initial dose may vary up to 60 mg daily depending on the disorder being treated, taken in the morning after food. 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.
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, the initial dose should be maintained or adjusted until the anticipated response is noted. The dose should be gradually reduced until the lowest dose which will maintain an adequate clinical response is reached. 4). The 1 mg tablets are normally used to help adjust doses during titration procedures and for maintenance therapy.
5 mg 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 systemic corticosteroid may be reduced rapidly to physiological doses.
5 mg 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 40 mg daily of prednisolone, or equivalent for 3 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 systemic corticosteroid greater than 40 mg daily of prednisolone (or equivalent), • patients repeatedly taking doses in the evening.
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.
4). Undesirable effects are listed by MedRA System Organ Classes.
Assessment of undesirable effects is based on the following frequency groupings:
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 System Organ Class Frequency Undesirable Effect Infections and infestations Not known Increases susceptibility to, and severity of infections1, opportunistic infections, recurrence of dormant tuberculosis2, oesophageal candidiasis.
Blood and lymphatic system disorders Not known Leucocytosis. Immune system disorders Not known Hypersensitivity including anaphylaxis. Endocrine disorders Not known Suppression of the hypothalamo-pituitary adrenal axis3, cushingoid facies, 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 and calcium balance, glucose intolerance and protein catabolism. Increase both high and low density lipoprotein cholesterol concentration in the blood.
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 on alternate days. 2). 8). 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 systematic steroids, although such reactions have been reported infrequently.
Particular care is required when considering the use of systematic corticosteriods 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.
8). Anti-Inflammatory/Immunosuppressive Effects Suppression of the inflammatory response and immune function increases the susceptibility of 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 advance stage before being recognised.
The immunosuppresive effects of glucocorticoids may result in activation of latent infection or exacerbation of intercurrent infections.
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.
• Systemic infections, unless specific anti-infective therapy is used. 1). • Ocular herpes simplex because of possible perforation. • 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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4. 4). If there is a lack of a satisfactory clinical response prednisolone should be gradually discontinued and the patient transferred to alternative therapy. 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.
5 mg daily during chronic treatment. Allergic and skin disorders Initial doses of 5-15 mg daily are commonly adequate. Collagenosis Initial doses of 20-30 mg daily are frequently effective. Those with more severe symptoms may require higher doses.
Rheumatoid arthritis The usual initial 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 15-60 mg is often necessary with reduction after an adequate clinical or haematological response.
Higher doses may be necessary to induce remission in acute leukaemia. 4). 8). Alternate day dosage is preferable where possible.
Increased appetite4. Weight gain, obesity, hyperglycaemia, dyslipidaemia. 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.
Psychiatric disorders Not known Euphoria, psychological dependence, depression. Nervous system Not known Depression, insomnia, dizziness, disorders headache, vertigo. Raised intracranial pressure with papilloedema (pseudotumor cerebri)5.
Aggravation of epilepsy, epidural lipomatosis. vertebrobasilar stroke6. Eye disorders Not known Glaucoma, papilloedema, posterior subcapsular cataracts, nuclear cataracts (particularly in children), exophthalmos, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal disease.
7 Ear and labyrinth disorders Not known Vertigo. Cardiac disorders Not known Congestive heart failure in susceptible patients, hypertension, increased risk of heart failure. 8 Bradycardia* Vascular disorders Not known Thromboembolism.
Gastrointestinal disorders Not known Dyspepsia, nausea, peptic ulceration with perforation and haemorrhage, abdominal distension, abdominal pain, diarrhoea, oesophageal ulceration, acute pancreatitis. Skin and subcutaneous tissue disorders Not known Hirsutism, skin atrophy, bruising, striae, telangiectasia, acne, increased sweating, pruritis, rash, urticaria.
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* Reproductive system and breast disorders Not known Menstrual irregularity, amenorrhoea. General disorders and administration site conditions Not known Fatigue, malaise, impaired healing.
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 weight loss, 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. *Description of selected adverse reactions Scleroderma renal crisis Amongst the different subpopulations the occurrence of scleroderma renal crisis varies. The highest risk has been reported in patients with diffuse systemic sclerosis.
The lowest risk has been reported in patients with limited systemic sclerosis (2%) and juvenile onset systemic sclerosis (1%) Reporting of suspected adverse reactions Reporting […]
Passive immunisation with varicella/zoster immunogloblin (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.
Measles:
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.
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 may, however, be prevented by 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.
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. Special Precautions Caution is necessary when oral corticosteroids, including prednisolone tablets, are prescribed in patients with the following conditions and frequent patient monitoring is necessary: • Osteoporosis; this is of special importance in post-menopausal females, who are particularly at risk • Menopausal or post-menopausal women: corticosteroid requirements may be reduced.
• Hypertension. • Congestive heart failure. […]