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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, incapacitating allergies unresponsive to conventional treatment. Arteritis/collagenosis: Giant cell arteritis/polymyalgia rheumatica, mixed connective tissue disease, polyarteritis nodosa,…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults and the elderly The lowest effective dose should be used for the minimum period. Children Prednisolone should only be used when specifically indicated, at the lowest dose possible and for the shortest possible time. The initial dosage of prednisolone may vary from 5 mg to 60 mg daily depending on the disorder being treated.
Divided daily dosage is usually used. Administration as a once daily dose in the morning or on alternate days can reduce the risk of adrenocortical suppression (see Section
Apart from substitution therapy, corticosteroid treatment always involves an overdose compared to the physiological state. Side effects mainly occur with long-term treatment, but also depend on dose size and individual sensitivity. Undesirable effects are listed by MedDRA System Organ Classes.
, tuberculosis) Blood and lymphatic system disorders Not known leucocytosis (due to redistribution of intravascular granulocytes). Immune system disorders Not known drug hypersensitivity, anaphylactic reaction, anaphylactoid reaction.
Endocrine disorders Common inhibition of the hypothalamicpituitary- adrenal (HPA) axis, cushing-like symptoms. 4).. Common hypokalaemia, sodium retention, increased gluconeogenesis, catabolic effects, osteoporosis Metabolism and nutrition disorders Not known metabolic acidosis, fluid retention, hypokalaemic alkalosis, reduced glucose intolerance (diabetes mellitus may deteriorate and latent diabetes become manifest) .
lipomatosis, Increased appetite(Which weight gain) dyslipidaemia. Uncommo n activation of previous mental disorders (high dose) Rare depression, mania in patients without previously known mental illness Psychiatric disorders Not known affective disorder (includes euphoria, affective lability, drug-related, suicidal condition), psychotic disorder (includes delusions, hallucinations and schizophrenia) mental illness, , personality change, mood swings, abnormal behaviour, insomnia, irritability.
Rare Benign intracranial hypertensionNervous system disorders Not known amnesia, Cognitive disorder, dizziness, headache, epidural lipomatosis. 4) exophthalmos, Cardiac disorders Not known congestive heart failure in susceptible patients, bradycardia ** Common oedema hypertensionVascular disorders Not known thromboembolism events.
Respiratory, thoracic and mediastinal disorders Not known hiccup Gastrointestinal disorders Not known dyspepsia, nausea, peptic wound (possibly with perforation and bleeding), abdominal distension, abdominal pain, diarrhoea, oesophageal ulceration, intestinal perforation pancreatitis.
). g. patients with rheumatoid arthritis with pronounced morning stiffness where an evening dose may need to be given. The following therapeutic guidelines should be kept in mind for all therapy with corticosteroids: The lowest dose to produce an acceptable result should be given.
Initial dosage should be adjusted until the desired clinical response has been achieved . The dose should be gradually reduced until the lowest dose which will maintain an adequate clinical response is reached. 5 – 5 mg every second to fifth day (more rapidly at the higher initial dose levels) until the lowest possible maintenance dose is reached.
Preferably this should not exceed 10 mg per day. 4). 5mg prednisolone daily or equivalent for more than 3 weeks, owing to a greater risk of suppression of the hypothalamic-pituitary-adrenal (HPA) axis in these patients. The speed with which dose can be reduced is also dependent on risk of relapse of the disease being treated.
5 mg (regarded as “equivalent” to physiological levels of glucocorticoids) should be conducted particularly cautiously.. More rapid withdrawal of systemic corticosteroid treatment hat has been given for less than3 weeks is appropriate if it is considered that the disease is unlikely to relapse.
Withdrawal of doses of up to 40mg daily of prednisolone, or equivalent have been administered for less than 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.
1. 1. 2. Systemic yeast infection 3. Administration of live vaccines is contraindicated in patients receiving corticosteroids immunosuppressive doses. 4. In those conditions when treatment with prednisolone can save lives, none of the contraindications generally apply.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Skin and Common skin atrophy, impaired wound healing subcutaneous tissue disorders Not known angioedema, hirsutism, petechiae, ecchymosis, erythema hyperhidrosis, stretch marks, itching, acne, urticaria. Common muscular atrophy Rare aseptic bone necrosis, tendon rupture Musculoskeletal and connective tissue disorders Not known muscle weakness, myalgia, neuropathing arthropathy, arthralgia, myopathy, pathological fracture Renal and urinary disorders Not know scleroderma renal crisis* Reproductive system and breast disorders Not known menstrual irregularity, General disorders and administration site conditions Not known fatigue, malaise, Investigations Not known Increased calcium levels in the urine, Elevated alanine aminotransferase, Elevated aspartate aminotransferase, Increased blood alkaline phosphatase, Elevated blood urea, suppression of skin tests reactions1.
1 Not MedDRA term *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%) ** Following high doses 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 MHRA Yellow Card in the Google Play or Apple App Store.
• patients receiving doses of systemic corticosteroid greater than 40mg daily of prednisolone (or equivalent). • patients repeatedly taking doses in the evening. 4 'Special warnings and special precautions for use') If there is lack of a satisfactory clinical response to Prednisolone Tablets, the drug 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. Method of administration Prednisolone tablets should be taken following a meal to reduce the risk of gastric irritation.
3 Contraindications 1. 1. 2. Systemic yeast infection 3. Administration of live vaccines is contraindicated in patients receiving corticosteroids immunosuppressive doses. 4. In those conditions when treatment with prednisolone can save lives, none of the contraindications generally apply.
. 4 Special warnings and precautions for use Since the complications of glucocorticoid therapy are dependent on the dose and duration of treatment, a risk / benefit assessment must be made in each case regarding dose and duration of treatment, as well as whether daily or intermittent treatment should be used.
The lowest possible corticosteroid dose needed to control the disease being treated should be used. When dose reduction is possible, it should be gradual.
Immunosuppressive effects/ increased susceptibility to infection:
Glucocorticoids, including prednisolone, may cause increased susceptibility to infection, masking symptoms of infection, and new infections may occur during treatment. Infections caused by viruses, bacteria, fungi, protozoa or intestinal worms may be associated with the use of corticosteroids alone or corticosteroids in […]