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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 5mg to 60mg daily depending on the disorder being treated.
Divided daily dosage may be 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. The following side effects have been observed and reported during treatment with Prednisolone at the following frequencies: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data).
, tuberculosis) Blood and lymphatic system Leukocytosis (due to redistribution of intravascular granulocytes) Immune system disorders Drug hypersensitivity Anaphylactic reaction Anaphylactoid reaction Endocrine Inhibition of the Steroid withdrawal disorders hypothalamic- pituitary-adrenal (HPA) axis, Cushing-like symptoms.
4) Cardiac disorders Heart failure (in sensitive patients) Bradycardia** Vascular disorders Oedema hypertension Thromboembolic events Respiratory, thoracic and mediastinal disorders Hiccup Gastrointestinal disorders Peptic wound (possibly with perforation and bleeding) Intestinal perforation pancreatitis Ulcerative esophagitis abdominal distension Abdominal pain Diarrhoea Dyspepsia Nausea Skin and subcutaneous tissue disorders Skin atrophy Impaired wound healing Angioedema Hirsutism Petechiae Ecchymosis Erythema hyperhidrosis Stretch marks Itching Urticaria Acne Musculoskeletal and connective tissue disorders Muscular Atrophy Aseptic bone necrosis Tendon rupture Muscle weakness Myalgia Myopathy Pathological fracture Neuropathic arthropathy Arthralgia Renal and urinary disorders Acute renal crisis (renal crisis in scleroderma) * Reproductive system and breast disorders Irregular menstruation General disorders and administration site conditions Fatigue Malaise Investigations Increased calcium levels in the urine Elevated alanine aminotransferase Elevated aspartate aminotransferase Increased blood alkaline phosphatase Elevated blood urea Suppression of skin test reactions1 1 Not MedDRA term.
). 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. Use of the lowest effective dose will tend to minimise side-effects. 4 'Special warnings and special precautions for use'). 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 that has been given for less than 3 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 that 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. • patients receiving doses of systemic corticosteroid greater than 40mg daily of prednisolone (or equivalent).
1. Systemic yeast infection. Administration of live vaccines is contraindicated in patients receiving corticosteroids in immunosuppressive doses. In those conditions when treatment with prednisolone can save lives, none of the contraindications generally apply.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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* Acute renal crisis (scleroderma renal crisis) The incidence of acute renal crisis varies between the different subpopulations. The greatest risk has been reported in patients with diffuse systemic sclerosis. The minimum risk has been reported in patients with limited systemic sclerosis (2%) and systemic sclerosis with juvenile onset (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.
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• 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 PrednisoloneTablets 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.
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 initial dose is 10-15mg 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. Special populations Use in elderly Treatment of elderly patients, particularly if long-term, should be undertaken with caution bearing in mind the more serious consequences of the common side-effects of corticosteroids in old age (see also 'Special warnings and special precautions for use').
8 'Undesirable effects'). 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. 1. Systemic yeast infection. Administration of live vaccines is contraindicated in patients receiving corticosteroids in immunosuppressive doses.
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 […]