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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: A wide variety of diseases may sometimes require corticosteroid therapy. Some of the principal indications are: • bronchial asthma, severe hypersensitivity reactions, anaphylaxis, rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease (excluding systemic sclerosis),…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The lowest dosage that will produce an acceptable result should be used (See precautions sections); when it is possible to reduce the dosage, this must be accomplished by stages. During prolonged therapy any 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.
Adult:
The dose used will depend upon the disease, its severity, and the clinical response obtained. The following regimens are for guidance only. Divided dosage is usually employed. 5 or 5 mg every two to five days, depending upon the response.
5 to 10mg daily. For maintenance therapy the lowest effective dosage is used. Most other conditions: 10 to 100mg daily for one to three weeks, then reducing to the minimum effective dosage. g. 75% at 12 years, 50% at 7 years and 25% at 1 year) but clinical factors must be given due weight.
Prednisolone Tablets may be given early in the treatment of acute asthma attacks in children. For children over 5 years use a dose of 30-40mg prednisolone. For children aged 2-5 years use a dose of 20mg prednisolone. Those already receiving maintenance steroid tablets should receive 2 mg/kg prednisolone up to a maximum dose of 60mg.
The dose of prednisolone may be repeated for children who vomit; but intravenous steroids should be considered in children who are unable to retain orally ingested medication. Treatment for up to three days is usually sufficient, but the length of course should be tailored to the number of days necessary to bring about recovery.
There is no need to taper the dose at the end of treatment. For children under 2 years, Prednisolone Tablets can be used early in the management of moderate to severe episodes of acute asthma in the hospital setting, at a dose of 10mg for up to three days.
Method of administration:
Prednisolone 5 mg Tablets are best taken dissolved in water, but they can be swallowed whole without difficulty.
). Symptoms typically emerge within a few days or weeks of starting the treatment. 5 Interaction with other medicinal products and other forms of interaction), although dose levels do not allow prediction of the onset, type, severity or duration of reactions.
Most adverse reactions resolve after either dose reduction or withdrawal of the medicine, 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 a 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. Scleroderma renal crisis Caution is required in patients with systemic sclerosis because of an increased incidence of (possibly fatal) scleroderma renal crisis with hypertension and decreased urinary output observed with a daily dose of 15 mg or more prednisolone.
Blood pressure and renal function (s-creatinine) should therefore be routinely checked. When renal crisis is suspected, blood pressure should be carefully controlled. Excipients The Prednisolone tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
5 Interaction with other medicinal products and other forms of interaction Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
Thyrotoxic Periodic Paralysis (TPP) can occur in patients with hyperthyroidism and with prednisone-induced hypokalemia. TPP must be suspected in patients treated with prednisone presenting signs or symptoms of muscle weakness, especially in patients with hyperthyroidism.
If TPP is suspected, levels of blood potassium must be immediately monitored and adequately managed to ensure the restoration of normal levels of blood potassium. 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 HPA suppression, the dose of systemic corticosteroid 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 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, been stopped following prolonged therapy they may need to be temporarily reintroduced.
1. Systemic infections, unless specific anti-infective therapy is employed. Live virus immunisation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone, ephedrine and aminoglutethimide enhance the metabolism of corticosteroids and its therapeutic effects may be reduced. Mifepristone may reduce the effect of corticosteroids for 3-4 days.
Erythromycin and ketoconazole may inhibit the metabolism of some corticosteroids. Ciclosporin increases plasma concentration of prednisolone. The same effect is possible with ritonavir. Oestrogens and other oral contraceptives may potentiate the effects of glucocorticoids and dosage adjustments may be required if oral contraceptives are added to or withdrawn from a stable dosage regimen.
The desired effects of hypoglycaemic agents (including insulin), anti- hypertensives and diuretics are antagonised by corticosteroids. The growth promoting effect of somatotropin may be inhibited by the concomitant use of corticosteroids.
Steroids may reduce the effects of anticholinesterases in myasthenia gravis and cholecystographic x-ray media. The efficacy of coumarin anticoagulants and warfarin may be enhanced by concurrent corticosteroid therapy and close monitoring of the INR or prothrombin time is required to avoid spontaneous bleeding.
Concomitant use of aspirin and Non Steroidal Anti-Inflammatory Drugs (NSAIDs) with corticosteroids increases the risk of gastro-intestinal bleeding and ulceration. The renal clearance of salicylates is increased by corticosteroids and steroid withdrawal may result in salicylate intoxication.
The hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics, and carbenoxolone, are enhanced by corticosteroids. The risk of hypokalaemia is increased with theophylline and amphotericin. Corticosteroids should not be given concomitantly with amphotericin, unless required to control reactions.
The risk of hypokalaemia also increases if high doses of corticosteroids are given with high doses of bambuterol, fenoterol, formoterol, ritodrine, salbutamol, salmeterol and terbutaline. The toxicity of cardiac glycosides is increased if hypokalaemia occurs with corticosteroids.
Concomitant use with methotrexate may increase the risk of haematological toxicity. High doses of corticosteroids impair the immune response and so live vaccines should be avoided (see also warnings). 6 Fertility, pregnancy and lactation Pregnancy The ability of corticosteroids to cross the placenta varies between individual drugs, however, 88% of prednisolone is inactivated as it crosses the placenta.
Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate, intra-uterine growth retardation and effects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate/ lip in man.
However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra- uterine growth retardation. Hypoadrenalism may, in theory occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important.
As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential however, patients with normal pregnancies may be treated as though they were in the non-gravid state.
Patients with pre-eclampsia or fluid retention require close monitoring. Depression of hormone levels has been described in pregnancy, but the significance of this finding is not clear. Breast-feeding Corticosteroids are excreted in small amounts in breast milk.
However, doses of up to 40mg daily of prednisolone are unlikely to […]
• Patients receiving doses of systemic corticosteroid greater than 40 mg daily of prednisolone (or equivalent), • Patients repeatedly taking doses in the evening. 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.
Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. Withdrawal of corticosteroids after prolonged therapy must therefore always be gradual to avoid acute adrenal insufficiency, being tapered off over weeks or months according to the dose and duration of treatment.
During prolonged therapy any 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.
Suppression of the HPA axis and other 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 alternate days.
Frequent patient review is required to appropriately titrate the dose against disease activity. 2). Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Anti-inflammatory/immunosuppressive effects and infection Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission. g. in the setting of organ transplantation), has been associated with an increased risk of malignancy.
Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The resultant opportunistic infections may be fatal. 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.
Chickenpox is of particular concern since this normally minor illness may be fatal in immunosuppressed patients. Patients 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.
If the patient is a child parents must be given the above advice. 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 specialist care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased. Patients should be advised to take particular care to avoid exposure to measles and to seek immediate advice if exposure occurs.
Prophylaxis with intramuscular normal immunoglobulin may be needed. Live vaccines should not be given to individuals with impaired immune responsiveness caused by high doses of corticosteroids. The antibody response to other vaccines may be diminished.
Because of the possibility of fluid retention, care must be taken when corticosteroids are administered to patients with renal insufficiency or hypertension or congestive heart […]