Loading…
PREDNISOLONE is a brand name for Prednisolone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Systemic Autoimmune Diseases Systemic lupus erythematosus, Acute rheumatic fever Haematological Disorders Acute granulocytic leukaemia, Acute monocytic leukaemia, Chronic lymphocytic leukaemia, Thrombocytopenia, Haemolytic anaemia. Miscellaneous Ulcerative colitis Pemphigus Non-inflammatory nephropathy.
Verbatim from this product's MHRA label. Tap a section to expand.
Route of Administration:
Oral Adults: In the initial treatment of acute illnesses such as described under 'Therapeutic Indications', daily doses of 75mg or more may be needed. The daily dose should be taken in the morning after breakfast. In alternate day therapy, the average daily dose is doubled and given every other day in the morning after breakfast.
The lowest dose to produce an acceptable result should be given; when it is possible to reduce the dose, this should be undertaken gradually in stages. Following prolonged treatment with prednisolone, the dose may need to be increased temporarily during periods of stress or exacerbation of illness.
The dose will depend on the disease, its severity and the clinical response. For further information with reference to dosage see 'Special Warnings and Special Precautions for Use'. Paediatric population Children Although appropriate fractions of the adult dose may be used, dosage will usually be determined by clinical response as in adults.
Note:
As these are 25 mg tablets, the use of lower dosage formulations in children is generally preferred. Children:Aged 1-6 years - One quarter the adult dose. Aged 7-11 years - One half the adult dose. Aged 12-17 years - Three quarters the adult dose.
Corticosteroids cause growth retardation in infancy, childhood and adolescence which may be irreversible. Treatment should be limited to the minimum dosage for the shortest possible time. In order to minimise suppression of the hypothalamo-pituitary adrenal axis and growth retardation, treatment should be administered where possible as a single dose on alternate days.
The incidence of predictable undesirable effects including hypothalamic- pituitary-adrenal suppression correlates with the relative potency of the drug, dosage, timing of administration and duration of treatment. ) - Endocrine and metabolic: suspension of growth in infancy, childhood and adolescence, menstrual irregularities, amenorrhoea, cushingoid facies, hirsutism and weight gain, decreased carbohydrate tolerance with development of classical symptoms of diabetes mellitus, increased need for insulin or oral hypoglycaemic agents in diabetes, negative nitrogen balance due to protein catabolism and negative calcium balance.
- Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. - The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculous may be masked and may reach an advanced stage before being recognised.
- Gastro-intestinal: peptic ulceration with perforation and haemorrhage. Fatalities have been reported: perforation of the small and large bowel, particularly in patients with inflammatory bowel disease; other gastro-intestinal side effects include dyspepsia, abdominal distension, oesophageal ulceration and candidiasis, acute pancreatitis.
- Musculo-skeletal: muscle weakness, proximal myopathy, wasting and loss of muscle mass, osteoporosis, vertebral compression fractures, avascular necrosis of bone, pathological fractures of long bones and rupture of tendons. 5). - Fluid and electrolyte disturbance: sodium and water retention leading to congestive heart failure in susceptible subjects, hypertension, potassium loss and hypokalaemic alkalosis.
- Dermatological: impaired wound healing, skin atrophy, petechial haemorrhage and ecchymoses, erythema, telangiectasia, skin striae and acne. - Neuropsychiatric: Potentially severe Psychiatric reactions: - 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.
1. A patient information leaflet should be supplied with this product. 2. 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 temporary increase in dosage; if corticosteroids have been stopped following prolonged therapy they may need to be temporarily re- introduced.
3. 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.
Frequent patient review is required to appropriately titrate the dose against disease activity. 4. Care and frequent patient monitoring is necessary in patients with the following complaints: diabetes mellitus (or a family history of diabetes), osteoporosis (post-menopausal women are particularly at risk), hypertension, congestive heart failure, patients with a history of severe or pre-existing affective disorders (especially a history of steroid psychosis), glaucoma or a family history of glaucoma, previous corticosteroid induces myopathy, epilepsy, liver failure, renal insufficiency or peptic ulceration.
5. Suppression of the inflammatory response and immune function increases the susceptibility to 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 advanced stage before being recognised.
6. Chicken pox 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 chicken pox should be advised to avoid close personal contact with chickenpox or herpes zoster and if exposed they should seek urgent medical attention.
Systemic fungal and viral infections: acute bacterial infections unless specific anti- infective therapy is given. Hypersensitivity to any ingredient.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Prednisolone in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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.
Other psychiatric reactions: - There is increased risk of raised intracranial pressure and papilloedema in children (pseudotumour cerebri) usually after treatment withdrawal. Aggravation of epilepsy. Psychological dependence may be marked.
- Opthalmic: increased intra-ocular pressure with development of glaucoma, papilloedema, posterior subcapsular cataracts, corneal and scleral thinning or perforation after prolonged use. Viral or fungal ophthalmic disease may be reignited or spread.
- Miscellaneous: opportunistic infections occur more frequently in corticosteroid recipients; hypersensitivity including anaphylaxis, thromboembolism and increased appetite has also been reported. Clinical reactivation of previously dormant tuberculosis, leukcytosis (sometimes an almost leukaemoid-like reaction) may occur.
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.
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. 7. Corticosteroids should be given with care in patients with a history of tuberculosis or the characteristic appearance of tuberculosis disease on X-Ray.
The emergence of tuberculosis can however, be prevented by the prophylactic use of anti-tuberculosis therapy. 8. Live virus vaccines should not be administered to patients with impaired immune-responsiveness. If in activated vaccines are administered to such individuals, the expected serum antibody response may not be obtained.
9. Patients should carry 'steroid treatment' cards which give a clear guidance on the precautions to be taken to minimise risk and which provide details of prescriber, drug, dosage and the duration of treatment. 10. Withdrawal symptoms and signs: too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death.
A 'withdrawal syndrome' may also occur including fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight. 11. Use in children: corticosteroids cause dose-related growth retardation in infancy, childhood and adolescence which may be irreversible 12.
Use in elderly: the common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age, especially osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning of the skin.
Close clinical supervision is required to avoid life threatening reactions. 13. 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 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 maniac-depressive illness and previous steroid psychosis. 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 on withdrawal of systemic corticosteroids but there is uncertainty about HPA suppression, the dose of systemic corticosteroid may be reduced rapidly to physiological doses.
5mg of prednisolone is reached, dose reduction should be slower to allow HPA-axis to recover. Abrupt withdrawal of systemic […]