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PRECORTISYL FORTE is a brand name for Prednisolone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Collagen Diseases:- Systemic Lupus Erythematous, Acute Rheumatic Fever Haematological Disorders:- Acute granulocytic Leukaemia, Acute Monocytic Leukaemia, Chronic Lymphocytic Leukaemia, Thromcytopenia, Haemolytic Anaemia. Miscellaneous:- Ulcerative Colitis Pemphigus Nephrosis
Verbatim from this product's MHRA label. Tap a section to expand.
Route of Administration:
Oral. 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.
For further information with reference to dosage see ‘Special Warnings and Special Precautions for Use’.
4). Blood and metabolic disorders • Leukcytosis (sometimes an almost leukaemoid-like reaction) may occur. • Thromboembolism • Hypertension Endocrine and metabolic disorders • Suspension of growth in infancy, childhood and adolescence, • Menstrual irregularities, amenorrhoea, • Cushingoid facies, • Hirsutism and weight gain, increased appetite, • 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.
• Pheochromocytoma crisis. • Potassium loss and hypokalaemic alkalosis. • Fluid and electrolyte disturbance: sodium and water retention leading to congestive heart failure in susceptible subjects, Immune system disorders • Hypersensitivity including anaphylaxis • 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 disorders • Peptic ulceration with perforation and haemorrhage.
Fatalities have been reported: perforation of the small and large bowel, particularly in patients with inflammatory bowel disease; dyspepsia, • Abdominal distension • Oesophageal ulceration • Candidiasis • Acute pancreatitis Musculoskeletal and connective tissue disorders • Muscle weakness, • Proximal myopathy, • wasting and loss of muscle mass, • Osteoporosis, • Avascular necrosis of bone, • Pathological fractures of long bones and rupture of tendons.
5). • Vertebral fractures and fractures of the long bones (frequency not known) Skin and subcutaneous tissue disorders • Hypertrichosis, • Purpura, • Impaired wound healing, • Skin atrophy, • Petechial haemorrhage and ecchymoses, • Erythema, • Telangiectasia, • Skin striae • Acne Psychiatric disorders a) Potentially severe Psychiatric reactions: A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, restlessness, 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.
A patient information leaflet should be supplied with this product. 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.
Care and frequent patient monitoring is necessary in patients with the following: • diabetes mellitus (or a family history of diabetes), • osteoporosis (post-menopausal women are particularly at risk), • hypertension, • congestive heart failure, • myasthenia gravis, myopathy, muscle mass wasting and loss • patients with a history of severe or pre-existing affective disorders (especially a history of steroid psychosis), • glaucoma or a family history of glaucoma, • epilepsy • liver failure • renal insufficiency • peptic ulceration • Non-specific ulcerative colitis Infections 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. 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. 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. Tuberculosis Corticosteroids should be given with care in patients with a history of tuberculosis or the characteristic appearance of tuberculosis disease on X-Ray.
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.
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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.
b) 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.
4) • Corneal and scleral thinning or perforation after prolonged use. • Viral or fungal ophthalmic disease may be reignited or spread. • Chorioretinopathy. Cardiac disorders Hypertrophic cardiomyopathy in preterm infants. 4). 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%). Infections and infestations Opportunistic infections occur more frequently in corticosteroid recipients Clinical reactivation of previously dormant tuberculosis, 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.
The emergence of tuberculosis can however, be prevented by the prophylactic use of anti-tuberculosis therapy. 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.
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.
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.
8). Symptoms typically emerge within a few days or weeks of starting the treatment. 5) 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.
Visual disturbances 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.
Pheochromocytoma crisis, Pheochromocytoma crisis, which can be fatal, has been reported after administration of corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation.
8). Hypertrophic cardiomyopathy Has been reported after systemic administration of glucocorticosteroids in preterm infants. In infants receiving administration of systemic glucocorticosteroids, echocardiograms should be performed to monitor myocardial structure and function.
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 […]