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Analgesics & Antipyretics

Predstad


Pack size:

Box of 2 blisters x 10 water-dispersible tablets.

 

Composition:

Each water-dispersible tablet contains prednisolone 20 mg 

(As prednisolone sodium metasulfobenzoate 31.44 mg).

 

Shelf-life:

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • For the treatment and/or suppression of inflammatory and allergic disorders.
     
  • Administered orally by dispersing the tablet in a little water. The daily dose should be taken in the morning after breakfast.
     
  • In adults and the elderly: The lowest effective dose should be used for the minimum period in order to minimise side effects.
  • In children: Prednisolone should be used only when specifically indicated, in a minimum dosage and for the shortest possible time.
     
  • The initial dosage of prednisolone may vary from 5 mg to 60 mg or more depending on the disorder being treated. Divided daily dosage is usually used.
  • The following therapeutic guidelines should be kept in mind for all therapy with corticosteroids: 
    - Corticosteroids are palliative symptomatic treatment by virtue of their anti-inflammatory effects; they are never curative.
    - The appropriate individual dose must be determined by trial and error and must be re-evaluated regularly according to activity of the disease.
    - As corticosteroid therapy becomes prolonged and as the dose is increased, the incidence of disabling side-effects increases. 
    - In general, initial dosage shall be maintained or adjusted until the anticipated response is observed. The dose should be gradually reduced until the lowest dose which will maintain an adequate clinical response is reached. Use of the lowest effective dose may also minimise side-effects.
  • During prolonged therapy, dosage may need to be temporarily increased during periods of stress or during exacerbations of the disease.
  • If there is lack of a satisfactory clinical response to Predstad, the drug should be gradually discontinued and the patient transferred to alternative therapy. 
     
  • Intermittent dosage regimen: A single dose of Predstad 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. Dosage reductions should not exceed 5 - 7.5 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. 
  • Use in children: Although appropriate fractions of the actual dose may be used, dosage will usually be determined by clinical response as in adults. Alternate day dosage is preferable where possible.
  • Use in elderly: Treatment of elderly patients, particularly if long-term, should be planned bearing in mind the more serious consequences of the common side-effects of corticosteroids in old age.


Or as prescribed by physicians.

 

  • Known hypersensitivity to any ingredient of the drug.
  • Serious infection, except septic shock or tuberculous meningitis.
  • Viral, fungal, or tubercular skin infection.
  • Administration of live virus vaccines.

     

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. 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.

The incidence of predictable undesirable effects, including hypothalamic-pituitary adrenal suppression correlates with the relative potency of the drug, dosage, timing of administration and the duration of treatment.

Common

  • Irritability, depressed and labile mood, suicidal thoughts, psychotic reactions, mania, delusions, hallucinations, and aggravation of  schizophrenia. Behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia.

Very rare

  •  Calciphylaxis.

Not known (cannot be estimated from the available data)

  • Increases susceptibility to, and severity of infections (with suppression of clinical symptoms and signs), opportunistic infections, recurrence of dormant tuberculosis, oesophageal candidiasis.
  • Leucocytosis.
  • Hypersensitivity including anaphylaxis.
  • Suppression of the hypothalamo-pituitary adrenal axis (particularly in times of stress, as in trauma, surgery or illness), cushingoid facies, impaired carbohydrate tolerance with increased requirement for antidiabetic therapy, manifestation of latent diabetes mellitus.
  • Sodium and water retention, hypokalaemic alkalosis, potassium loss, negative nitrogen and calcium balance, glucose intolerance and protein catabolism. Increase both high and low density lipoprotein cholesterol concentration in the blood. Increased appetite (which may result in weight gain). Weight gain, obesity, hyperglycaemia, dyslipidaemia.
  • Euphoria, psychological dependence, depression.
  • Depression, insomnia, dizziness, headache, vertigo. Raised intracranial pressure with papilloedema (pseudotumor cerebri) (usually after treatment withdrawal). Aggravation of epilepsy, epidural lipomatosis. vertebrobasilar stroke (exacerbation of giant cell arteritis, with clinical signs of evolving stroke has been attributed to prednisolone).
  • Glaucoma, papilloedema, posterior subcapsular cataracts, nuclear cataracts (particularly in children), exophthalmos, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal disease.
    Severe exacerbation of bullous exudative retinal detachment; central serous chorioretinopathy or lasting visual loss in some patients with idiopathic central serous chorioretinopathy.
  • Vertigo.
  • Congestive heart failure in susceptible patients, hypertension, increased risk of heart failure. Increased risk of cardiovascular disease, including myocardial infarction (with high dose therapy). 
  • Thromboembolism.
  • Dyspepsia, nausea, peptic ulceration with perforation and haemorrhage, abdominal distension, abdominal pain, diarrhoea, oesophageal ulceration, acute pancreatitis.
  • Hirsutism, skin atrophy, bruising, striae, telangiectasia, acne, increased sweating, pruritis, rash, urticaria.

  • Proximal myopathy, osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture, tendinopathies (particularly of the Achilles and patellar tendons), myalgia, growth suppression in infancy, childhood and adolescence.

  • Menstrual irregularity, amenorrhoea.

  • Fatigue, malaise, impaired healing.

  • Increased intra-ocular pressure, may suppress reactions to skin tests.

    Withdrawal symptoms: Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death. A steroid "withdrawal syndrome" seemingly unrelated to adrenocortical insufficiency may also occur following abrupt discontinuance of glucocorticoids. This syndrome includes symptoms such as: anorexia, nausea, vomiting, lethargy, headache, fever, desquamation, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules weight loss, and/or hypotension. These effects are thought to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid levels. Psychological effects have been reported on withdrawal of corticosteroids.

     

Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids. Symptoms typically emerge within a few days or weeks of starting the treatment. Risks may be higher with high doses/systemic exposure, 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 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 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.

Caution is necessary when corticosteroids, including prednisolone, are prescribed to patients with the following conditions and frequent patient monitoring is necessary:

  • Diabetes mellitus or in those with a family history of diabetes.
  • Glaucoma or in those with a family history of glaucoma.
  • Hypertension or congestive heart failure.
  • Liver failure.
  • Epilepsy.
  • Osteoporosis: This is of special importance in post-menopausal females who are at particular risk.
  • Patients with a history of severe affective disorders and particularly those with a previous history of corticosteroid induced psychoses.
  • Peptic ulceration.
  • Previous steroid myopathy.
  • Glucocorticoids should be used cautiously in patients with myasthenia gravis receiving anticholinesterase therapy.
  • Because cortisone has been reported rarely to increase blood coagulability and to precipitate intravascular thrombosis, thromboembolism, and thrombophlebitis, corticosteroids should be used with caution in patients with thromboembolic disorders.
  • Renal insufficiency.
  • Tuberculosis: Those with a history of, or X-ray changes characteristic of tuberculosis. The emergence of active tuberculosis can, however, be prevented by the prophylactic use of antituberculous therapy.
  • Recent myocardial infarction (rupture).
  • Chickenpox: Chickenpox 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 chickenpox 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 special care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased.
  • Measles: Patients are advised to avoid exposure to measles, medical advice should be sought if exposure occurs. Propylaxis with intramuscular normal immunoglobulin may be needed.
  • 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.
  • The effect of corticosteroids may be enhanced in patients with hypothyroidism in those with chronic liver disease with impaired hepatic function.
  • Live vaccines should not be given to individuals with impaired immune responsiveness. The antibody response to other vaccines may be diminished.
  • Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment.

Withdrawal

In patients who have received more than physiological doses of systemic corticosteroids (approximately 7.5 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. Once a daily dose equivalent to 7.5 mg of 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,
  • Patients receiving doses of systemic corticosteroid greater than 40 mg daily of prednisolone,
  • Patients repeatedly taking doses in the evening.

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 reintroduced.

Use in children

Corticosteroids cause growth retardation in infancy, childhood and adolescence, which may be irreversible and therefore long-term administration of pharmacological doses should be avoided. If prolonged therapy is necessary, treatment should be limited to the minimum suppression of the hypothalamo-pituitary adrenal axis and growth retardation. The growth and development of infants and children should be closely monitored. Treatment should be administered where possible as a single dose on alternate days.

Use in the elderly

Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious consequences of the common side-effects of corticosteroids in old age, especially osteoporosis, diabetes, hypertension, hypokalaemia, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life threatening reactions.

Instructions about how to manage adverse reactions (ADR)

After long-term treatment, suppression of the HPA axis is possible, it is imperative that the dose of glucocorticoid is reduced gradually, i.e. step-wise, rather than withdrawn abruptly. One suggested protocol for tapering is to decrease the dosage by the equivalent of 2.5 to 5 mg of prednisolone every 3 to 7 days until the physiological dose of approximately 5 mg of prednisolone is reached. If the patient's condition worsens during withdrawn, increase the dose and resume tapering more gradually.

Use the treatment regimen that avoids continuous exposure to pharmacological doses. A single daily dose produces fewer adverse effects than divided doses, and alternate-day therapy is better still for minimizing adrenal suppression and other adverse effects. In alternate-day therapy, a single dose is administered every other day, and is given in the morning.

Prophylaxis for gastric and duodenal ulcerations using H2-histamine receptor antagonists or proton pump inhibitors is recommended when using high-dose systemic corticosteroids.

All patients on long-term therapy should have associated administration with calcitonin, calcitriol and supplement of their calcium intake to prevent osteoporosis. 

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, intrauterine 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 intrauterine 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.

Lactation

Corticosteroids are excreted in small amounts in breast milk. However doses of up to 40 mg daily of prednisolone are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression but the benefits of breast feeding are likely to outweigh any theoretical risk.

Effects on ability to drive and use machines

None known.

 

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