(and dosage form):
Each tablet contains 5 mg Prednisolone.
A 21.5.1 Corticosteroids and analogues.
Prednisolone is a synthetic glucocorticoid.
Prednisolone has five times the potency of cortisone acetate but in equivalent doses causes less sodium and fluid retention although more gastric symptoms.
Prednisolone is readily absorbed from the gastro-intestinal tract.
Peak plasma concentrations of prednisolone are obtained 1 or 2 hours after administration by mouth, and it usually has a plasma half-life of 2 or 3 hours. Prednisolone is extensively bound to plasma proteins.
Prednisolone is excreted in the urine as free and conjugated metabolites, together with an appreciable amount of unchanged prednisolone.
Prednisolone crosses the placenta and small amounts are excreted in breast milk.
Prednisolone is indicated in all conditions where corticosteroid therapy is likely to be of benefit. These include acute haemolytic disorders, allergic disorders, asthma, leukaemia, thrombocytopenic purpura, coeliac disease, insulin resistance in diabetes mellitus, immunosuppression, liver disorders and ulcerative colitis.
Patients with peptic ulcer, osteoporosis, psychoses, or severe psychoneuroses. It should be used with great caution in the presence of congestive heart failure, hypertension, diabetes mellitus, infectious diseases, chronic renal failure, uraemia and in elderly persons. Patients with active tuberculosis or doubtfully quiescent tuberculosis should not given prednisolone. Prednisolone is contraindicated in the presence of acute infections, including Herpes zoster and Herpes simplex ulceration of the eye. Vaccination with live vaccine is contra-indicated, but killed vaccines or toxoids may be given.
Sudden withdrawal or reduction in dosage, or an increase in corticosteroid requirements associated with the stress of infection, or accidental or surgical trauma may cause acute adrenal insufficiency. Symptoms of adrenal insufficiency include malaise, muscle weakness, mental changes, muscle and joint pain, desquamation of the skin, dyspnoea, anorexia, nausea and vomiting, fever, hypoglycaemia, hypotension and dehydration.
DOSAGE AND DIRECTIONS FOR USE:
The usual dose is up to 60 mg daily in divided doses.
Prednisolone withdrawal should always be gradual. The rate depends on the patients response, the dose and duration of therapy. Adrenal function should be monitored throughout withdrawal and symptoms attributable to overrapid withdrawal should be countered by resuming a higher dose and continuing the reduction at a slower rate.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Prednisolone may cause sodium retention, electrolyte imbalance and oedema.
The insulin requirements of diabetic patients is increased. Increased appetite is often reported.
Other excessive metabolic effects lead to mobilisation of calcium and phosphorus, with osteoporosis and spontaneous fractures, nitrogen depletion, and hyperglycaemia with accentuation or precipitation of the diabetic state.
The effect on tissue repair is evident by delayed wound healing and increased likelihood of infection. Increased susceptibility to all kinds of infection, including sepsis, fungus infections and viral infections, has been reported in patients on prednisolone therapy.
Growth retardation in children has been reported.
Large doses of prednisolone may produce symptoms characteristic of hyperactivity of the adrenal cortex, with moon-face, hirsutism, ecchymosis, myopathy, psychoses, buffalo hump, flushing, increased bruising, striae and acne, sometimes leading to a fully developed Cushing's syndrome.
Other adverse effects include amenorrhoea, hyperhidrosis, mental and neurological disturbances, intracranial hypertension, acute pancreatitis, and aseptic necrosis of bone. An increase in blood coagulability may lead to thromboembolic complications.
It should be used with great caution in the presence of congestive heart failure, in patients with diabetes mellitus, infectious diseases, chronic renal failure, uraemia and in elderly patients.
Infections may be masked due to marked anti-inflammatory properties with analgesic and antipyretic effects, and may produce a feeling of well-being.
Administration of prednisolone may also cause a reduction in the number of circulating lymphocytes.
Muscular weakness is a side-effect, particularly when prednisolone is taken in large doses.
The incidence of side-effects rises steeply if dosage increases much above 7,5 mg daily. Short courses at high dosage for emergencies appear to cause less side-effects than prolonged courses with lower doses.
Concurrent administration of barbiturates, phenytoin, or rifampicin may enhance the metabolism and reduce the effects of prednisolone.
Response to anticoagulants may be reduced and, on some occasions, enhanced by corticosteroids.
Concurrent administration of prednisolone, and the potassium-depleting diuretics may cause excessive potassium loss. Protein metabolism may be effected possibly resulting in a negative nitrogen balance.
Dyspepsia is a common side-effect with prednisolone therapy and gastric ulceration could occur.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions".
Treatment is symptomatic and supportive, and where possible the dosage should be reduced or the drug slowly withdrawn.
White, biconvex, bisected tablet.
Containers of 100, 500, 1 000 and 5 000.
Protect from light.
Store below 25°C in airtight containers.
KEEP OUT OF REACH OF CHILDREN.
G2968 (Act 101/1965).
NAME AND BUSINESS ADDRESS OF APPLICANT:
7 Fairclough Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
Updated on this site: December 2002
Source: Community Pharmacy
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