(1997; 132 pages) [French] [Spanish]
Tablet, 5 mg
Powder for injection, 10 mg, 25 mg (as sodium phosphate or sodium succinate) in vial
Prednisolone is a synthetic glucocorticoid with weak mineralocorticoid properties. Its therapeutic effects result from inhibition of macrophage accumulation, suppression of capillary wall permeability, and reduction of fibroblast proliferation and collagen deposition. It is readily absorbed from the gastrointestinal tract, is extensively protein-bound and has a plasma half-life of about 8 hours.
• bullous pemphigoid and pemphigus
• exfoliative dermatitis
• severe atopic and contact dermatitis
• severe lichen planus.
Dosage and administration
All doses are suitable for adults and children. The lowest dosage to produce an acceptable clinical response should be used. The dosage depends on the disease, its severity and the response to treatment. A single daily dose given early in the morning may reduce the magnitude of the side-effects.
Bullous pemphigoid and pemphigus:
Treatment should start at an initial dose of 1-2 mg/kg daily. The dosage should be raised progressively to 5 mg/ kg if a prompt response is not obtained. Once stabilization has occurred, the dosage should be gradually reduced to the lowest dosage that maintains remission.
Exfoliative dermatitis, severe lichen planus, and severe atopic and contact dermatitis:
A dosage of 10-30 mg daily is usually sufficient. In contact dermatitis, oral prednisolone can be given in successively lower doses over a 2-week period.
During prolonged therapy, the dosage may need to be increased temporarily during periods of stress or acute exacerbations of the disease.
Withdrawal of treatment must be gradual to avoid adrenal insufficiency. After prolonged treatment, decrements of as little as 1 mg monthly may be necessary.
• Known hypersensitivity to corticosteroids.
• Prednisolone should not be used, except in life-threatening situations, in patients with active bacterial, viral or fungal infections.
Patients must understand the importance of following dosage instructions rigorously.
Patients on long-term treatment must remain under close medical supervision. Body weight, blood pressure, fluid and electrolyte balance and blood glucose concentrations should be monitored throughout treatment. Bone pain, and particularly backache, may be indicative of osteoporosis.
The response of the pituitary-adrenal axis to stress is reduced and may remain depressed for many months after withdrawal of the drug. If an infection occurs during this period, prednisolone therapy may need to be reinstituted temporarily.
Should a patient receiving, or having recently received, long-term prednisolone therapy require emergency surgery, parenteral hydrocortisone should be administered as follows:
• 200 mg i.m. with premedication;
• 100 mg infused i.v. in 500 ml of saline during the procedure;
• 100 mg i.m. every 6 hours for 72 hours.
For minor surgical procedures, 100 mg of hydrocortisone should be administered i.m. shortly before and after the intervention.
Systemic corticosteroid preparations should be used only for serious conditions in patients with diabetes, tuberculosis, peptic ulcer, hypertension, glaucoma, epilepsy, a history of mental disorder or psoriasis. Patients with a history of tuberculosis should receive prophylactic chemotherapy during prolonged therapy.
Children on corticosteroid therapy should receive a course of γ-globulin if they are exposed to a childhood viral infection to which they have no acquired immunity. They should not receive live-virus vaccines. Intermittent dosage regimens should be used in children when therapy is prolonged for more than 6 months, to reduce the risk of stunted growth.
Use in pregnancy
Systemic corticosteroid preparations should not be administered during pregnancy unless the need of the mother outweighs any possible risk of harm to the fetus. Adrenal development may be impaired and an association with cleft palate and other fetal abnormalities has been described, particularly in the case of fluorinated compounds. Dosage should be kept as low as possible.
Adverse effects are dependent on the dosage and duration of treatment.
Doses in excess of 20 mg daily are immunosuppressive. Infections contracted during therapy can be fatal in the absence of effective treatment. Quiescent tuberculosis may be reactivated.
Long-term treatment at dosages in excess of normal physiological requirements (approximately 10 mg daily) is liable to result in:
• stunting of growth in children, which may be averted by giving corticotrophin and selecting alternate-day dosage schedules;
• features of hypercorticalism, including moon face, acne, bruising, abdominal striae, trunkal obesity, muscle wasting, hypertension and amenorrhoea and hirsutism in females;
• spinal osteoporosis and vertebral collapse, which may be retarded by giving calcium supplements and small doses of vitamin D;
• aseptic osteonecrosis, particularly of the femoral head;
• subcapsular cataracts and glaucoma;
• development or aggravation of peptic ulcers;
• diabetes mellitus;
• depression and psychosis, with risk of suicide;
• raised intracranial pressure and convulsions, particularly in children;
• increased coagulability of blood;
• delayed tissue healing;
• myopathy, characterized by weakness of the proximal musculature of arms and legs.
Psoriasis may be seriously exacerbated on sudden withdrawal of systemic corticosteroid therapy.
Hepatic enzyme inducers including phenobarbitone, phenytoin and rifampicin may accelerate the metabolism of prednisolone.
The response to oral anticoagulants may be altered. Inhibition is characteristic, but isolated cases of potentiation have been reported.
Concomitant administration of acetylsalicylic acid or nonsteroidal anti-inflammatory drugs may increase the incidence of gastrointestinal ulceration.
Concomitant administration of diuretics that inhibit the reabsorption of potassium increases the risk of hypokalaemia.
A single large overdose is unlikely to result in dangerous sequelae.
Symptomatic treatment is essential in the management of adverse effects resulting from long-term therapy.
Tablets should be stored in well-closed containers. Vials should be protected from light and should not be allowed to freeze.