PREDNISOLONE Tablet Ref.[7045] Active ingredients: Prednisolone

Posology

Adults and the elderly

The lowest effective dose should be used for the minimum period.

Children

Prednisolone should only be used when specifically indicated, at the lowest dose possible and for the shortest possible time.

The initial dosage of Prednisolone may vary from 5mg to 60mg daily depending on the disorder being treated. Divided daily dosage may be used. Administration as a once daily dose in the morning or on alternate days can reduce the risk of adrenocortical suppression (see Section 4.4 Special warnings and precautions for use). In some patients this may not be possible e.g. patients with rheumatoid arthritis with pronounced morning stiffness where an evening dose may need to be given.

The following therapeutic guidelines should be kept in mind for all therapy with corticosteroids:

The lowest dose to produce an acceptable result should be given. Initial dosage should be adjusted until the desired clinical response has been achieved. The dose should be gradually reduced until the lowest dose which will maintain an adequate clinical response is reached. As a guide, the daily dose should be reduced by 2.5–5 mg every second to fifth day (more rapidly at the higher initial dose levels) until the lowest possible maintenance dose is reached. Preferably this should not exceed 10 mg per day. Use of the lowest effective dose will tend to minimise side-effects. The incidence of side-effects increases with dose and duration of treatment (see Section 4.4 ‘Special warnings and special precautions for use’).

Particular care should be exercised in patients who have received higher than 7.5mg prednisolone daily or equivalent for more than 3 weeks, owing to a greater risk of suppression of the hypothalamic-pituitary-adrenal (HPA) axis in these patients. The speed with which dose can be reduced is also dependent on risk of relapse of the disease being treated. After prolonged treatment, tapering of dose below 7.5 mg (regarded as “equivalent” to physiological levels of glucocorticoids) should be conducted particularly cautiously.

More rapid withdrawal of systemic corticosteroid treatment that has been given for less than 3 weeks is appropriate if it is considered that the disease is unlikely to relapse. Withdrawal of doses of up to 40mg daily of prednisolone, or equivalent that have been administered for less than 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 40mg daily of prednisolone (or equivalent).
• Patients repeatedly taking doses in the evening.

(See Section 4.4 ‘Special warnings and special precautions for use’ and Section 4.8 ‘Undesirable effects’)

During prolonged therapy, dosage may need to be temporarily increased during periods of stress or during exacerbations of the disease (see Section 4.4 ‘Special warnings and special precautions for use’).

If there is lack of a satisfactory clinical response to Prednisolone Tablets, the drug should be gradually discontinued and the patient transferred to alternative therapy.

Intermittent dosage regimen: A single dose of Prednisolone Tablets 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 5-7.5mg daily during chronic treatment.

Allergic and skin disorders: Initial doses of 5-15mg daily are commonly adequate.

Collagenosis: Initial doses of 20-30mg daily are frequently effective. Those with more severe symptoms may require higher doses.

Rheumatoid arthritis: The usual initial dose is 10-15mg daily. The lowest daily maintenance dose compatible with tolerable symptomatic relief is recommended.

Blood disorders and lymphoma: An initial daily dose of 15-60mg is often necessary with reduction after an adequate clinical or haematological response. Higher doses may be necessary to induce remission in acute leukaemia.

Special populations

Use in elderly

Treatment of elderly patients, particularly if long-term, should be undertaken with caution bearing in mind the more serious consequences of the common side-effects of corticosteroids in old age (see also ‘Special warnings and special precautions for use’).

Use in children

Although appropriate fractions of the adult dose may be used, dosage will usually be determined by clinical response as in adults (see also Section 4.4 ‘Special warnings and special precautions for use’ and Section 4.8 ‘Undesirable effects’). Alternate day dosage is preferable where possible.

Method of administration

Prednisolone tablets should be taken following a meal to reduce the risk of gastric irritation.

Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. No specific antidote is available; treatment is supportive and symptomatic. Serum electrolytes should be monitored.

High systemic doses of corticosteroids caused by chronic use have been associated with adverse effects such as neuropsychiatric disorders (psychosis, depression, hallucinations), cardiac dysrhythmias and Cushing’s syndrome.

24 months.

Keep the blister packs in the outer carton in order to protect from light.

Blisters of AL/PVC containing packs of 28 tablets.

Not all pack sizes may be marketed.

Not available.