DILACORT Gastro-resistant tablet Ref.[49968] Active ingredients: Prednisolone

Posology

The initial dosage of Dilacort gastro-resistant tablets may vary from 5mg to 60mg daily 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 (See Section 4.4).

In patients who have received more than physiological dose for systemic corticosteroids (approximately 7.5mg 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 hypothalamic-pituitary-adrenal (HPA) suppression, the dose of corticosteroid may be reduced rapidly to physiological doses. Once a daily dose equivalent to 7.5mg 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 40mg 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 40mg daily of prednisolone (or equivalent).
• patients repeatedly taking doses in the evening. (See Section 4.4)

During prolonged therapy, dosage may need to be temporarily increased during periods of stress or during exacerbations of the disease (See Section 4.4).

If there is lack of a satisfactory clinical response to Dilacort gastro-resistant tablets, the drug should be gradually discontinued and the patient transferred to alternative therapy.

Intermittent dosage regimen: A single dose of Dilacort gastro-resistant 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.

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 (See also Sections 4.4 and 4.8).

Paediatric population

Although appropriate fractions of the actual dose may be used, dosage will usually be determined by clinical response as in adults (see also Section 4.4). Alternate day dosage is preferable where possible.

Method of administration

Dilacort gastro-resistant tablets are for oral use only.

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.

36 months.

Store below 30°C.

PVC/PVdC/Aluminium blisters.

Pack size of 28 tablets.

No special requirements.