Philcort-16 Dosage/Direction for Use

Dose: Because complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.
The lowest possible dose of corticosteroid should be used to control the condition under treatment and when reduction in dosage is possible, the reduction should be gradual.
The initial dosage of Methylprednisolone Tablets may vary from 4 mg to 48 mg of methylprednisolone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice, while in selected patients, higher initial doses may be required.
Do not halve the tablets.
Clinical situations in which high doses therapy may be indicated include cerebral edema (200-1000 mg/day), organ transplantation (up to 7 mg/kg/day), and multiple sclerosis. In treatment of acute exacerbations of multiple sclerosis, oral methylprednisolone regimens of 500 mg/day for 5 days or 1000 mg/day for 3 days have been shown to be effective (4 mg of methylprednisolone is equivalent to 5 mg of prednisolone). The initial dosage should be maintained or adjusted until a satisfactory response is noted. If, after a reasonable period of time, there is a lack of satisfactory clinical response, Methylprednisolone Tablets should be discontinued and the patient transferred to other appropriate therapy. If after long-term therapy the drug is to be stopped, it is recommended that it will be withdrawn gradually rather than abruptly.
It should be emphasised that dosage requirements are variable and must be individualised on the basis of the disease under treatment and the response of the patient. After a favourable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of Methylprednisolone Tablets for a period of time consistent with the patient's condition.
Alternate Day Therapy (ADT): Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticosteroid is administered every other morning. The purpose of this mode of therapy is to provide a patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimising certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms and growth suppression in children.
The rationale for this treatment schedule is based on two major premises: The anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-corticosteroid day.
The following should be kept in mind when considering alternate day therapy: Basic principles and indications for corticosteroid therapy should apply. The benefits of ADT should not encourage the indiscriminate use of corticosteroids.
ADT is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticosteroid therapy is anticipated.
In less severe disease processes in which corticosteroid therapy is indicated, it may be possible to initiate treatment with ADT. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible, particularly when subsequent use of alternate day therapy is intended.
Once control has been established, two courses are available: Change to ADT and then gradually reduce the amount of corticosteroid given every other day, or; Following control of the disease process reduce the daily dose of corticosteroid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course may be preferable.
Because of the advantages of ADT, it may be desirable to try patients on this form of therapy who have been on daily corticosteroid for long periods of time (e.g. patients with rheumatoid arthritis). Since these patients may already have suppressed HPA axis, establishing them on ADT may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administered this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum.
As indicated previously, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g. dexamethasone and betamethasone).
The maximal activity of the adrenal cortex is between 2:00 AM and 8:00 AM, and it is minimal between 4:00 PM and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am).
In using ADT it is important, as in all therapeutic situations, to individualise and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of ADT will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-corticosteroid day. Other symptomatic therapy may be added or increased at this time if needed.
In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticosteroid dose for control. Once control is again established alternate day therapy may be reinstituted.
Although many of the undesirable features of corticosteroid therapy can be minimised by ADT, as in any therapeutic situation, the physician must carefully weigh the benefit risk ratio for each patient in whom corticosteroid therapy is being considered.