Active Ingredient: Methylprednisolone
Fulminating or disseminated tuberculosis (with appropriate anti-tuberculous chemotherapy).
The use of corticosteroids in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
4 - 48 mg
From 2 To 24 mg 2 time(s) per day every day
The dosage recommendations shown in the table below are suggested initial daily doses and are intended as guides. The average total daily dose recommended may be given either as a single dose or in divided doses (excepting in alternate day therapy when the minimum effective daily dose is doubled and given every other day at 8.00 am).
Undesirable effects may be minimised by using the lowest effective dose for the minimum period.
The initial suppressive dose level may vary depending on the condition being treated. This is continued until a satisfactory clinical response is obtained, a period usually of three to seven days in the case of rheumatic diseases (except for acute rheumatic carditis), allergic conditions affecting the skin or respiratory tract and ophthalmic diseases. If a satisfactory response is not obtained in seven days, re-evaluation of the case to confirm the original diagnosis should be made. As soon as a satisfactory clinical response is obtained, the daily dose should be reduced gradually, either to termination of treatment in the case of acute conditions (e.g. seasonal asthma, exfoliative dermatitis, acute ocular inflammations) or to the minimal effective maintenance dose level in the case of chronic conditions (e.g. rheumatoid arthritis, systemic lupus erythematosus, bronchial asthma, atopic dermatitis). In chronic conditions, and in rheumatoid arthritis especially, it is important that the reduction in dosage from initial to maintenance dose levels be accomplished as clinically appropriate. Decrements of not more than 2 mg at intervals of 7-10 days are suggested. In rheumatoid arthritis, maintenance steroid therapy should be at the lowest possible level.
In alternate-day therapy, the minimum daily corticoid requirement is doubled and administered as a single dose every other day at 8.00 am. Dosage requirements depend on the condition being treated and response of the patient.
Elderly patients: 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, particularly osteoporosis, diabetes, hypertension, susceptibility to infection and thinning of skin.
Paediatric population: In general, dosage for children should be based upon clinical response and is at the discretion of the physician. Treatment should be limited to the minimum dosage for the shortest period of time. If possible, treatment should be administered as a single dose on alternate days.
Intramuscular
10 - 30 mg per kg of body weight
From 2.5 To 7.5 mg per kg of body weight 4 time(s) per day every day
In the treatment of high dose indications, such as haematological, rheumatic, renal and dermatological conditions, a dosage of 30 mg/kg/day to a maximum of 1 g/day is recommended. This dosage may be repeated for three pulses either daily or on alternate days. In the treatment of graft rejection reactions following transplantation, a dosage of 10 to 20 mg/kg/day for up to 3 days, to a maximum of 1 g/day, is recommended.
Intravenous
10 - 30 mg per kg of body weight
From 2.5 To 7.5 mg per kg of body weight 4 time(s) per day every day
In the treatment of high dose indications, such as haematological, rheumatic, renal and dermatological conditions, a dosage of 30 mg/kg/day to a maximum of 1 g/day is recommended. This dosage may be repeated for three pulses either daily or on alternate days. In the treatment of graft rejection reactions following transplantation, a dosage of 10 to 20 mg/kg/day for up to 3 days, to a maximum of 1 g/day, is recommended.
When administering methylprednisolone in high doses intravenously it should be given over a period of at least 30 minutes. Doses up to 250 mg should be given intravenously over a period of at least five minutes.
For intravenous infusion the initially prepared solution may be diluted with 5% dextrose in water, isotonic saline solution, or 5% dextrose in isotonic saline solution. To avoid compatibility problems with other drugs methylprednisolone should be administered separately, only in the solutions mentioned.
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