Medison Tablet 4mg (Methylprednisolone)

Adult use

1. The initial dose may vary from 4mg to 48mg per day as methylprednisolone, depending on the symptoms of the specific disease. In general, a low dose is sufficient for less severe conditions, although a high initial dose may be required in certain patients. The initial dose should be maintained or adjusted until a satisfactory response is achieved. If satisfactory clinical results are not obtained after a reasonable period, discontinue administration and switch to another appropriate treatment. The dose should be determined individually according to the various diseases being treated and the patient's response. After an adequate response is achieved, the appropriate maintenance dose should be determined by reducing the initial dose at suitable intervals until the lowest dose that maintains an adequate clinical response is reached. Continuous monitoring of the dose is required. Situations that may require dose adjustment include remission or worsening of the disease, individual patient responsiveness to the medication, and the effect on the patient of exposure to stressful circumstances that are not directly related to the symptoms of the disease being treated. In the latter case, it may be necessary to increase the dose for as long as needed to achieve a satisfactory effect on the patient's condition. After long-term treatment, gradual dose reduction is recommended when discontinuing the medication. 2. Multiple sclerosis For treatment of acute exacerbations of multiple sclerosis, administration of prednisolone 200mg daily for 1 week, followed by prednisolone 80mg every other day for 1 month, is effective (methylprednisolone 4mg is equivalent to prednisolone 5mg). 3. ADT (Alternate Day Therapy) Alternate day therapy is a regimen in which twice the daily dose is administered on one morning every 2 days. The purpose of this regimen is to enhance the effects of corticosteroids in patients who require long-term medication and to minimize adverse effects such as pituitary-adrenal suppression, Cushingoid state, corticosteroid withdrawal symptoms, and growth suppression in children. The rationale for this treatment plan is based on the following 2 important premises: 1) The anti-inflammatory and therapeutic effects of corticosteroids persist longer than their physical presence and metabolic effects; and 2) Taking corticosteroids in the morning every other day restores nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the days corticosteroids are not administered. A brief summary of HPA physiology may help explain this rationale. Free cortisol acts primarily through the hypothalamus; therefore, a decrease in free cortisol stimulates the pituitary gland to increase production of adrenocorticotropic hormone (ACTH), whereas an increase in free cortisol suppresses ACTH secretion. Normally, the HPA system is characterized by a 24-hour activity rhythm. Serum ACTH levels rise from a low level at 10 p.m. to a peak at 6 a.m. The increased ACTH stimulates adrenal cortical activity, causing plasma cortisol to peak between 2-8 a.m. This increase in cortisol reduces ACTH production and therefore also decreases adrenal cortical synthesis. As a result, plasma corticosteroid levels gradually decrease during the day, reaching their lowest level around midnight. The 24-hour HPA rhythm is lost in Cushing's disease, a condition of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thin skin that bruises easily, weakness and muscle wasting, hypertension, latent diabetes, osteoporosis, and electrolyte imbalance. The same clinical manifestations of hyperadrenocorticism may typically occur during long-term corticosteroid therapy when the medication is administered in divided doses throughout the day. If they occur, disruption of the diurnal rhythm due to maintenance of elevated corticosteroid levels overnight is likely to play an important role in the development of corticosteroid adverse effects. Avoiding persistently elevated plasma concentrations, even for a short period, may help prevent adverse effects. During typical pharmacologic-dose corticosteroid therapy, ACTH production is suppressed along with inhibition of cortisol production by the adrenal cortex. The time required for recovery of normal HPA activity varies according to the dose and duration of treatment. During this period, the patient is sensitive to any stressful circumstances. Although a single morning dose produces significantly less adrenal suppression than prednisolone (10mg) administered in 4 divided doses every 6 hours, there is evidence that, when pharmacologic doses are used, a slight suppressive effect on adrenal activity continues into the following day. In addition, adrenal cortical suppression has been observed for 2 days or longer after a single dose of any corticosteroid. Methylprednisolone, hydrocortisone, prednisone, prednisolone, and other corticosteroids are considered short-acting (a single dose causes adrenocortical suppression for 1¼ to 1½ days) and therefore alternate day therapy is recommended. The following points should be kept in mind when using alternate day therapy. 1) The basic principles and indications for corticosteroid therapy should be applied. The advantages of ADT should not encourage indiscriminate use of corticosteroids. 2) ADT is a treatment technique that should generally be planned for patients requiring long-term corticosteroid therapy. 3) ADT may be used initially for less severe diseases for which corticosteroid therapy is indicated. In more severe diseases, a regimen of high doses divided throughout the day will usually be required to achieve initial control of disease progression. The initial suppressive dose should be continued until a satisfactory clinical response is obtained, usually for 4 to 10 days in many allergic and collagen diseases. It is important to keep the initial suppressive dose period as short as possible, particularly if continued use of alternate day therapy is intended. Once control is achieved, two approaches are possible. ① Switch to ADT and gradually reduce the amount of corticosteroid given every other day. ② Reduce the daily corticosteroid dose to the minimum effective level as soon as possible, according to control of disease progression, and then change to an alternate day schedule. Theoretically, approach ① is more desirable. 4) Because of the advantages of ADT, this form of treatment is desirable for patients who have been taking corticosteroids daily for a long time (for example, rheumatoid arthritis). These patients may already have suppression of the HPA axis, so establishing an ADT regimen may be difficult and is not always successful. However, regular attempts to switch are recommended. If this is difficult, it is preferable to administer 3 or even 4 times the daily dose every other day rather than merely doubling the daily dose. Once the patient is controlled again, an attempt should be made to reduce this dose to the minimum. 5) As noted above, some corticosteroids are not recommended for alternate day therapy because they suppress adrenal function for a prolonged period (for example, dexamethasone, betamethasone). 6) Adrenal cortical activity is greatest from 2 a.m. to 8 a.m. and lowest from 4 p.m. to midnight. When administered during the period of greatest activity (in the morning), exogenous corticosteroids suppress adrenal cortical activity the least. 7) As with any treatment setting, it is important to provide individualized and appropriate treatment for each patient when using ADT. Complete control of symptoms is not possible in every patient. Explaining the advantages of ADT will help patients understand and tolerate unstable symptoms that may occur later in the day on days when corticosteroids are not administered. If necessary, other symptomatic treatments may be added or increased during this period. 8) If an acute exacerbation occurs during the course of the disease, it may be necessary to return to a fully suppressive dose of corticosteroids divided throughout the day to achieve control. Once control is achieved, the established alternate day regimen may be tried again. 9) Although many adverse effects of corticosteroid therapy may be minimized with ADT, as in any treatment setting, the physician should carefully consider the benefit-risk ratio of treatment for each patient in whom corticosteroid therapy is being considered.

This medication should not be used in certain patients. For instance, it should not be given to those allergic to this drug or its components, those with untreatable infections, or those with herpes simplex, herpes zoster, or varicella. Additionally, patients receiving live vaccines or with genetic problems like lactose intolerance should not use this medication. Caution is required when administering this drug to patients with certain conditions including glaucoma, tuberculosis, keratitis, cataracts, electrolyte imbalances, hypertension, thrombosis, or those who have had recent surgery; symptoms may worsen in these patients. Various side effects may occur during the administration of this drug, including edema, increased blood pressure, muscle weakness, gastrointestinal issues, skin changes, mental symptoms, endocrine abnormalities, and eye problems, so careful monitoring is needed. Long-term use may lead to decreased adrenal function; abrupt discontinuation can be dangerous, so the dosage should be gradually reduced. Furthermore, there may be increased susceptibility to infections, thus special attention to infection prevention is necessary. This drug can interact with various other medications, so it is essential to inform the doctor or pharmacist about any other medicines being taken. Pregnant or nursing women should take this medication cautiously under medical judgment, as it may affect the fetus or baby. When administering to children or the elderly, minimal effective doses should be used and their conditions closely monitored due to the risk of growth delay or side effects. Finally, contracting chickenpox or measles while taking this medication can be very dangerous, hence a careful assessment of medical history and vaccination status is required with thorough attention to infection prevention.

Edema, sodium retention, potassium loss, fluid retention, hypokalemic alkalosis, congestive heart failure, hypertension, myasthenia, aseptic necrosis of the femoral and humeral epiphyses, steroid myopathy, muscle mass loss, pathologic fractures of the pelvis, osteoporosis, vertebral compression fractures, arthralgia, tendon rupture, increased ALT, increased AST, increased ALP, nausea, dry mouth, vomiting, gastric pain, loss of appetite, increased appetite, peptic ulcer, abdominal distension, pancreatitis, ulcerative esophagitis, diarrhea, delayed wound healing, facial erythema, thin and fragile skin, abnormal sweating, petechial hemorrhage, purpura, skin reaction suppression phenomenon, purpura, acne, hirsutism, hair loss, pigmentation, nipple swelling, increased intracranial pressure, convulsions, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth suppression in children, symptoms of latent diabetes, secondary adrenal insufficiency, pituitary non-responsiveness, decreased glucose tolerance, increased insulin or oral antidiabetic agent requirements, suppression of adrenocorticotropic hormone secretion, increased intraocular pressure, glaucoma, posterior capsule cataract, secondary infections of the eyes, central serous chorioretinopathy, retinal disorders, proptosis, negative nitrogen balance due to protein catabolism, immune system disorders, allergic reactions, shock, urticaria, anaphylactic reaction, hypersensitivity reactions

This medication should be stored in a tightly closed container to protect it from air and moisture and should be kept at room temperature between 1°C and 30°C. Therefore, it is advisable to avoid extremely hot or cold places and to keep it in a cool area away from direct sunlight.

Appearance

White oval-shaped tablet

Package unit

30 tablets/bottle, 500 tablets/bottle