Misolone Tablet (Methylprednisolone)

Adult dosage

1. The initial dosage may vary from 4mg to 48mg per day of methylprednisolone, depending on the symptoms of the specific disease. A low dose is generally 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 obtained. If satisfactory clinical results are not achieved after a reasonable period, discontinue administration and switch to another appropriate treatment. The dose must be determined individually according to the various diseases being treated and the patient's response. After an adequate response is achieved, determine an appropriate maintenance dose by reducing the initial dose at suitable intervals until the lowest dose that maintains an adequate clinical response is reached. Continuous monitoring of the dosage is required. Circumstances that may require dosage adjustment include remission or worsening of the disease, individual patient response to the medication, and the effect on the patient of exposure to stressful situations 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 a period sufficient to achieve satisfactory control of 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 (4mg of methylprednisolone is equivalent to 5mg of prednisolone). 3. ADT (Alternate Day Therapy) Alternate day therapy is a regimen in which twice the daily dose is administered on one morning out of every two days. The purpose of this regimen is to enhance the effects of corticosteroids in patients requiring 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 allows near-normal restoration of hypothalamic-pituitary-adrenal (HPA) activity on the days corticosteroids are not administered. A brief overview of HPA physiology may help explain this rationale. Free cortisol acts primarily through the hypothalamus, so 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 increase in ACTH stimulates adrenal cortical activity, causing plasma cortisol to peak between 2-8 a.m. This increase in cortisol reduces ACTH production and thus also reduces 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 absent in Cushing's disease, a condition of adrenal cortical hyperfunction characterized by obesity with central fat distribution, thin skin that bruises easily, weakness and muscle wasting, hypertension, latent diabetes, osteoporosis, and electrolyte imbalance. The clinical manifestations of the same hyperadrenocorticism may typically occur during long-term corticosteroid therapy administered in divided doses throughout the day. If they occur, disruption of the diurnal rhythm due to sustained elevated corticosteroid levels during the night is likely to play an important role in the development of corticosteroid adverse effects. Avoiding continuously 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 situation. Although a single morning dose causes significantly less adrenal suppression than taking prednisolone (10mg) in 4 divided doses every 6 hours, there is evidence that even a slight suppressive effect on adrenal activity from pharmacologic doses continues into the following day. In addition, a single dose of any corticosteroid has been shown to suppress the adrenal cortex for 2 days or longer. Other corticosteroids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered short-acting (a single dose produces adrenal cortical suppression for 1¼ to 1½ days) and are therefore suitable for alternate day therapy. The following points should be kept in mind when using alternate day therapy. 1) The fundamental 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) For less severe diseases for which corticosteroid therapy is indicated, ADT may be used initially. For more severe diseases, a regimen of high doses divided throughout the day will usually be required for 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, either of the following approaches may be used. ① Switch to ADT and gradually reduce the amount of corticosteroid given every other day. ② Depending on control of disease progression, reduce the daily corticosteroid dose to the minimum effective dose as soon as possible, and then switch to an alternate day schedule. In theory, approach ① is preferable. 4) Because of the advantages of ADT, this form of treatment is desirable for patients who have taken corticosteroids daily for a long time (for example, rheumatoid arthritis). Since the HPA axis may already be suppressed in these patients, establishing ADT may be difficult and is not always successful. However, regular attempts to switch are recommended. If this is difficult, administering 3 or even 4 times the daily dose every other day is preferable to simply doubling the daily dose. Once the patient is again controlled, attempts should be made to reduce this dose to the minimum. 5) As mentioned above, certain corticosteroids suppress adrenal function for a long time and are therefore not recommended for alternate day therapy (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 fluctuating 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 disease progression, 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 must carefully consider the ratio of benefits to risks of treatment in each patient for whom corticosteroid therapy is being considered.

This medication should not be used in patients who have had allergic reactions to this medication or any of its components. In patients with infections, administration without appropriate antibiotics or in patients with systemic fungal infections may worsen the infections. This medication should not be used in patients with viral infections such as herpes simplex, shingles, or chickenpox. Patients receiving live vaccines or attenuated live vaccines should not take this medication. This medication contains lactose and should not be administered to patients with galactose intolerance, congenital lactase deficiency, or glucose-galactose malabsorption. Patients with glaucoma should be administered this medication cautiously, as it may increase intraocular pressure and worsen the condition. Patients with tuberculous diseases or herpes simplex keratitis may also need to exercise caution due to immunosuppressive effects potentially exacerbating symptoms. Patients with posterior subcapsular cataracts should be cautious, as symptoms may worsen due to effects on the lens. Patients with electrolyte imbalances or hypertension should be carefully monitored, as this medication may affect electrolyte metabolism and worsen their condition. Patients with thromboembolic disorders should be monitored, as coagulation may be promoted, exacerbating the condition. Patients who have recently undergone bowel anastomosis should be careful, as wound healing may be delayed. Patients who have experienced acute myocardial infarction should use this medication cautiously as there may be a risk of cardiac complications. Patients with diverticulitis or peptic ulcers may experience worsening symptoms due to decreased mucosal protective effects and impaired tissue recovery. Patients with psychiatric disorders should be monitored carefully, as this medication may affect neurotransmitters in the brain and worsen symptoms. Patients with severe osteoporosis may experience further worsening of osteoporosis due to inhibited bone formation. Patients with infections may have suppressed immune function, increasing the risk of worsening infections. Patients with diabetes may experience elevated blood sugar levels, worsening their condition, thus stringent blood sugar management is necessary. Patients with renal insufficiency or congestive heart failure may have worsened symptoms due to sodium retention. Patients with hypothyroidism should be cautious as the half-life of the medication may be prolonged. Patients with fatty liver disease or fat embolism may experience worsening symptoms, so careful administration is warranted. Patients with severe myasthenia gravis may notice temporary worsening of symptoms upon initial use. Elderly patients may be more susceptible to side effects such as infections, diabetes, osteoporosis, hypertension, cataracts, and glaucoma, thus should be carefully monitored during administration. Long-term use of this medication may lead to adrenal insufficiency or withdrawal symptoms, so it should not be stopped abruptly but rather tapered off gradually. Due to immunosuppressive effects, the risk of infectious diseases like varicella or measles is increased, therefore exposure should be avoided, and immediate treatment is necessary if infection occurs. During treatment with this medication, vaccination with live vaccines should be avoided, and other vaccinations should be decided carefully. This medication may interact with various other medications, so it is essential to consult with a physician or pharmacist if taking other drugs concurrently. During pregnancy, this medication may affect the fetus, so it is necessary to consult a physician before use if pregnant or potentially pregnant. During breastfeeding, this medication may transfer to breast milk, so it is advisable to discontinue breastfeeding. In children, side effects such as growth retardation may occur, thus the minimum effective dose should be used and growth should be closely monitored. During treatment with this medication, side effects such as edema, muscle weakness, gastrointestinal problems, skin changes, and neurological symptoms may occur, so any abnormal symptoms should be reported to medical personnel immediately.

Edema, sodium retention, potassium loss, fluid retention, hypokalemic metabolic alkalosis, congestive heart failure, hypertension, myasthenia, aseptic necrosis of the femoral and humeral heads, steroid myopathy, muscle wasting, pathologic fracture of the pelvis, osteoporosis, vertebral compression fracture, arthralgia, tendon rupture, ALT increase, AST increase, ALP increase, nausea, thirst, vomiting, abdominal pain, anorexia, increased appetite, peptic ulcer, abdominal distension, pancreatitis, esophagitis, diarrhea, delayed wound healing, facial erythema, thin and fragile skin, abnormal sweating, petechiae, purpura, skin reaction suppression, purpura, acne, hirsutism, hair loss, pigmentation, nipple edema, increased intracranial pressure, seizures, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth suppression in children, symptoms of latent diabetes mellitus, secondary adrenal insufficiency, pituitary unresponsiveness, impaired glucose tolerance, increased requirements for insulin or oral hypoglycemic agents, suppression of adrenocorticotropic hormone secretion, increased intraocular pressure, glaucoma, subcapsular cataract, secondary eye infections due to fungi or viruses, retinal disturbances, exophthalmos, negative nitrogen balance due to protein catabolism, immune system disorders, allergic reactions, shock, urticaria, anaphylactic reactions, hypersensitivity reactions

This medication should be stored in a tightly closed container to protect it from air and moisture, at room temperature between 1 and 30 degrees Celsius. It is advisable to keep it away from direct sunlight and high temperatures, and out of reach of children.

Appearance

White oval tablet

Package unit

30 tablets/bottle, 500 tablets/bottle