Methylsolone Tablet 4mg (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, but a high initial dose may be required in certain patients. The initial dose must be maintained or adjusted until a satisfactory response is achieved. If a satisfactory clinical result is not obtained after a reasonable period, administration should be discontinued and another appropriate treatment initiated. The dose must be determined individually according to the various diseases being treated and the patient's response. After an adequate response is achieved, an 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. Ongoing monitoring of the dosage is required. Situations that may require dosage adjustment include improvement or worsening of the disease, individual differences in the patient's response 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 a period sufficient to achieve a satisfactory response in the patient's condition. After long-term treatment, gradual reduction of the dose is recommended when discontinuing the medication. 2. Multiple sclerosis For the 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 other day. 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 hypothalamic-pituitary-adrenal suppression, a 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 last 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 when corticosteroids are not administered. A brief overview of HPA physiology may help explain this rationale. Free cortisol acts mainly 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 level at 6 a.m. The increased ACTH levels stimulate adrenal cortical activity, causing plasma cortisol levels to peak between 2-8 a.m. This increase in cortisol reduces ACTH production and therefore also reduces adrenal cortical synthesis. As a result, plasma corticosteroid levels gradually decline during the day, reaching a minimum around midnight. The 24-hour HPA rhythm is absent in Cushing's disease, a condition of adrenal cortical 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 administered in divided doses throughout the day. If these manifestations 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. Even a brief period without continuously elevated plasma concentrations may help prevent adverse effects. During treatment with typical pharmacologic doses of corticosteroids, 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, patients are susceptible to any stressful circumstances. Although a single morning dose causes considerably less adrenal suppression than taking prednisolone (10mg) 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, 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 causes adrenal cortical suppression for 1¼ to 1½ days) and are therefore recommended for alternate-day therapy. 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) 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 continuous 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 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. 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). Since the HPA axis may already be suppressed in these patients, 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 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, 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 highest from 2 a.m. to 8 a.m. and lowest from 4 p.m. to midnight. When administered during the period of peak 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 when they are not receiving corticosteroids. 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 must carefully weigh the benefit-risk ratio of treatment for each patient in whom corticosteroid therapy is being considered.

This drug should not be used in certain patients. For example, it should not be administered to patients who are allergic to this drug or its ingredients or have infections that cannot be effectively treated with antibiotics. Patients with herpes simplex, shingles, chickenpox, or those receiving live vaccines should not use this medication. This drug contains lactose, so patients with lactose intolerance or related genetic conditions should not take it. This drug should be used cautiously in some patients. For instance, patients with glaucoma, tuberculosis, keratitis, posterior capsule opacification, electrolyte imbalances, hypertension, thrombosis, recent surgery, and heart disease require special attention. Likewise, patients with diabetes, osteoporosis, renal insufficiency, hypothyroidism, fatty liver, elderly patients, and those with epilepsy should have their conditions closely monitored when using this medication. This drug can cause various side effects; therefore, if any unusual symptoms occur during use, immediate consultation with healthcare professionals is recommended. Reported side effects include edema, increased blood pressure, muscle weakness, osteoporosis, gastrointestinal issues, skin changes, neurological disturbances, endocrine changes, and eye-related problems. When this drug is used for extended periods, sudden discontinuation can be dangerous; therefore, dosages should be gradually reduced, and doses may need to be temporarily increased in stressful situations. Additionally, it suppresses immune function, raising the risk of infections, so special care must be taken to prevent infections. This drug may interact with various other medications, so patients taking other drugs should inform their physician or pharmacist. Special caution is advised when used alongside heart-related drugs, antibiotics, anticoagulants, diuretics, and anticonvulsants. Women who are pregnant or breastfeeding should carefully consider the benefits and risks of this medication, as it may affect the fetus or newborn; it is advisable to discontinue breastfeeding. In children, side effects such as growth retardation may occur, so the minimum effective dose should be used and growth should be closely monitored. Elderly patients are at an increased risk of side effects such as infections, osteoporosis, hypertension, and glaucoma, necessitating careful monitoring during use. Finally, this drug may reduce vaccine effectiveness, so patients with planned vaccinations should consult with healthcare professionals, and caution is recommended during skin tests.

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 wasting, pathologic fractures of the pelvis, osteoporosis, spinal compression fractures, arthralgia, tendon rupture, elevated ALT, elevated AST, elevated ALP, nausea, thirst, vomiting, abdominal 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, petechiae, purpura, skin reaction suppression, purpura, acne, hirsutism, hair loss, pigmentation, nipple swelling, increased intracranial pressure, convulsions, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth retardation in children, latent diabetes symptoms, secondary adrenal insufficiency, pituitary apoplexy, decreased glucose tolerance, increased requirements for insulin or oral hypoglycemic agents, suppression of adrenocorticotropic hormone secretion, increased intraocular pressure, glaucoma, posterior capsule cataract, secondary eye infections, retinal disorders, exophthalmos, negative nitrogen balance, immune system disorders, allergic reactions, shock, urticaria, anaphylactic reactions, hypersensitivity reactions

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance

White oval tablet

Package unit

30 tablets/bottle, 500 tablets/bottle