Mepisolone Tablet (Methylprednisolone)

Adult use

The initial dose may vary from 4mg to 48mg per day of 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 a satisfactory clinical result is not obtained after a reasonable period, treatment should be discontinued and another appropriate treatment initiated. The dose should be determined individually according to the various diseases being treated and the patient's response. After an adequate response is obtained, 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. The dose must be monitored continuously. 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 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. 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). Alternate-day therapy means administering twice the daily dose on one morning every 2 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 last longer than their physical presence and metabolic effects; and 2) Taking corticosteroids in the morning on alternate days restores nearly normal hypothalamic-pituitary-adrenal (HPA) activity on days when corticosteroids are not administered. A brief summary 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 decreases ACTH production and consequently reduces adrenal cortical synthesis. Plasma corticosteroid levels therefore gradually decrease during the day, reaching a minimum around midnight. The 24-hour HPA rhythm is absent in Cushing's disease, a condition characterized by hyperfunction of the adrenal cortex, with symptoms including obesity with central 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 they occur, disruption of the diurnal rhythm due to maintenance of 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 suppression 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 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, some suppression of 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. Methylprednisolone, hydrocortisone, prednisone, prednisolone, and other corticosteroids are considered short-acting (a single dose produces adrenal cortical 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 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. In 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 has been 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 preferable. 4) Because of the benefits 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 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 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 when using ADT to provide individualized and appropriate treatment for each patient. Complete control of symptoms is not possible in every patient. Explaining the benefits of ADT will help patients understand and tolerate unstable symptoms that may occur during the latter part of days when they do not receive corticosteroids. 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 has been achieved, the established alternate-day regimen may be attempted 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 ratio of benefits to risks for each patient being considered for corticosteroid treatment.

This medication should not be administered to certain patients. For example, patients who are allergic to this drug or its components, or those with infections without effective antibiotics or systemic fungal infections, should not use it as it may worsen their infection. Additionally, it should not be given to patients with simple herpes, herpes zoster, or varicella, or to those receiving live vaccines, nor to patients with lactose intolerance or genetic issues related to lactose. This drug must be administered with caution to patients with various conditions, such as glaucoma, tuberculous diseases, peptic ulcers, hypertension, thrombosis, or a history of acute myocardial infarction, as it may worsen symptoms. During treatment, various side effects may occur, such as edema, hypertension, muscle weakness, osteoporosis, gastrointestinal symptoms, skin changes, neuropsychiatric symptoms, endocrine abnormalities, and ocular abnormalities; hence, symptoms should be carefully monitored. If used long term, adrenal insufficiency may occur, so abrupt discontinuation should be avoided and dosage should be tapered gradually. In cases of trauma, surgery, or infection, the dosage may need to be temporarily increased. Moreover, this drug may suppress immune function and increase the risk of infections, so care should be taken to avoid exposure to infections such as varicella or measles, and vaccinations may also be limited. Interactions may occur when used in combination with other medications, especially heart-related drugs, anticoagulants, diuretics, antibiotics, and anticonvulsants, so it is important to consult a healthcare professional. Women who are pregnant or breastfeeding should use it cautiously, as it may affect the fetus or newborn, and breastfeeding is recommended to be discontinued. In children, growth retardation may occur, so the minimum effective dose should be used, and growth should be carefully monitored. The elderly are at higher risk for side effects such as infections, diabetes, and osteoporosis, so they should be administered with extra caution. Finally, if a patient receiving this medication becomes infected with varicella or measles, it can lead to fatal outcomes, so it is essential to confirm their medical history and vaccination status and take careful measures to prevent infection.

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, pathological fractures of the iliac bone, osteoporosis, vertebral compression fractures, arthralgia, tendon rupture, increased ALT, increased AST, increased ALP, nausea, dry mouth, vomiting, gastric pain, anorexia, hyperphagia, peptic ulcer, abdominal distension, pancreatitis, ulcerative esophagitis, diarrhea, delayed wound healing, facial erythema, thin and delicate skin, abnormal sweating, petechiae, purpura, suppression of skin reactions, purpura, acne, hirsutism, hair loss, pigmentation, nipple edema, increased intracranial pressure, seizures, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth suppression, symptoms of latent diabetes, secondary adrenal insufficiency, pituitary unresponsiveness, decreased glucose tolerance, increased requirements for insulin or oral hypoglycemic agents, suppression of adrenocorticotropic hormone secretion, increased intraocular pressure, glaucoma, posterior capsule cataract, secondary infections of the eye, retinal disorders, 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 sealed container to protect it from air and moisture. Additionally, it is best to keep it at room temperature, not too hot or too cold, ideally between 1°C and 30°C.

Appearance

White oval-shaped tablet

Package unit

30 tablets/bottle, 500 tablets/bottle