Metisolon Tablets (Methylprednisolone)

Adult dosage

The initial dosage 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 obtained. If a satisfactory clinical outcome is not achieved after a reasonable period, treatment 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. The dose must be monitored continuously. Situations that may require dose adjustment include remission or worsening of the disease, individual patient 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 satisfactorily manage 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 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 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 allows nearly normal hypothalamic-pituitary-adrenal (HPA) activity to be restored on the days when 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. Increased 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 decreases adrenal cortical synthesis. Consequently, 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 characterized by hyperadrenocorticism, with symptoms including 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 they occur, disruption of the diurnal rhythm due to maintenance of elevated corticosteroid levels overnight may 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 therapy 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, the patient is sensitive to any stressful circumstances. Although a single morning dose causes considerably less adrenal suppression than prednisolone (10mg) administered 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. 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 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 therapeutic technique that should generally be considered for patients requiring long-term corticosteroid treatment. 3) For less severe diseases for which corticosteroid therapy is indicated, ADT may be used initially. For more severe conditions, a regimen of high doses administered in divided doses 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 achieved, usually for 4 to 10 days for 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 options 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, then switch to an alternate-day schedule. Theoretically, approach ① is preferable. 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 may not always be successful. However, regular attempts to make the change are recommended. If difficulties arise, 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 controlled again, attempts should be made to reduce this dose to the minimum. 5) As mentioned above, some corticosteroids suppress adrenal function for a long time and are therefore not recommended for alternate-day therapy (for example, dexamethasone, betamethasone). 6) Maximum adrenal cortical activity occurs from 2 a.m. to 8 a.m., and minimum activity from 4 p.m. to midnight. When administered during the period of maximum activity (in the morning), exogenous corticosteroids suppress adrenal cortical activity the least. 7) As with any treatment, 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 disease progression, it may be necessary to return to divided daily doses of corticosteroids at a fully suppressive level 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 with any treatment, the physician must carefully weigh the benefits and risks of treatment for each patient being considered for corticosteroid therapy.

This medication should not be used for certain patients. For example, patients who are allergic to this drug or its components, those with infections without appropriate antibacterial agents, patients with herpes simplex or herpes zoster, chickenpox patients, those undergoing live vaccine administration, and patients with lactose intolerance or certain genetic metabolic disorders should not take this medication. Additionally, patients with various conditions such as glaucoma, tuberculosis, keratitis, cataracts, electrolyte imbalances, hypertension, thrombosis, recent surgery, heart disease, peptic ulcers, mental disorders, or osteoporosis should use this medication with caution. In such cases, it should be administered only in essential situations under the physician's judgment, and the possibility of side effects should be closely monitored. This medication may cause various side effects including edema, increased blood pressure, muscle weakness, osteoporosis, gastrointestinal problems, skin changes, psychiatric symptoms, endocrine disorders, and eye diseases. Therefore, during administration, it is essential to carefully monitor for these symptoms and inform medical staff immediately if any abnormalities occur. Long-term use of this medication may lead to adrenal gland suppression, so do not stop taking it suddenly, but taper the dosage gradually. Also, be particularly careful about infection risks as they may increase, and avoid exposure to infections such as chickenpox or measles. This medication may interact with other drugs, so if taking other medications, it is essential to inform medical staff and adjust the dosage or monitor for side effects as necessary when combined. Women who are pregnant or breastfeeding should decide on the administration of this medication cautiously, as it may affect the fetus or newborn, and discontinuing breastfeeding is recommended. Caution should be taken when administering this medication to children or the elderly due to an increased risk of growth suppression or side effects, and regular monitoring is required. Finally, while taking this medication, it is important to regularly check health status and follow the physician's instructions.

Edema, sodium retention, potassium loss, fluid retention, hypokalemic alkalosis, congestive heart failure, hypertension, myasthenia, aseptic necrosis of the femoral and humeral epiphysis, steroid myopathy, loss of muscle mass, pathologic fracture of the pelvis, osteoporosis, spinal compression fracture, arthralgia, tendon rupture, elevated ALT, elevated AST, elevated ALP, nausea, dry mouth, vomiting, stomach pain, loss of appetite, increased appetite, peptic ulcer, abdominal distension, pancreatitis, esophagitis, diarrhea, delayed wound healing, facial erythema, thin and fragile skin, abnormal sweating, petechiae, purpura, cutaneous reaction suppression, petechiae, acne, hirsutism, hair loss, pigmentation, papilledema, increased intracranial pressure, seizures, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, pediatric growth suppression, latent diabetes symptoms, secondary adrenal insufficiency, pituitary unresponsiveness, decreased glucose tolerance, increased demand for insulin or oral hypoglycemic agents, suppression of adrenocorticotropic hormone secretion, ocular hypertension, glaucoma, posterior capsule cataract, secondary eye infection due to fungus or virus, central serous chorioretinopathy, retinal disorders, exophthalmos, negative nitrogen balance, immune system disorders, allergic reactions, shock, urticaria, anaphylactic reactions, hypersensitivity reactions

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1 degree to 30 degrees Celsius at room temperature to safely maintain the effectiveness of the medication.

Appearance

White oval-shaped tablets

Package unit

30 tablets/bottle, 300 tablets/bottle, 500 tablets/bottle