Spolon Tablet (Methylprednisolone)

Adult dosage

1. The initial dosage 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, but a high initial dose may be required in special patients. The initial dose should be maintained or adjusted until a satisfactory response is obtained. If a satisfactory clinical result is not achieved 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, 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. Continuous monitoring of the dose is required. Situations that may require dose adjustment include remission or worsening of the disease, the individual patient's response to the drug, 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 provide satisfactory control of the patient's condition. After long-term treatment, gradual reduction of the dose is recommended when discontinuing the drug. 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 in the morning on one day out of every two. The purpose of this regimen is to enhance the effects of corticosteroids in patients requiring long-term drug therapy and to minimize adverse reactions 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 persist longer than their physical presence and metabolic effects, and 2) Taking corticosteroids in the morning every other day restores almost normal hypothalamus-pituitary-adrenal (HPA) activity on the days when corticosteroids are not administered. A brief summary 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 an activity rhythm over 24 hours. Serum ACTH levels rise from a low level at 10 p.m. to a peak at 6 a.m. The increased ACTH levels stimulate adrenal cortical activity, causing plasma cortisol to reach its 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 hyperadrenocorticism characterized by obesity with centripetal 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 maintenance of elevated corticosteroid levels during the night is likely to play an important role in the development of corticosteroid adverse reactions. Avoiding continuously elevated plasma concentrations, even for a short period, may help prevent adverse reactions. During typical pharmacologic-dose corticosteroid therapy, ACTH production is suppressed along with suppression of cortisol production by the adrenal cortex. The time required to recover 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 throughout the day, 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 more. Methylprednisolone, hydrocortisone, prednisone, prednisolone, and other corticosteroids are considered short-acting (a single dose produces 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 be considered as a basic plan for patients requiring long-term corticosteroid drug therapy. 3) For less severe diseases with indications for corticosteroid therapy, ADT may be used initially. For more severe diseases, a regimen of high doses 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 obtained, 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 has been 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 level as soon as possible, 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 taken corticosteroids daily for a long period (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 make the change 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 long time (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) When using ADT, as in all treatment settings, it is important 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 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 in divided doses throughout the day for control. Once control has been achieved, the established alternate-day regimen may be tried again. 9) Although many adverse reactions to 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 for whom corticosteroid therapy is being considered.

This medication should not be used in certain patients. For example, individuals allergic to this drug or its components, patients with infections that are difficult to treat, and those with herpes simplex, herpes zoster, or chickenpox should not receive this medication. Additionally, patients who are receiving live vaccines or have genetic issues such as lactose intolerance should not use this medication. This drug should be used cautiously in some patients. Those with conditions such as glaucoma or tuberculosis, peptic ulcers, psychiatric disorders, osteoporosis, hypertension, or heart failure, or those who have had recent surgery should be careful as this medication may exacerbate symptoms. Various side effects such as fluid and electrolyte imbalance, muscle weakness, gastrointestinal issues, skin changes, and neuropsychiatric symptoms may appear, so immediate consultation with healthcare professionals is advised if symptoms occur. Long-term use may lead to adrenal insufficiency, so it should not be stopped abruptly and the dosage should be gradually reduced, especially during stressful situations such as surgery or infections. As it suppresses immune function, it may lead to increased susceptibility to infections, so caution is particularly advised against exposure to infectious diseases such as chickenpox or measles. There are many interactions when used with other medications, so it is crucial to inform healthcare providers about any other medications being taken, and dosage adjustment may be needed when taken with blood pressure medications, diabetes medications, anticoagulants, etc. Women who are pregnant or breastfeeding are advised against using this medication except in special cases, as it may affect the fetus or newborn. In children and the elderly, the risk of growth delay or infection may increase, so it should be used cautiously at the minimum effective dose. Finally, during the use of this medication, regular check-ups and strict adherence to healthcare professionals' instructions are essential, and any unusual symptoms should be reported immediately.

Edema, sodium retention, potassium loss, fluid retention, hypokalemic alkalosis, congestive heart failure, hypertension, myasthenia, aseptic necrosis of the femoral and humeral heads, steroid myopathy, loss of muscle mass, pathological fractures of the iliac bone, osteoporosis, vertebral compression fractures, 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, ulcerative esophagitis, diarrhea, delayed wound healing, facial erythema, thin and fragile skin, abnormal sweating, petechiae, purpura, skin reaction suppression, purpura, acne, hirsutism, hair loss, hyperpigmentation, nipple edema, increased intracranial pressure, convulsions, dizziness, headache, insomnia, anxiety, depression, Cushing's syndrome, menstrual irregularities, growth retardation in children, signs of latent diabetes mellitus, secondary adrenal insufficiency, pituitary unresponsiveness, decreased glucose tolerance, increased demand for insulin or oral hypoglycemic agents, suppression of adrenocorticotropic hormone secretion, increased intraocular pressure, glaucoma, posterior capsule cataract, secondary infections of the eye, central serous chorioretinopathy, retinal disorders, proptosis, 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. Additionally, it is best to store the medication at room temperature between 1 to 30 degrees Celsius. Proper storage will maintain the efficacy and safety of the medication.

Appearance

White round tablet

Package unit

30 tablets/bottle, 200 tablets/bottle, 300 tablets/bottle