Selcor 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 certain patients. The initial dose should be maintained or adjusted until a satisfactory response is achieved. If satisfactory clinical results are not obtained 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, the 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 dose adjustment include improvement or worsening of the disease, an individual patient's response to the medication, and the effect on the patient of exposure to stressful circumstances that have no direct effect on 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 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 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 persist longer than their physical presence and metabolic effects, and 2) Taking corticosteroids in the morning every other day allows almost normal hypothalamic-pituitary-adrenal (HPA) activity to be reestablished on 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 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 levels stimulate adrenal cortical activity, causing plasma cortisol to reach a peak between 2-8 a.m. This increase in cortisol reduces ACTH production and thus also decreases adrenal cortical synthesis. As a result, plasma corticosteroid levels gradually decrease throughout the day, reaching their lowest level around midnight. The 24-hour HPA rhythm is absent in Cushing's disease, a condition of adrenocortical 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 can typically occur during long-term corticosteroid therapy when the medication is divided into doses throughout the day. If they occur, disruption of the diurnal rhythm due to maintenance of elevated corticosteroid levels overnight is likely to play an important role in the development of corticosteroid adverse effects. Avoiding persistently elevated plasma concentrations, even for a short period, may help prevent adverse effects. During treatment with typical pharmacologic doses of corticosteroids, ACTH production is suppressed along with the 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, there is evidence that, when pharmacologic doses are used, some suppression of adrenal activity continues into the following day. In addition, even 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 adrenocortical 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 benefits 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 achieved, 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 level as soon as possible, and then switch to an alternate-day schedule. In theory, approach ① is preferable. 4) Given 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). Because these patients may already have suppression of the HPA axis, establishing ADT may be difficult and is not always 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 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 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) As with any treatment setting, when using ADT 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 when they are not taking 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 fully suppressive doses 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 can be minimized with ADT, as in any treatment setting, the physician must carefully consider the benefit-risk ratio for each patient being considered for corticosteroid treatment.

This drug should not be used in certain patients. For example, patients with an allergy to this drug or its components, or those with a history of such an allergy, patients with infections for which effective antimicrobials are not available, patients with herpes simplex or herpes zoster, chickenpox patients, those receiving live vaccines or attenuated live vaccines, and patients with lactose intolerance or specific inherited metabolic disorders should not be administered this medication. Additionally, patients with diseases such as glaucoma, tuberculosis, cataracts, electrolyte disturbances, hypertension, thrombosis, recent surgery, myocardial infarction, diverticulitis, peptic ulcer, mental illness, osteoporosis, or infections, diabetes, renal failure, hypothyroidism, fatty liver, severe myasthenia gravis, the elderly, epilepsy, and ulcerative colitis should be used with particular caution and under close supervision. This medication may cause various side effects such as edema, hypertension, muscle weakness, osteoporosis, gastrointestinal disturbances, skin changes, headache, depression, endocrine abnormalities, and increased ocular pressure, so symptoms should be carefully monitored. Long-term use may result in adrenal insufficiency, and sudden discontinuation may lead to severe withdrawal symptoms, so it should be gradually reduced. There may be an increased susceptibility to infections, and if an infection is suspected or occurs, immediate treatment should be sought. Moreover, during treatment, there may be interactions with certain medications, so if other medications are being taken, it is essential to consult a healthcare professional. Women who are pregnant or breastfeeding should use this medication only after consulting a doctor, as it may affect the fetus or newborn, and breastfeeding is best discontinued during treatment. For children and adolescents, the minimum effective dose should be used as it may affect growth, and their growth status should be carefully monitored. Elderly patients are at higher risk for side effects such as infection, diabetes, osteoporosis, hypertension, cataracts, glaucoma, and should take special care. Finally, this medication has immunosuppressive effects, and caution is necessary during vaccination, with extra care needed for infection prevention.

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 atrophy, pathologic fractures of the pelvis, osteoporosis, vertebral compression fractures, arthralgia, tendon rupture, elevated ALT, elevated AST, elevated ALP, nausea, dry mouth, vomiting, gastric 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, suppressed skin reactions, purpura, acne, hirsutism, hair loss, pigmentation, increased intracranial pressure, papilledema, convulsions, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth inhibition, symptoms of latent diabetes mellitus, adrenal insufficiency, pituitary unresponsiveness, impaired glucose tolerance, increased insulin requirement, suppression of adrenocorticotropic hormone secretion, increased intraocular pressure, glaucoma, posterior capsule opacification, secondary 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 sealed container to protect it from air and moisture. It is essential to keep the storage temperature between 1 to 30 degrees Celsius (room temperature).

Appearance

White round tablet

Package unit

30 tablets/bottle, 300 tablets/bottle