Samsung Methylprednisolone Tablet 4 mg

Adult use

1. The initial dose 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 obtained. If satisfactory clinical results are not achieved after a reasonable period, discontinue administration and switch to another appropriate treatment. 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. Continuous monitoring of the dose is required. Dose adjustment may be necessary if the disease improves or worsens, if the individual patient’s response to the drug changes, or if the patient is exposed to stress unrelated 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 meet the patient's needs. After long-term treatment, gradual dose reduction is recommended when discontinuing the drug. 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 2 days. The purpose of this regimen is to enhance the effects of corticosteroids in patients who require long-term drug treatment 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 persist longer than their physical presence and metabolic effects; and 2) Taking corticosteroids in the morning every other day allows almost normal hypothalamus-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. The increased ACTH level stimulates adrenal cortical activity, causing plasma cortisol levels to peak between 2-8 a.m. This increase in cortisol decreases ACTH production and consequently reduces adrenal cortical synthesis. As a result, plasma corticosteroid levels 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 hyperadrenocorticism with symptoms such as obesity with centripetal fat distribution, thin skin that bruises easily, weakness and muscle wasting, hypertension, latent diabetes, osteoporosis, and electrolyte imbalance. The same clinical symptoms of hyperadrenocorticism can typically occur during long-term corticosteroid drug therapy administered in divided doses throughout the day. If these symptoms 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 persistently 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, a slight inhibitory 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. Methylprednisolone, hydrocortisone, prednisone, prednisolone, and other corticosteroids are considered short-acting (a single dose suppresses the adrenal cortex 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 drug therapy. 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 divided throughout the day will usually be required to control disease progression initially. 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 ongoing 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, then switch to an alternate-day schedule. In theory, 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 these patients may already have HPA axis suppression, establishing an ADT regimen 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 under control, an attempt should be made to reduce this dose to the minimum. 5) As mentioned above, certain 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 maximal from 2 a.m. to 8 a.m. and minimal 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 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 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 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 consider the benefit-risk ratio of treatment for each patient in whom corticosteroid therapy is being considered.

This medication should not be used in certain patients. For example, individuals who are allergic to this medication or its components, patients with infections without effective antibiotics or systemic fungal infections, those with herpes simplex, herpes zoster, chickenpox, and individuals receiving live vaccines should not take this medication. Additionally, patients with genetic lactose intolerance should also avoid this medication, as it contains lactose. Some patients need to use this medication with caution. It should be particularly noted for patients with glaucoma, tuberculosis, keratitis, cataracts, electrolyte abnormalities, hypertension, thrombosis, recent gastrointestinal surgery, history of acute myocardial infarction, diverticulitis, peptic ulcers, mental disorders, osteoporosis, infections, diabetes, kidney failure, hypothyroidism, fatty liver, fat embolism, severe myasthenia gravis, elderly patients, and those with ulcerative colitis. When taking this medication, various side effects may occur, so careful observation is required. Possible side effects include edema, increased blood pressure, muscle weakness, osteoporosis, gastrointestinal issues, skin changes, neuropsychological symptoms, endocrine abnormalities, and eye problems. Long-term use may result in adrenal insufficiency, and abruptly stopping the medication can cause severe withdrawal symptoms, so the dosage should be reduced slowly. Also, one may become more susceptible to infections, so preventive measures against infections should be taken. This medication may interact with other drugs, and dose adjustments or caution may be necessary depending on the co-administered medications. Special attention should be paid when used with drugs that may affect heart rhythm, anticoagulants, hypoglycemic agents, diuretics, antibiotics, anticancer drugs, etc. Pregnant or breastfeeding women should take this medication cautiously under medical guidance due to potential side effects on the fetus or newborn and are advised to stop breast-feeding. In children or adolescents, side effects such as growth retardation may occur, so it should be used at the lowest effective dose, and elderly patients have a higher risk of side effects, requiring special caution. Finally, live vaccines should be avoided while taking this medication, and care should be taken as immunity to infections may be weakened.

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, pathologic fractures of the ileum, osteoporosis, vertebral compression fractures, arthralgia, tendon rupture, increased ALT, increased AST, increased ALP, nausea, dry mouth, vomiting, gastric pain, anorexia, 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, papill edema, increased intracranial pressure, convulsions, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, pediatric growth suppression, latent diabetes symptoms, secondary adrenal insufficiency, pituitary non-responsiveness, decreased glucose tolerance, increased requirement for insulin or oral hypoglycemics, suppression of adrenocorticotropic hormone secretion, increased intraocular pressure, glaucoma, posterior capsule opacification, secondary eye infections, 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 closed container. Also, avoid storing it in extremely hot or cold places, and it is safe to store it at room temperature between 1 and 30 degrees Celsius.

Appearance

White round tablet

Package unit

30 tablets/bottle, 500 tablets/bottle