Boryeong Methylprednisolone Tablets

Adult dosage

1. The initial dosage may vary from 4mg to 48mg of methylprednisolone per day, 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 must 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 must be individualized according to the various diseases being treated and the patient's responsiveness. After an adequate response is obtained, 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. Continuous monitoring of the dosage is required. Situations that may require dosage adjustment include improvement or worsening of the disease, individual differences in the patient's responsiveness to the drug, and the effect on the patient of exposure to stressful circumstances that do not directly affect the symptoms of the disease being treated. In the latter situation, it may be necessary to increase the dose for a period sufficient to achieve a satisfactory effect on the patient's condition. 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 out of every two 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 suppression of the pituitary-adrenal axis, 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 the days when corticosteroids are not administered. A brief review 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 rise in ACTH stimulates adrenocortical activity, causing plasma cortisol to peak between 2-8 a.m. This increase in cortisol reduces ACTH production and consequently decreases adrenal cortical synthesis. As a result, plasma corticosteroid levels gradually decline over the course of the day, reaching a minimum around midnight. The 24-hour rhythmic axis of the HPA system is absent in Cushing's disease, a condition of adrenocortical hyperfunction characterized by 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 signs 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 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 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 taking prednisolone (10mg) in 4 divided doses every 6 hours throughout the day, there is evidence that, at pharmacologic doses, a slight suppressive 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. Other corticosteroids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered short-acting (a single dose causes 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 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 who require long-term corticosteroid drug treatment. 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 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 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 options are possible. ① Switch to ADT and gradually reduce the amount of corticosteroid given every other day. ② Reduce the daily corticosteroid dose to the minimum effective level as soon as possible, according to control of disease progression, and then change to an alternate-day schedule. Theoretically, option ① is preferable. 4) Because of the advantages of ADT, this form of treatment is desirable for patients who have taken corticosteroids daily for a long time (for example, rheumatoid arthritis). Since these patients may already have HPA-axis suppression, establishing ADT may be difficult and is not always successful. However, regular attempts to make the change are recommended. If this is difficult, 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, an attempt 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 maximal from 2 a.m. to 8 a.m. and minimal from 4 p.m. to midnight. When administered during the period of maximal activity (in the morning), exogenous corticosteroids suppress adrenocortical 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 advantages of ADT will help patients understand and tolerate unstable symptoms that may occur during the latter part of 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 disease progression, it may be necessary to return to a fully suppressive dose of corticosteroids divided throughout the day for control. Once control has been achieved, the established alternate-day regimen may be tried 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 ratio of benefits to risks of treatment for each patient for whom corticosteroid therapy is being considered.

This medication should not be administered to certain patients. For example, patients who are allergic to this medication or its components, or those who are genetically lactose intolerant should not take this medication. Additionally, patients with infections or systemic fungal infections, herpes simplex, herpes zoster, or chickenpox should exercise caution as this medication may impair immune function and exacerbate infections. Patients receiving live vaccines should also not take this medication. This medication should be administered with caution in some patients. For example, patients with glaucoma, tuberculosis, hypertension, thromboembolic disease, peptic ulcer disease, psychiatric disorders, osteoporosis, diabetes, and renal failure need special attention as this medication may exacerbate symptoms. While taking this medication, side effects such as edema, hypertension, muscle weakness, osteoporosis, indigestion, skin changes, headaches, and depression may occur, so symptoms should be closely monitored. If any abnormal symptoms occur, consult a healthcare professional immediately. In case of long-term use, sudden discontinuation of the medication can lead to serious symptoms such as adrenal insufficiency, so the dosage should be gradually reduced, and in stressful situations such as surgery or infection, the dosage may need to be temporarily increased. This medication may interact with several other drugs, so if other medications are being taken, it is essential to inform healthcare professionals. Caution is especially needed when taken with cardiac medications, antibiotics, diuretics, and hypoglycemics. Pregnant or nursing women should be cautious with this medication as it may affect the fetus or newborn, and it is advisable to discontinue breastfeeding under medical guidance. In children, there may be side effects such as growth retardation, so it should be administered carefully at the minimum effective dose. In the elderly, careful observation is required during administration due to an increased risk of side effects from infections, diabetes, osteoporosis, glaucoma, etc. Finally, during the use of this medication, contracting chickenpox or measles can be very dangerous, so it is essential to check for medical history related to these diseases and vaccination status to prevent infections.

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 wasting, pathological fractures of the iliac bone, osteoporosis, spinal compression fractures, arthralgia, tendon rupture, increased ALT, increased AST, increased ALP, nausea, thirst, vomiting, gastric pain, anorexia, increased appetite, peptic ulcer, abdominal distention, pancreatitis, ulcerative esophagitis, diarrhea, delayed wound healing, facial erythema, thin and fragile skin, abnormal sweating, petechiae, purpura, skin reaction suppression, purpuric rash, acne, excessive hair growth, hair loss, pigmentation, papilledema, increased intracranial pressure, convulsions, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth retardation in children, 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 caused by fungi or viruses, central serous chorioretinopathy, retinal disorders, exophthalmos, negative nitrogen balance, immune system disorders, allergic reactions, shock, urticaria, anaphylactic reaction, hypersensitivity reactions

Store this medication in a tightly sealed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1°C and 30°C at room temperature.

Appearance

White oval-shaped tablet

Package unit

30 tablets/bottle, 500 tablets/bottle