Mediron Tablets (Methylprednisolone)

Adult dosage

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 conditions that are not severe, although 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 a satisfactory clinical result is not obtained 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 has been achieved, determine an appropriate maintenance dose by reducing the initial dose at suitable intervals until the lowest dose that maintains an adequate clinical response is reached. Ongoing monitoring of the dose is required. Circumstances 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 achieve a satisfactory patient condition. After long-term treatment, gradual dose reduction 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 on one morning out of every two days. The purpose of this regimen is to enhance the effects of corticosteroids in patients requiring long-term drug therapy 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 near-normal hypothalamic-pituitary-adrenal (HPA) activity to be re-established on days when corticosteroids are not administered. A brief summary of HPA physiology may help explain this rationale. Free cortisol acts primarily 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 adrenocortical activity, causing plasma cortisol to peak between 2-8 a.m. This increase in cortisol reduces ACTH production and consequently decreases adrenocortical synthesis. This gradually lowers plasma corticosteroid levels over the course of the day, reaching a minimum 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 symptoms 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 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 treatment 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 taking prednisolone (10mg) in 4 divided doses every 6 hours throughout the day, there is evidence that pharmacologic doses have a slight suppressive effect on adrenal activity that 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 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 generally be planned for patients requiring long-term corticosteroid drug therapy. 3) ADT may be used initially for less severe diseases for which corticosteroid therapy is indicated. 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 is achieved, two approaches 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 switch to an alternate day schedule. In theory, 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 time (for example, rheumatoid arthritis). Since the HPA axis may already be suppressed in these patients, establishing an ADT regimen may be difficult and is not always successful. However, regular attempts to switch are recommended. If this proves difficult, it is preferable to administer 3 times or even 4 times the daily dose every other day rather than simply doubling the daily dose. Once the patient is controlled again, attempt 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 adrenocortical 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 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 corticosteroid dose divided throughout the day to achieve control. Once control is achieved, an attempt may be made to resume the established alternate day regimen. 9) Although many adverse effects of 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 being considered for corticosteroid therapy.

This medication should not be used in patients who are hypersensitive to this drug or its components. Infections without effective antimicrobials or systemic fungal infections may worsen, so it should not be administered to these patients. It should not be used in patients with herpes simplex, shingles, or chickenpox due to an increased risk of infection. Patients receiving live vaccines or attenuated live vaccines should not use this medication. As it contains lactose, it should not be administered to patients with genetic conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Patients with specific conditions such as glaucoma, tuberculosis, or posterior subcapsular cataracts should use this drug with caution as their symptoms may worsen. Patients with electrolyte imbalances, hypertension, or thrombosis must be cautious as their conditions may deteriorate with this medication. Recent surgery patients or those with histories of acute myocardial infarction should also be careful as they may experience delayed wound healing or heart-related issues. Patients with peptic ulcer, mental illness, or severe osteoporosis should be treated cautiously as they may experience worsening symptoms. Various conditions such as infections, diabetes, renal failure, congestive heart failure, hypothyroidism, fatty liver, severe myasthenia gravis, the elderly, and patients with epilepsy need caution as their conditions may worsen with this drug. This medication can cause various side effects such as edema, sodium retention, potassium loss, myopathy, osteoporosis, gastrointestinal symptoms, skin changes, neuropsychiatric symptoms, and endocrine disorders, so symptoms need to be monitored closely. Particularly with long-term use, side effects such as adrenal insufficiency, increased blood pressure, heightened risk of infections, osteoporosis, glaucoma, and cataracts may occur, and dosage should be adjusted gradually. Due to immunosuppressive effects, it may make patients very susceptible to infections such as chickenpox and measles, so attention should be paid to infection prevention, and immediate medical attention should be sought if infections are suspected or arise. In addition, live vaccinations should be avoided during treatment with this drug, as interactions with other medications may increase the risk of side effects or reduce the effectiveness of this drug. During pregnancy, it may affect the fetus, and while breastfeeding, this drug may be transmitted through breast milk, so pregnant or nursing women should carefully consider the use of this medication. In children, side effects such as growth retardation may occur, so it should be administered at the minimum dose while closely monitoring. In the elderly, there is a higher risk of side effects such as infections, diabetes, osteoporosis, and glaucoma, so use should be cautious. When using this medication, it is recommended to follow the doctor’s instructions and use the minimum effective dose for a short duration, and any occurrence of side effects should be reported to the medical professional immediately.

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

This medication should be stored in a tightly closed container to protect it from air and moisture, preferably at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness and prevent deterioration.

Appearance

White round tablets

Package unit

30 tablets/bottle, 300 tablets/bottle