Mediwon Tablet (Methylprednisolone)

Adult dosage

1. The initial dosage may vary from 4mg to 48mg per day of methylprednisolone, depending on the symptoms of the specific disease. In general, a low dose is sufficient for less severe conditions, but an initial high 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. Continued monitoring of the dose is required. Situations that may require dose adjustment include improvement or worsening of the disease, the individual patient's response to the medication, 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 effect on the patient's condition. After long-term treatment, gradual dose reduction is recommended when discontinuing the medication. 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 increase the effects of corticosteroids in patients who require long-term medication use 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 restores near-normal hypothalamic-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 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 level at 6 a.m. The increase in ACTH stimulates adrenal cortical activity, causing plasma cortisol to peak between 2-8 a.m. This increase in cortisol decreases ACTH production and thus also reduces adrenal cortical synthesis. As a result, plasma corticosteroid levels gradually decrease throughout the day, reaching a minimum around midnight. The 24-hour HPA rhythm is absent in Cushing's disease, a condition characterized by adrenal cortical hyperfunction, with symptoms including 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 may typically occur during long-term corticosteroid therapy administered in divided doses throughout the day. If these manifestations 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 continuously 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) divided into 4 doses every 6 hours throughout the day, there is evidence that, with 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 results in adrenal cortical 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 generally be planned for patients requiring long-term corticosteroid therapy. 3) ADT may be used initially for less severe diseases for which corticosteroid therapy is indicated. In more severe disease, 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 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 is achieved, either of the following approaches may be used. 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 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 the HPA axis may already be suppressed in these patients, it may be difficult to establish ADT, and it is not always successful. However, regular attempts to make the change are recommended. If there is difficulty, administering 3 times, or even 4 times, the daily dose every other day is preferable to simply doubling the daily dose. Once the patient is again controlled, attempt 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 prolonged period (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, 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 is achieved, ADT may be reattempted using the established regimen. 9) Although many adverse effects of corticosteroid therapy may be minimized with ADT, as with any treatment setting, the physician must carefully consider the balance of benefits and risks of treatment for each patient for whom corticosteroid therapy is being considered.

This medication should not be used in certain patients. For instance, individuals allergic to this medication or its components, those with infections resistant to antibiotics or systemic fungal infections, individuals diagnosed with herpes simplex or shingles, those receiving live vaccines, and individuals with genetic issues affecting lactose digestion should not take this medication. Furthermore, this medication should be used cautiously in certain patients. Special care is needed for individuals with glaucoma or tuberculosis, cataracts, electrolyte imbalances, hypertension, thrombosis, recent surgeries, heart diseases, peptic ulcers, psychiatric disorders, osteoporosis, diabetes, diminished renal or thyroid function, liver diseases, elderly patients, and those with epilepsy. There may be various side effects when taking this medication, thus careful observation is necessary. Symptoms such as edema, hypertension, muscle weakness, osteoporosis, gastrointestinal issues, skin changes, neurological symptoms, endocrine disorders, and eye issues may occur. If any of these symptoms manifest, medical consultation should be sought immediately. Long-term use of this medication can lead to adrenal insufficiency; therefore, do not abruptly stop taking it but gradually taper the dose. Additionally, since resistance to infections may be weakened, caution is advised to avoid exposure to chickenpox or measles, and medical evaluation should occur if an infection is suspected. This medication can interact with several other drugs; thus, it is crucial to inform your doctor or pharmacist if you are taking other medications, especially cardiac drugs, antibiotics, diuretics, antidiabetic agents, and anticoagulants. Women who are pregnant or breastfeeding should consult with a doctor before using this medication as it may affect the fetus or newborn. It is recommended to discontinue breastfeeding while taking this medication. In children and adolescents, careful use at the minimum effective dose is recommended, as it may impact growth; prolonged use may also lead to symptoms of increased intracranial pressure. Elderly patients are at a higher risk for side effects such as infections, diabetes, osteoporosis, hypertension, and glaucoma; therefore special caution is required. This medication may reduce the effectiveness of certain vaccines, so care should be taken during vaccinations, and it may also interfere with skin tests or other evaluations. Finally, if any unusual symptoms arise while on this medication, it is important to consult a healthcare professional promptly to receive appropriate care.

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 pelvis, osteoporosis, vertebral compression fractures, arthralgia, tendon rupture, increased ALT, increased AST, increased ALP, nausea, dry mouth, vomiting, gastric pain, anorexia, hyperphagia, peptic ulcer, abdominal distension, pancreatitis, ulcerative esophagitis, diarrhea, delayed wound healing, facial erythema, thin and fragile skin, abnormal sweating, petechiae, purpura, suppression of skin reactions, purpura, acne, hirsutism, hair loss, pigmentation, nipple edema, increased intracranial pressure, convulsions, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual abnormalities, growth suppression in children, symptoms of latent diabetes, secondary adrenal insufficiency, pituitary unresponsiveness, decreased insulin sensitivity, increased demand for insulin or oral hypoglycemic agents, suppression of adrenocorticotropic hormone secretion, increased intraocular pressure, glaucoma, posterior subcapsular cataract, secondary infections of the eye due to fungi or viruses, retinal disorders, exophthalmos, negative nitrogen balance due to protein catabolism, immune system disorders, allergic reactions, shock, urticaria, anaphylactic reaction, hypersensitivity reactions

This medication can be sensitive to air and moisture; therefore, it must be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1 to 30 degrees Celsius at room temperature to ensure the stability of the medication's effects.

Appearance

White round tablet

Package unit

30 tablets/bottle, 500 tablets/bottle