Megamesolon 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. A low dose is generally 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 a satisfactory clinical result is 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. Situations that may require dosage adjustment include improvement or worsening of the disease, individual patient response to the drug, and the effect on the patient of exposure to stressful circumstances 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 achieve a satisfactory response in the patient’s 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 treatment 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 two 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 almost normal hypothalamic-pituitary-adrenal (HPA) activity to be restored on days when corticosteroids are not administered. A brief overview 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 increase in ACTH levels stimulates adrenocortical activity, causing plasma cortisol to peak between 2 a.m. and 8 a.m. This increase in cortisol reduces ACTH production and consequently decreases adrenocortical synthesis. This causes plasma corticosteroid levels to 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 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 manifestations of hyperadrenocorticism can typically occur during long-term corticosteroid therapy administered in divided doses throughout the day. If they occur, disruption of the circadian rhythm due to maintenance of elevated corticosteroid levels overnight may 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 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, some suppression of adrenal activity continues into the following day. In addition, adrenal cortical suppression has been observed for 2 days or longer after a single dose of any corticosteroid. Other corticosteroids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered short-acting (adrenocortical suppression occurs for 1¼ to 1½ days after a single dose) 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 approach for patients requiring long-term corticosteroid treatment. 3) ADT may be used initially for less severe diseases for which corticosteroid therapy is indicated. For 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, 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, and then change to an alternate-day schedule. Theoretically, approach ① is preferable. 4) Given the advantages of ADT, this form of treatment is desirable for patients who have been taking corticosteroids daily for a long period (for example, rheumatoid arthritis). Because 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 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 merely 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, 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 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, it is important to provide individualized and appropriate treatment for each patient when using ADT. Complete control of symptoms is not possible for 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 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, 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 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, if the patient has an allergy to this drug or its components, has an unresolvable infectious disease, or has viral infections such as herpes simplex, herpes zoster, or chickenpox. Furthermore, patients receiving live vaccines or having genetic lactose-related issues should also avoid this medication. This drug should be used with caution in patients with specific diseases such as glaucoma, tuberculosis, cataracts, hypertension, thrombosis, peptic ulcer, psychosis, and osteoporosis. Especially, individuals with various health conditions such as infections, diabetes, renal failure, hypothyroidism, fatty liver, myasthenia gravis, the elderly, epilepsy, ulcerative colitis should take this drug cautiously under medical guidance. This medication can cause multiple side effects, so symptoms should be closely monitored. Edema, increased blood pressure, muscle weakness, osteoporosis, gastrointestinal issues, skin changes, mental and neurological abnormalities, endocrine problems, and eye abnormalities may occur. Especially with long-term use, adrenal insufficiency or withdrawal symptoms may arise, so it should not be suddenly discontinued but rather gradually reduced. While taking this medication, the risk of infections may increase, so care should be taken to avoid exposure to infectious diseases such as chickenpox or measles, and if infection is suspected, medical attention should be sought immediately. Moreover, live vaccination should be avoided during treatment with this drug. This drug may interact with other medications, so especially when taken with heart-related medications, antibiotics, diuretics, anticoagulants, blood sugar-lowering agents, the patient should inform their doctor or pharmacist and use caution. The dosage may need to be adjusted as the drug's effectiveness may decrease, or side effects may increase. Pregnant women or those who may become pregnant should only use this medication if the benefits outweigh the risks to the fetus, and nursing mothers are advised to avoid taking it. In children, side effects such as growth delay or increased intracranial pressure may occur, so the minimum effective dose should be used and the patient should be carefully monitored. The elderly also face a higher risk of side effects like infections, diabetes, osteoporosis, and glaucoma, so careful management is crucial. During treatment with this medication, it is important to undergo regular check-ups and blood tests under medical supervision to ensure safe management.

Edema, sodium retention, potassium loss, fluid retention, hypokalemic alkalosis, congestive heart failure, hypertension, myasthenia, aseptic necrosis of the femoral and humeral heads, steroid myopathy, muscle wasting, pathological fractures of the pelvis, osteoporosis, vertebral compression fractures, arthralgia, tendon rupture, increased ALT, increased AST, increased ALP, nausea, dry mouth, vomiting, abdominal 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, suppression of skin reactions, purpura, acne, hirsutism, alopecia, pigmentation, papilledema, increased intracranial pressure, convulsions, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth suppression, 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 subcapsular cataract, secondary infections, retinal disorder, exophthalmos, negative nitrogen balance, immune system disorders, allergic reactions, shock, urticaria, anaphylactic reactions, hypersensitivity reactions

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is best stored at room temperature, between 1 to 30 degrees Celsius.

Appearance

White round tablet

Package unit

30 tablets/bottle, 500 tablets/bottle