Asolon Tablets (Methylprednisolone)

Adult use

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, although an initial high 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 must be determined individually according to the various diseases being treated and the patient's response. After an adequate response is obtained, 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. The dosage must be continuously monitored. Dose adjustment may be necessary if the disease improves or worsens, if an individual patient’s response to the medication changes, or if the patient is exposed to stressful circumstances that do not directly affect 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 medication. 2. Multiple sclerosis For treatment of acute exacerbations of multiple sclerosis, it is effective to administer prednisolone 200mg daily for 1 week, followed by prednisolone 80mg every other day for 1 month (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 requiring long-term medication 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 restores nearly normal hypothalamus-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 at 6 a.m. The increase in ACTH stimulates adrenal cortical activity, causing plasma cortisol levels to peak between 2 a.m. and 8 a.m. This increase in cortisol reduces ACTH production and thus also reduces adrenal cortical synthesis. During the day, this gradually lowers plasma corticosteroid levels, which reach their minimum around midnight. The 24-hour HPA rhythm is absent in Cushing's disease, a condition characterized by hypercortisolism, 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 they occur, disruption of the diurnal rhythm due to maintenance of elevated corticosteroid levels during the night 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 the suppression of cortisol production by the adrenal cortex. The time required for HPA activity to return to normal 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 prednisolone (10mg) divided into 4 daily doses administered every 6 hours, 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 up to 2 days or longer. Methylprednisolone, hydrocortisone, prednisone, prednisolone, and other corticosteroids are considered short-acting (a single dose causes adrenal cortical suppression for 1¼ to 1½ days) and are therefore suitable 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 who require long-term corticosteroid therapy. 3) For less severe diseases with indications for corticosteroid therapy, ADT may be used initially. 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 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 According to 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) Because of the advantages of ADT, this form of treatment is desirable for patients who have taken corticosteroids every day for a long time (for example, rheumatoid arthritis). These patients may already have HPA axis suppression, so establishing ADT may be difficult and is not always successful. However, regular attempts to switch are recommended. If this is difficult, 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 controlled again, attempts should be made 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 adrenal cortical activity to the least extent. 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 disease progression, it may be necessary to return to a fully suppressive dose of corticosteroids divided throughout the day for control. Once control is achieved, an attempt can be made to resume the established alternate-day regimen. 9) Although many adverse effects of corticosteroid therapy may be minimized with ADT, as with any treatment, the physician must carefully weigh the benefit-risk ratio of treatment for each patient being considered for corticosteroid therapy.

Child use

Growth suppression in children

This medication should not be used in certain patients. For example, it should not be administered to those allergic to this drug or its ingredients, those with unmanageable infections or systemic fungal infections, as well as patients with herpes simplex, shingles, chickenpox, and those receiving live vaccines. Additionally, patients with genetic lactose intolerance should not use this medication. It should be administered cautiously in patients with glaucoma, tuberculosis, cataracts, hypertension, thrombosis, heart diseases, peptic ulcers, mental disorders, osteoporosis, and other conditions, and patients with infections or diabetes should be monitored closely. When using this medication, various side effects such as edema, hypertension, muscle weakness, osteoporosis, gastrointestinal problems, skin changes, neurological symptoms, endocrine abnormalities, and ocular problems may occur, so symptoms should be closely observed. Long-term use can lead to severe issues such as adrenal insufficiency; thus, it should not be abruptly stopped but rather tapered off gradually, and dosage adjusted in cases of trauma, surgery, or infections. Due to its immunosuppressive effects, there is an increased susceptibility to infections, so caution should be exercised to avoid exposure to infectious diseases like chickenpox or measles, and immediate medical attention should be sought if infection is suspected. This medication may interact with various drugs, so it is crucial to consult with a physician or pharmacist if taking other medications, especially when combined with heart-related drugs, anticoagulants, diuretics, and antibiotics. Pregnant or breastfeeding women should use this medication only when absolutely necessary due to potential effects on the fetus or newborn, and breastfeeding should be discontinued during use. When administering to children or elderly patients, caution is needed due to the risk of growth retardation or side effects; minimal doses should be used, with regular monitoring of their condition. Finally, if any abnormal symptoms arise while using this medication, immediate notification of medical personnel is essential for appropriate treatment.

Edema, sodium retention, potassium loss, fluid retention, hypokalemic alkalosis, congestive heart failure, hypertension, myasthenia, avascular necrosis of the femoral and humeral heads, steroid myopathy, muscle wasting, pathological fractures of the pelvis, osteoporosis, spinal compression fractures, arthralgia, tendon rupture, increased ALT, increased AST, increased ALP, nausea, dry mouth, vomiting, abdominal 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, inhibition of skin reactions, purpura, acne, hirsutism, hair loss, pigmentation, increased intracranial pressure, papilledema, seizures, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth retardation in children, symptoms of latent diabetes, secondary adrenal insufficiency, pituitary non-responsiveness, decreased glucose tolerance, increased requirement for insulin or oral hypoglycemic agents, inhibition of adrenocorticotropic hormone secretion, increased intraocular pressure, glaucoma, subcapsular cataracts, 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 reactions, hypersensitivity reactions

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

Appearance

White circular tablets

Package unit

30 tablets/bottle, 300 tablets/bottle