Dogeon Methylprednisolone Tablet

Adult use

1. The initial dosage may vary from 4mg to 48mg of methylprednisolone per day, depending on the symptoms of the specific disease. A low dose is generally 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 obtained. If a satisfactory clinical outcome is not achieved after a reasonable period, treatment should be discontinued and another appropriate therapy initiated. The dosage should be determined individually according to the disease 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 dosage is required. Circumstances that may require dosage adjustment include remission or worsening of the disease, individual patient response to the medication, and the effect on the patient of exposure to stressful situations that are not directly related to the symptoms of the disease being treated. In the latter case, it may be necessary to increase the dosage for as long as required to achieve satisfactory control of 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 (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 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 two 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 hypothalamic-pituitary-adrenal (HPA) activity on the days when corticosteroids are not administered. A brief overview 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. Increased ACTH levels stimulate adrenal cortical activity, resulting in peak plasma cortisol levels 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 during the day, reaching a minimum around midnight. The 24-hour HPA rhythm is absent in Cushing's disease, a condition characterized by symptoms of adrenal cortical hyperfunction, 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 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 sustained 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 typical pharmacologic-dose corticosteroid therapy, ACTH production is suppressed along with 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 susceptible to any stressful situation. Although a single morning dose causes considerably less adrenal suppression than prednisolone (10mg) administered in 4 divided doses every 6 hours, there is evidence that even slight suppression of adrenal activity from pharmacologic doses continues into the following day. In addition, suppression of the adrenal cortex has been observed after a single dose of any corticosteroid, lasting for 2 days or longer. Other corticosteroids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered short-acting (a single dose produces 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 that are indicated for corticosteroid therapy, ADT may be used initially. For more severe diseases, a regimen of high doses in divided doses during 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 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 lowest effective level as soon as possible, depending on 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 therapy is desirable for patients who have been taking 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 make the change are recommended. If there is difficulty, 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 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 greatest 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 individualize treatment appropriately 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 they are not taking corticosteroids. 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 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 with 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 administered to certain patients. For example, it should not be used in individuals with known allergies to this drug or its components, patients with infections without anti-infectives, and those with systemic fungal infections, as it may worsen the infection. Additionally, it is contraindicated in patients with herpes simplex, herpes zoster, varicella, or those receiving live vaccines. This medication contains lactose, and patients with lactose intolerance or related genetic disorders should avoid using it. Caution is advised in patients with certain conditions, such as glaucoma, tuberculosis, cataracts, hypertension, thromboembolism, and heart disease, as their symptoms may worsen. Such patients should be carefully administered the medication only when necessary. Furthermore, patients with various health conditions such as diabetes, osteoporosis, renal failure, hypothyroidism, fatty liver, myasthenia gravis, the elderly, and those with epilepsy also require careful monitoring. During the use of this medication, multiple side effects may occur, such as edema, elevated blood pressure, muscle weakness, osteoporosis, gastrointestinal disturbances, skin changes, psychological symptoms, endocrine abnormalities, and increased intraocular pressure; thus, symptoms should be closely observed. If used for long periods, adrenal insufficiency may develop; abrupt cessation can pose risks, so dosage should be gradually reduced, and doses may need to be increased during stress situations like infections or surgeries. This drug can suppress immune function, increasing the risk of infections; therefore, exposure to chickenpox or measles should be avoided. If exposed to either, medical consultation should be sought immediately for necessary preventive measures. There may be interactions with multiple medications, so patients taking other drugs should inform their healthcare providers, and dosage adjustments may be necessary. Women who are pregnant or breastfeeding should consult a physician before use, as it may affect the fetus or newborn. In children, growth retardation may occur, so the minimum effective dosage should be employed, and growth status must be carefully monitored. The elderly have an increased risk of side effects related to infections, diabetes, osteoporosis, and glaucoma, necessitating cautious administration and close monitoring of their condition.

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 atrophy, pathologic fractures of the pelvic bones, osteoporosis, vertebral compression fractures, arthralgia, tendon rupture, increased ALT, increased AST, increased ALP, nausea, thirst, vomiting, abdominal pain, loss of appetite, increased appetite, peptic ulcer, abdominal distension, pancreatitis, esophagitis, diarrhea, delayed wound healing, facial erythema, thin and fragile skin, abnormal sweating, petechiae, purpura, suppression of skin reactions, purpura, acne, hirsutism, alopecia, hyperpigmentation, papilledema, increased intracranial pressure, convulsions, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth suppression in children, symptoms of latent diabetes mellitus, 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 eye infections, retinal disorders, exophthalmos, nitrogen balance, immune system disorders, allergic reactions, shock, urticaria, anaphylactic reaction, hypersensitivity reactions

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is crucial to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage helps preserve the drug's efficacy and safety for an extended period.

Appearance

White round tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 300 tablets/bottle