Methylprednisolone Tablets (Methylprednisolone)

Adult use

The initial dose 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 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 obtained after a reasonable period, treatment should be discontinued and another appropriate treatment initiated. The dose should 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 appropriate intervals until the lowest dose that maintains an adequate clinical response is reached. Continuous monitoring of the dose is required. Dose adjustment may be necessary in situations such as improvement or worsening of the disease, individual patient response to the medication, or the effect on the patient of exposure to stressful circumstances that have no direct effect on the symptoms of the disease being treated. In the latter case, it may be necessary to increase the dose for a period sufficient to satisfactorily manage the patient’s condition. After long-term treatment, gradual dose reduction is recommended when discontinuing the medication. Multiple sclerosis Treatment of acute exacerbations of multiple sclerosis is effective with prednisolone 200mg daily for 1 week, followed by prednisolone 80mg every other day for 1 month (4mg of methylprednisolone is equivalent to 5mg of prednisolone). 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 suppression of the pituitary-adrenal axis, 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 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 at 6 a.m. The increased ACTH levels stimulate adrenal cortical activity, causing plasma cortisol to peak between 2-8 a.m. This increase in cortisol reduces ACTH production and therefore decreases adrenal cortical synthesis. This causes plasma corticosteroids to gradually decrease throughout the day, reaching a minimum level at midnight. The 24-hour HPA rhythm is absent in Cushing's disease, a condition of adrenal cortical hyperfunction characterized by obesity with central fat distribution, thin skin that bruises easily, weakness and muscle wasting, hypertension, latent diabetes, osteoporosis, and electrolyte imbalance. The clinical manifestations of the same 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 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 typical pharmacologic-dose corticosteroid therapy, 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, there is evidence that, when pharmacologic doses are used, some suppression of 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 recommended for alternate-day therapy. The following 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. 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 options are possible. ① Switch to ADT and gradually reduce the amount of corticosteroid administered every other day. ② Reduce the daily corticosteroid dose to the minimum effective dose as soon as possible, according to control of disease progression, and then switch to an alternate-day schedule. Theoretically, option ① is more desirable. 4) Because of the advantages of ADT, this form of treatment 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 ADT may be difficult and is not always successful. However, regular attempts to make the change are recommended. If difficulties arise, 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, 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 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 corticosteroid dose divided throughout the day to achieve control. Once control is achieved, the established alternate-day regimen may be attempted again. 9) Although many adverse effects of corticosteroid therapy may be minimized with ADT, as in any treatment setting, the physician must carefully weigh 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, it should not be administered to those allergic to this drug or its components, or those with infections where effective antimicrobial agents are lacking, or systemic fungal infections, as infection may worsen. Additionally, patients with herpes simplex, shingles, chickenpox, or those receiving live vaccines should not use this medication. This drug contains lactose and should not be given to patients with lactose intolerance or certain genetic conditions. Some patients require careful administration. For example, patients with glaucoma, tuberculosis, cataracts, electrolyte imbalances, hypertension, thrombosis, recent surgeries, etc., may experience worsening symptoms with this medication, so special caution is necessary. Furthermore, diabetic patients, patients with renal failure, congestive heart failure, and hypothyroid patients should be closely monitored, as their conditions may worsen with administration. Various side effects may occur while using this medication, including edema, hypertension, muscle weakness, osteoporosis, gastrointestinal issues, skin changes, psychiatric symptoms, endocrine disturbances, and ocular problems. Long-term use can particularly lead to adrenal suppression or acute adrenal failure, so the dosage should be gradually reduced according to the physician's guidance, as abrupt discontinuation is risky. Moreover, this medication suppresses immune function, making patients more susceptible to infections. Caution is advised to avoid exposure to infections like chickenpox or measles, and if an infection is suspected, immediate medical attention should be sought. When used with other medications, many interactions may occur; therefore, patients should inform their healthcare provider about any other medications they are taking, as some combinations can increase the risk of side effects or reduce effectiveness. Women who are pregnant or may become pregnant should use this medication cautiously, as it could affect the fetus, and must consult with a physician. If breastfeeding, it is recommended to discontinue nursing as this medication can be transmitted through breast milk. When administered to children, side effects such as growth retardation may occur, so the minimum effective dose should be used and growth should be carefully monitored. In elderly patients, the risk of side effects is higher, so such patients should be administered the drug with greater caution and their condition should be frequently checked. Patients should strictly follow their doctor's instructions when using this medication and report any side effects or unusual symptoms to medical personnel immediately.

Edema, sodium retention, potassium loss, fluid retention, hypokalemic alkalosis, congestive heart failure, hypertension, myasthenia, avascular necrosis of the femoral and humeral epiphysis, steroid myopathy, muscle wasting, pathologic fractures of the iliac bone, osteoporosis, spinal compression fractures, arthralgia, tendon rupture, elevated ALT, elevated AST, elevated ALP, nausea, thirst, 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, hair loss, hyperpigmentation, increased intracranial pressure, papilledema, convulsions, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth suppression in children, signs of latent diabetes mellitus, secondary adrenal insufficiency, pituitary apoplexy, decreased glucose tolerance, increased demand for insulin or oral hypoglycemic agents, suppression of adrenocorticotropic hormone secretion, increased intraocular pressure, glaucoma, posterior capsule 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 reactions, hypersensitivity reactions

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain storage temperatures between 1°C and 30°C room temperature. Proper storage helps preserve the effectiveness and safety of the medication.

Appearance

White round tablets

Package unit

30 tablets/bottle, 300 tablets/bottle