Prisolone Tablets (Methylprednisolone)

Adult use

1. The initial dose 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 achieved. If a satisfactory clinical outcome 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 suitable intervals until the lowest dose that maintains an adequate clinical response is reached. The dose must be monitored continuously. Situations that may require dose adjustment include improvement or worsening of the disease, individual differences in patient response to the drug, and the effect on the patient of exposure 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 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 (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 who require long-term drug therapy 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 allows nearly normal hypothalamic-pituitary-adrenal (HPA) activity to be re-established on the days when corticosteroids are not administered. A brief summary of HPA physiology may help explain this rationale. Free cortisol acts mainly through the hypothalamus; therefore, a decrease in free cortisol stimulates the pituitary gland to increase production of adrenocorticotropic hormone (ACTH), while 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 level stimulates adrenal cortical activity, causing plasma cortisol to peak between 2-8 a.m. This increase in cortisol reduces ACTH production and consequently decreases adrenal cortical synthesis. This progressively lowers plasma corticosteroid levels throughout the day, reaching a minimum around midnight. The 24-hour HPA rhythm is absent in Cushing's disease, a condition characterized by hyperfunction of the adrenal cortex, 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 symptoms of hyperadrenocorticism may typically occur during long-term corticosteroid drug therapy, when doses are divided throughout the day. If they occur, disruption of the diurnal rhythm due to sustained elevated corticosteroid levels overnight may play an important role in the development of corticosteroid adverse effects. Avoiding persistently 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 sensitive to any stressful circumstances. Although a single morning dose causes substantially less adrenal suppression than prednisolone (10mg) taken in 4 divided doses every 6 hours, there is evidence that, at pharmacologic doses, some suppression of adrenal activity persists 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 causes adrenal cortical suppression for 1¼ to 1½ days), and therefore alternate day therapy is recommended. 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 drug therapy. 3) For less severe diseases for which corticosteroid therapy is indicated, ADT may be used initially. For more severe conditions, 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 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 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 level as soon as possible, 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 been taking corticosteroids daily for a long time (for example, rheumatoid arthritis). As these patients may already have HPA axis suppression, establishing ADT may be difficult and is not always successful. However, regular attempts to switch are recommended. If this is difficult, administering 3 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 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) Maximum adrenal cortical activity occurs from 2 a.m. to 8 a.m., and minimum activity from 4 p.m. to midnight. When administered during the period of maximum 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 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 attempted again. 9) Although many adverse effects of corticosteroid therapy may be minimized with ADT, as with any treatment setting, the physician must 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, those who have had allergic reactions to this medication or its ingredients should not use it. Also, this medication should not be given to patients with infections lacking appropriate antimicrobial treatment or systemic fungal infections, as it can suppress immune function and worsen the infections. Patients with herpes simplex, herpes zoster, or chickenpox should also not receive this medication, nor should patients receiving live vaccines or attenuated live vaccines. This medication contains lactose and should not be used in patients with genetic issues such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. There are cases where careful administration is required. For example, glaucoma patients need to be cautious as intraocular pressure may increase, worsening their condition. Patients with tuberculosis, keratitis, posterior capsule cataract, electrolyte imbalance, hypertension, thrombosis, and those who have recently undergone bowel anastomosis may also experience worsening conditions with this medication, and should be used carefully. Patients with infections, diabetes, osteoporosis, renal failure, congestive heart failure, hypothyroidism, fatty liver disease, myasthenia gravis, elderly patients, and those with epilepsy also require special caution. When using this medication, one must carefully observe for side effects. Symptoms such as edema, increased blood pressure, muscle weakness, osteoporosis, gastrointestinal issues, skin changes, and psychiatric symptoms may occur. Furthermore, prolonged use may lead to adrenal insufficiency; therefore, sudden discontinuation should be avoided, and the dosage should be gradually reduced. Due to immunosuppressive action, there may be an increased risk of infections, so special care should be taken to avoid infection with chickenpox or measles. During pregnancy, this medication may affect the fetus, so it should only be carefully administered when necessary, and breast-feeding should be avoided while taking it. In children, side effects such as growth retardation may occur, so the minimum dose should be used and growth should be closely monitored. Elderly patients are at higher risk for side effects such as infections, diabetes, and osteoporosis, so they should be administered this medication with even more caution. This medication may interact with other drugs, so if patients are taking any medications, they must inform their doctor or pharmacist. Particularly, caution is needed when taken concurrently with cardiac medications, antibiotics, diuretics, anticoagulants, and antidiabetic medications.

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 mass loss, pathologic 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, esophagitis, diarrhea, wound healing delay, facial erythema, thin and fragile skin, abnormal sweating, petechial hemorrhage, purpura, skin reaction suppression, purpura, acne, hirsutism, hair loss, pigmentation, increased intracranial pressure, papilledema, seizures, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth suppression, latent diabetes symptoms, adrenal insufficiency, pituitary non-responsiveness, reduced glucose tolerance, increased insulin requirements, suppression of adrenocorticotropic hormone secretion, increased intraocular pressure, glaucoma, posterior capsule opacification, 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 protect it from air and moisture. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius.

Appearance

White oval tablets

Package unit

30 tablets/bottle, 500 tablets/bottle