Medication info
Methylone 1mg Tablet (Methylprednisolone)

Methylone 1mg Tablet (Methylprednisolone)

Prescription medicationTablet
Ingredient · strength
Methylprednisolone Micronized›1mg / 1 tablet
Manufacturer / importer
Alvogen Korea Co., Ltd.
Appearance
White round tablet
Packaging
300 tablets/bottle
Approval status
Active

MFDS item code 201309384 · Approved 2013.09.17 · Insurance code 652603260

Summary

Main use
Treatment of inflammatory and allergic diseases, endocrine, blood, and neoplastic diseases, and edema, neurologic, and infectious diseases
Who uses it
Adults
Adult dosage
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, although 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 achieved after a reasonable period, treatment should be discontinued and another appropriate therapy initiated. The dose must be determined individually according to the various diseases being treated and the patient's response. After an adequate response is achieved, the 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 patient responsiveness to the drug, and the effects 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 satisfactory control of 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 every 2 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 persist longer than their physical presence and metabolic effects, and 2) Taking corticosteroids in the morning every other day allows near-normal hypothalamic-pituitary-adrenal (HPA) activity to be re-established on the days when corticosteroids are not administered. A brief review 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 adrenocorticotropic hormone (ACTH) production, 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. Increased ACTH levels stimulate adrenal cortical activity, causing plasma cortisol to peak between 2 and 8 a.m. This increase in cortisol reduces ACTH production and thus also decreases adrenal cortical synthesis. As a result, plasma corticosteroid levels gradually decline throughout the day, reaching their lowest level around midnight. The 24-hour HPA rhythm is absent in Cushing's disease, a condition of hyperadrenocorticism characterized by 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 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 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 four 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, even a single dose of any corticosteroid has been shown to suppress the adrenal cortex for 2 days or more. Other corticosteroids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered short-acting (a single dose causes adrenal cortical suppression for 1¼ to 1½ days); therefore, alternate day therapy is recommended. The following points should be kept in mind when using alternate day therapy. 1) The fundamental 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 from the outset for less severe diseases for which corticosteroid therapy is indicated. For more serious diseases, divided-dose therapy with high 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 approaches are possible. ① Switch to ADT and gradually reduce the amount of corticosteroid given on alternate days. ② Reduce the daily corticosteroid dose to the minimum effective level as soon as possible, according to control of disease progression, and 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 taken 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. Nevertheless, regular attempts to make the change are recommended. If this is difficult, it is preferable to administer 3 times or even 4 times the daily dose on alternate days 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 prolonged period (for example, dexamethasone, betamethasone). 6) Adrenal cortical activity is greatest from 2 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, when using ADT it is important to provide individualized and appropriate treatment for each patient. 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 dose of corticosteroids in divided doses throughout the day for control. Once control has been 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 ratio of benefits to risks of treatment for each patient being considered for corticosteroid therapy.

Ingredients

Manufacturer
Alvogen Korea Co., Ltd.

Efficacy & effects

Treatment of inflammatory and allergic diseases, endocrine, blood, and neoplastic diseases, and edema, neurologic, and infectious diseases

  • Endocrine disorders
  • adrenal cortical insufficiency
  • hypercalcemia
  • non-suppurative thyroiditis
  • post-traumatic osteoarthritis
  • synovitis in osteoarthritis
  • juvenile rheumatoid arthritis
  • acute and subacute bursitis
  • epicondylitis
  • acute nonspecific tendinitis
  • acute gouty arthritis
  • psoriatic arthritis
View approved original text

This medication is effectively used for a variety of conditions. Firstly, it is used for endocrine disorders including primary and secondary adrenal cortical insufficiency, congenital adrenal hyperplasia, and hypercalcemia associated with cancer. For rheumatic disorders, it helps with various inflammatory joint diseases such as acute osteoarthritis, rheumatoid arthritis, acute and subacute bursitis, and psoriatic arthritis. It is also utilized in the treatment of exacerbations of collagen diseases such as systemic lupus erythematosus and dermatomyositis. In terms of skin diseases, it improves severe inflammatory conditions such as pemphigus, severe psoriasis, and severe seborrheic dermatitis. This medication is used for a wide range of disease groups including allergic diseases, ophthalmic diseases, gastrointestinal disorders, respiratory diseases, blood disorders, malignant tumors, edematous conditions, and neurological diseases, effectively alleviating and treating patient symptoms. This medication is widely used for the improvement and treatment of symptoms in multiple diseases.

Dosage and Administration

Adult dosage

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, although 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 achieved after a reasonable period, treatment should be discontinued and another appropriate therapy initiated. The dose must be determined individually according to the various diseases being treated and the patient's response. After an adequate response is achieved, the 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 patient responsiveness to the drug, and the effects 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 satisfactory control of 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 every 2 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 persist longer than their physical presence and metabolic effects, and 2) Taking corticosteroids in the morning every other day allows near-normal hypothalamic-pituitary-adrenal (HPA) activity to be re-established on the days when corticosteroids are not administered. A brief review 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 adrenocorticotropic hormone (ACTH) production, 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. Increased ACTH levels stimulate adrenal cortical activity, causing plasma cortisol to peak between 2 and 8 a.m. This increase in cortisol reduces ACTH production and thus also decreases adrenal cortical synthesis. As a result, plasma corticosteroid levels gradually decline throughout the day, reaching their lowest level around midnight. The 24-hour HPA rhythm is absent in Cushing's disease, a condition of hyperadrenocorticism characterized by 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 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 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 four 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, even a single dose of any corticosteroid has been shown to suppress the adrenal cortex for 2 days or more. Other corticosteroids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered short-acting (a single dose causes adrenal cortical suppression for 1¼ to 1½ days); therefore, alternate day therapy is recommended. The following points should be kept in mind when using alternate day therapy. 1) The fundamental 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 from the outset for less severe diseases for which corticosteroid therapy is indicated. For more serious diseases, divided-dose therapy with high 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 approaches are possible. ① Switch to ADT and gradually reduce the amount of corticosteroid given on alternate days. ② Reduce the daily corticosteroid dose to the minimum effective level as soon as possible, according to control of disease progression, and 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 taken 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. Nevertheless, regular attempts to make the change are recommended. If this is difficult, it is preferable to administer 3 times or even 4 times the daily dose on alternate days 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 prolonged period (for example, dexamethasone, betamethasone). 6) Adrenal cortical activity is greatest from 2 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, when using ADT it is important to provide individualized and appropriate treatment for each patient. 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 dose of corticosteroids in divided doses throughout the day for control. Once control has been 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 ratio of benefits to risks of treatment for each patient being considered for corticosteroid therapy.

Precautions

This medication should not be used in specific patients. For example, patients with allergies to this medication or its components, those with infections, and those receiving live vaccines should not take this medication. Additionally, patients with specific conditions such as glaucoma, tuberculosis, hypertension, or thrombosis should use this medication with increased caution. In these cases, it should be administered carefully and only when necessary in consultation with a physician. While taking this medication, various side effects such as edema, muscle weakness, gastrointestinal issues, skin changes, and psychological symptoms may occur, so symptoms should be closely monitored. If any abnormal symptoms arise, medical personnel should be notified immediately. Prolonged use of this medication can lead to adrenal insufficiency; therefore, it should not be suddenly discontinued, but rather gradually tapered off. The dosage may need to be adjusted in stressful situations such as surgery or infections. This medication has numerous interactions with other drugs; hence, if a patient is taking other medications, they must inform their physician or pharmacist, especially when used alongside heart medications, antihypertensives, anticoagulants, or antibiotics. Women who are pregnant or may become pregnant should discuss with a physician before using this medication, as it may affect the fetus, and breastfeeding should be discontinued if nursing. In pediatric or elderly patients, due to the risks of growth delay or side effects, it should be administered at the minimum effective dose with careful monitoring, particularly during prolonged use. Lastly, precautions should be taken to avoid exposure to infectious diseases such as chickenpox or measles while taking this medication, and medical attention should be sought immediately if an infection is suspected.

Side effects

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, pathological fractures of the pelvis, osteoporosis, vertebral 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 distention, 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, pigmentation, increased intracranial pressure, papilledema, convulsions, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth suppression in children, 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 of the eye due to fungi or viruses, retinal disorders, proptosis, negative nitrogen balance due to protein catabolism, immune system disorders, allergic reactions, shock, urticaria, anaphylactic reactions, hypersensitivity reactions

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to maintain the storage temperature between 1 to 30 degrees Celsius at room temperature. This storage method helps to preserve the medication's efficacy and safety over a longer period.

Appearance and packaging

Appearance

White round tablet

Package unit

300 tablets/bottle

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.