Medication info
Methylon Tablet (Methylprednisolone)

Methylon Tablet (Methylprednisolone)

Prescription medicationTablet
Ingredient · strength
Methylprednisolone Micronized›4mg / 1 tablet
Manufacturer / importer
Albozen Korea Co., Ltd.
Appearance
White circular tablet
Packaging
30 tablets/bottle, 100 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 199701131 · Notified 1997.09.22 · Insurance code 652600730

Summary

Main use
Treatment of inflammatory, allergic, endocrine, hematologic, and edematous conditions, as well as neoplastic, neurologic, and infectious diseases
Who uses it
Adults
Adult dosage
1. The initial dosage may vary from 4mg to 48mg per day as methylprednisolone, depending on the symptoms of the specific disease. In general, a low dose is 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 obtained. If a satisfactory clinical result is not achieved after a reasonable period, discontinue administration and switch to another appropriate treatment. The dosage should be determined individually according to the various diseases being treated and the patient's response. After an adequate response has been 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 dosage must be monitored continuously. Situations that may require dose adjustment include remission or worsening of the disease, individual differences in the patient's response to the drug, and the effect on the patient of exposure to stressful circumstances that are not directly related to 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 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 every other day. The purpose of this regimen is to enhance the effects of corticosteroids in patients requiring long-term drug treatment, while minimizing adverse effects such as suppression of the pituitary-adrenal axis, a 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 almost normal hypothalamic-pituitary-adrenal (HPA) activity to be reestablished on the days when corticosteroids are not administered. A brief review of HPA physiology may help explain this rationale. Free cortisol acts mainly 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 to peak between 2 a.m. and 8 a.m. This increase in cortisol reduces ACTH production and consequently lowers adrenal cortical synthesis. As a result, plasma corticosteroid levels gradually decrease during the day, reaching a minimum around midnight. The 24-hour HPA rhythm is absent in Cushing's disease, a condition characterized by hyperadrenocorticism 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 when the medication is divided into doses throughout the day. If they occur, disruption of the diurnal rhythm due to maintenance of elevated corticosteroid levels during the night is likely to 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 to recover 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 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 must 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 treatment. 3) ADT may be used initially for less severe diseases for which corticosteroid therapy is indicated. 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 has been achieved, either of the following approaches may be used. ① Switch to ADT and gradually reduce the amount of corticosteroid given every other day. ② Reduce the daily corticosteroid dose to the minimum effective level as quickly as possible, according to control of disease progression, and then switch to an alternate-day schedule. Theoretically, approach ① is more desirable. 4) Given 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 an ADT regimen may be difficult and is not always successful. However, regular attempts to switch are recommended. If this proves 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, certain 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 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 all patients. 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 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 weigh the benefits and risks of treatment for each patient being considered for corticosteroid therapy.

Ingredients

Manufacturer
Albozen Korea Co., Ltd.

Efficacy & effects

Treatment of inflammatory, allergic, endocrine, hematologic, and edematous conditions, as well as neoplastic, neurologic, and infectious diseases

  • Endocrine disorders
  • adrenal cortical insufficiency
  • hypercalcemia
  • non-suppurative thyroiditis
  • osteoarthritis
  • synovitis
  • rheumatoid arthritis
  • bursitis
  • epicondylitis
  • tendinitis
  • gouty arthritis
  • psoriatic arthritis
View approved original text

This medication is used for various endocrine disorders, rheumatic diseases, collagen vascular diseases, skin diseases, allergic diseases, ocular diseases, gastrointestinal disorders, respiratory diseases, hematological disorders, malignant neoplasms, edematous diseases, neurological disorders, and other conditions such as tuberculous meningitis and hypereosinophilia. For example, it is effective in the treatment of adrenal cortical insufficiency, rheumatoid arthritis, systemic lupus erythematosus, severe allergic disorders, pemphigus, bronchial asthma, ulcerative colitis, acquired hemolytic anemia, acute leukemia, idiopathic nephrotic syndrome, and the acute exacerbation of multiple sclerosis. It is widely used as a medication that controls complex inflammation and immune responses, thereby improving symptoms and preventing disease progression.

Dosage and Administration

Adult dosage

1. The initial dosage may vary from 4mg to 48mg per day as methylprednisolone, depending on the symptoms of the specific disease. In general, a low dose is 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 obtained. If a satisfactory clinical result is not achieved after a reasonable period, discontinue administration and switch to another appropriate treatment. The dosage should be determined individually according to the various diseases being treated and the patient's response. After an adequate response has been 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 dosage must be monitored continuously. Situations that may require dose adjustment include remission or worsening of the disease, individual differences in the patient's response to the drug, and the effect on the patient of exposure to stressful circumstances that are not directly related to 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 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 every other day. The purpose of this regimen is to enhance the effects of corticosteroids in patients requiring long-term drug treatment, while minimizing adverse effects such as suppression of the pituitary-adrenal axis, a 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 almost normal hypothalamic-pituitary-adrenal (HPA) activity to be reestablished on the days when corticosteroids are not administered. A brief review of HPA physiology may help explain this rationale. Free cortisol acts mainly 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 to peak between 2 a.m. and 8 a.m. This increase in cortisol reduces ACTH production and consequently lowers adrenal cortical synthesis. As a result, plasma corticosteroid levels gradually decrease during the day, reaching a minimum around midnight. The 24-hour HPA rhythm is absent in Cushing's disease, a condition characterized by hyperadrenocorticism 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 when the medication is divided into doses throughout the day. If they occur, disruption of the diurnal rhythm due to maintenance of elevated corticosteroid levels during the night is likely to 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 to recover 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 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 must 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 treatment. 3) ADT may be used initially for less severe diseases for which corticosteroid therapy is indicated. 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 has been achieved, either of the following approaches may be used. ① Switch to ADT and gradually reduce the amount of corticosteroid given every other day. ② Reduce the daily corticosteroid dose to the minimum effective level as quickly as possible, according to control of disease progression, and then switch to an alternate-day schedule. Theoretically, approach ① is more desirable. 4) Given 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 an ADT regimen may be difficult and is not always successful. However, regular attempts to switch are recommended. If this proves 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, certain 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 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 all patients. 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 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 weigh the benefits and risks of treatment for each patient being considered for corticosteroid therapy.

Precautions

This medication should not be used in patients with allergies to this drug or its components. It should not be administered to patients with infections or systemic fungal infections as it may suppress immune function and worsen the infection. It should also be avoided in patients with viral infections such as herpes simplex, herpes zoster, and chickenpox. It is safest not to use this medication in patients receiving live vaccines or attenuated live vaccines. Additionally, this medication contains lactose, so patients with lactose intolerance or metabolic disorders should not take it. This medication should be used with caution in patients with specific diseases. For example, patients with glaucoma may experience increased intraocular pressure, and those with tuberculosis or herpetic keratitis may be at risk for worsening symptoms. Patients with posterior capsule cataracts, electrolyte disturbances, hypertension, thrombosis, and those who have recently undergone surgery also require caution. Diabetic patients should carefully manage their blood sugar levels as this medication may increase blood glucose. Osteoporosis, renal insufficiency, congestive heart failure, hypothyroidism, fatty liver, and severe myasthenia gravis patients should also exercise caution when using this medication. Elderly patients, patients with epilepsy, and those with a history of peptic ulcers or mental illness require careful monitoring. Due to the potential for various side effects, symptoms should be closely monitored. Electrolyte imbalances such as fluid retention, edema, hypertension, and hypokalemia may occur. Muscle weakness, osteoporosis, arthralgia, thinning of the skin, and delayed wound healing may also occur. Gastrointestinal issues such as nausea, vomiting, changes in appetite, and peptic ulcers have been reported. Central nervous system side effects may include headache, dizziness, insomnia, and depression. Endocrine system side effects include Cushing's syndrome, growth suppression, and worsening diabetes. It can affect the eyes, leading to conditions such as glaucoma or cataracts and changes in vision, so regular check-ups are necessary. Prolonged use may lead to adrenal insufficiency, so it should not be suddenly stopped but rather tapered off gradually. Immunity to infections may decrease, so precautions against infection should be taken, especially to avoid exposure to chickenpox or measles. Patients with active tuberculosis should be administered this medication with appropriate treatment, and latent tuberculosis patients should be regularly monitored. Women who are pregnant or may become pregnant should consult a physician before taking this medication, as it may affect the fetus. If breastfeeding, it is advisable to discontinue nursing, as this medication may pass into breast milk. In children, growth retardation may occur, so the minimum effective dose should be used and growth monitored closely. Caution is necessary when administering this medication to elderly patients due to the higher risk of side effects such as infections, osteoporosis, and diabetes. This medication is known to have many drug interactions, so if other medications are being taken, healthcare providers must be informed. Particular caution is needed when combined with medications that affect cardiac rhythm, anticoagulants, hypoglycemic agents, diuretics, antibiotics, and antifungal agents. In summary, this medication should not be administered to patients with specific diseases or conditions or should be used with caution. Patients should be well aware of the side effects and interactions and follow healthcare professionals' instructions when taking this medication.

Side effects

Edema, sodium retention, potassium loss, fluid retention, hypokalemic alkaline blood syndrome, congestive heart failure, hypertension, myasthenia, avascular necrosis of the femoral and humeral heads, steroid myopathy, muscle wastage, pathological fractures of the pelvis, osteoporosis, vertebral compression fractures, arthralgia, tendon rupture, increased ALT, increased AST, increased ALP, nausea, dry mouth, vomiting, stomach pain, anorexia, hyperphagia, peptic ulcer, abdominal distension, pancreatitis, esophagitis, diarrhea, delayed wound healing, facial erythema, thin and delicate skin, abnormal sweating, petechiae, purpura, suppression phenomenon of skin reactions, purpura, acne, hirsutism, hair loss, pigmentation, papilledema, increased intracranial pressure, convulsions, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth suppression in children, signs of latent diabetes, secondary adrenal insufficiency, pituitary unresponsiveness, decreased glucose tolerance, increased requirement for insulin or oral hypoglycemic agents, suppression of adrenocorticotropic hormone secretion, increased intraocular pressure, glaucoma, posterior capsule cataract, secondary infections of the eye, retinal disorders, proptosis, negative nitrogen balance due to protein catabolism, immune system dysfunction, allergic reactions, shock, urticaria, anaphylactic reactions, hypersensitivity reactions

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is also best to store it at a moderate room temperature, avoiding excessively hot or cold places.

Appearance and packaging

Appearance

White circular tablet

Package unit

30 tablets/bottle, 100 tablets/bottle, 500 tablets/bottle

Same-ingredient medicines

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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.