Medication info
Methyl Tablet (Methylprednisolone)

Methyl Tablet (Methylprednisolone)

Prescription medicationTablet
Ingredient · strength
Methylprednisolone›4mg / 1 tablet
Manufacturer / importer
Kips Biopharma Co., Ltd.
Appearance
White oval tablets
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 201404339 · Approved 2014.09.24 · Insurance code 693201070

Summary

Main use
Treatment of inflammatory and immune diseases, endocrine, hematologic, and edematous disorders, and 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. A low dose is generally sufficient for conditions that are not severe, 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 result is not obtained after a reasonable period, discontinue administration and switch to another appropriate treatment. The dose must 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. Continuous monitoring of the dose is required. Circumstances that may require dose adjustment include remission or worsening of the disease, individual patient response to the medication, 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 satisfactorily manage 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 (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 other day. The purpose of this regimen is to enhance the effects of corticosteroids in patients requiring long-term medication, while minimizing 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 restores nearly normal hypothalamus-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 mainly through the hypothalamus; therefore, 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 reach a peak between 2-8 a.m. This increase in cortisol reduces ACTH production and therefore also 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 symptoms 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 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 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 prednisolone (10mg) taken 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 causes adrenal cortical suppression for 1¼ to 1½ days) and therefore are 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 requiring long-term corticosteroid therapy. 3) For less severe diseases for which corticosteroid therapy is indicated, ADT may be used initially. For more severe diseases, a regimen of high doses administered in divided doses throughout the day will usually be required to initially control 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 ongoing 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 given every other day. 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. Theoretically, option ① is more desirable. 4) Because of the advantages of ADT, this form of therapy is desirable for patients who have taken corticosteroids daily for a long time (for example, rheumatoid arthritis). As the HPA axis may already be suppressed in these patients, establishing an ADT regimen may be difficult and may not always be successful. However, 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 every other day rather than merely doubling the daily dose. Once the patient is again controlled, 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) 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 highest 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 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 administered in divided doses 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 consider the ratio of benefits to risks of treatment for each patient for whom corticosteroid therapy is being considered.

Ingredients

Manufacturer
Kips Biopharma Co., Ltd.

Efficacy & effects

Treatment of inflammatory and immune diseases, endocrine, hematologic, and edematous disorders, and neoplastic, neurologic, and infectious diseases

  • Endocrine disorders
  • adrenal cortical insufficiency
  • congenital adrenal hyperplasia
  • hypercalcemia
  • non-suppurative thyroiditis
  • post-traumatic osteoarthritis
  • synovitis of osteoarthritis
  • erosive rheumatic arthritis
  • acute and subacute bursitis
  • epicondylitis
  • acute nonspecific tendinitis
  • acute gouty arthritis
View approved original text

This medication is used for a variety of conditions. It is effective for endocrine disorders such as primary and secondary adrenal cortical insufficiency, congenital adrenal hyperplasia, and hypercalcemia. For rheumatic disorders, it helps alleviate symptoms of acute progressive arthritis, osteoarthritis, and ankylosing spondylitis. It is also used for collagen diseases like systemic lupus erythematosus, dermatomyositis, and rheumatic heart disease. Furthermore, it is applied in the treatment of severe skin diseases, severe allergic conditions, ophthalmic disorders, gastrointestinal and respiratory diseases, hematological disorders, malignant neoplastic diseases, edematous conditions, and neurological disorders. This drug is used to improve symptoms of various complex diseases with its comprehensive effects.

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. A low dose is generally sufficient for conditions that are not severe, 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 result is not obtained after a reasonable period, discontinue administration and switch to another appropriate treatment. The dose must 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. Continuous monitoring of the dose is required. Circumstances that may require dose adjustment include remission or worsening of the disease, individual patient response to the medication, 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 satisfactorily manage 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 (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 other day. The purpose of this regimen is to enhance the effects of corticosteroids in patients requiring long-term medication, while minimizing 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 restores nearly normal hypothalamus-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 mainly through the hypothalamus; therefore, 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 reach a peak between 2-8 a.m. This increase in cortisol reduces ACTH production and therefore also 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 symptoms 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 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 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 prednisolone (10mg) taken 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 causes adrenal cortical suppression for 1¼ to 1½ days) and therefore are 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 requiring long-term corticosteroid therapy. 3) For less severe diseases for which corticosteroid therapy is indicated, ADT may be used initially. For more severe diseases, a regimen of high doses administered in divided doses throughout the day will usually be required to initially control 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 ongoing 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 given every other day. 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. Theoretically, option ① is more desirable. 4) Because of the advantages of ADT, this form of therapy is desirable for patients who have taken corticosteroids daily for a long time (for example, rheumatoid arthritis). As the HPA axis may already be suppressed in these patients, establishing an ADT regimen may be difficult and may not always be successful. However, 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 every other day rather than merely doubling the daily dose. Once the patient is again controlled, 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) 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 highest 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 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 administered in divided doses 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 consider the ratio of benefits to risks of treatment for each patient for whom corticosteroid therapy is being considered.

Precautions

This medication should not be administered to specific patients. For instance, it should not be used in patients who are allergic to this drug or any of its ingredients, those with infections without proper antibiotics, or those with systemic fungal infections, herpes simplex, shingles, or chickenpox. Additionally, patients receiving live vaccines or with genetic issues such as lactose intolerance should also not be treated with this medication. Patients requiring cautious administration include those with glaucoma, tuberculosis, cataract, electrolyte imbalances, hypertension, thrombosis, and recent bowel anastomosis, as their conditions may worsen when using this drug. This medication suppresses immune function, which may worsen infections, so it should be used cautiously in patients with existing infections or in those with diabetes, osteoporosis, renal failure, hypothyroidism, fatty liver, and older adults. Potential side effects include edema, hypertension, muscle weakness, osteoporosis, gastrointestinal issues, skin changes, neuropsychiatric symptoms, endocrine disorders, and visual abnormalities; if these symptoms occur, the patient should consult a healthcare professional immediately. Long-term use may lead to adrenal insufficiency, so the dosage should not be abruptly stopped but gradually reduced, and the dosage may need to be increased during stressful situations like surgery or infections. This drug can interact with other medications, so patients should inform their healthcare providers of any other medications they are taking, particularly when using heart-related drugs, antibiotics, diuretics, and antidiabetic agents. Pregnant or breastfeeding women should use this medication only if absolutely necessary and should discontinue breastfeeding. In children, growth retardation may occur, so the minimum dose should be used, and growth status should be closely monitored. Older adults are at increased risk for side effects such as infections, diabetes, osteoporosis, hypertension, and glaucoma, and should be administered this medication cautiously. Finally, during treatment with this drug, being infected with chickenpox or measles can be very dangerous; thus, it is essential to verify past medical history and vaccination status and take special care to prevent infections.

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, loss of muscle mass, pathological fracture of the pelvis, osteoporosis, spinal compression fracture, arthralgia, tendon rupture, increased ALT, increased AST, increased ALP, nausea, thirst, vomiting, gastralgia, reduced appetite, increased appetite, peptic ulcer, abdominal distension, pancreatitis, ulcerative esophagitis, diarrhea, delayed wound healing, facial erythema, thin and fragile skin, unusual sweating, petechiae, purpura, skin reaction suppression, purpura, acne, hypertrichosis, hair loss, pigmentation, papilledema, increased intracranial pressure, seizures, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth suppression, latent diabetes symptoms, adrenal insufficiency, pituitary unresponsiveness, decreased glucose tolerance, increased demand for insulin or oral hypoglycemics, suppression of adrenocorticotropic hormone secretion, increased intraocular pressure, glaucoma, posterior subcapsular cataract, secondary infection, retinal disorder, exophthalmos, negative nitrogen balance, immune system disorder, allergic reaction, shock, urticaria, anaphylactic reaction, hypersensitivity reaction

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering and kept at room temperature between 1 and 30 degrees Celsius. Storing it this way will help to maintain the efficacy of the drug over time.

Appearance and packaging

Appearance

White oval tablets

Package unit

30 tablets/bottle, 500 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.