Medication info
Mefna Tablet (Methylprednisolone)

Mefna Tablet (Methylprednisolone)

Prescription medicationTablet
Ingredient · strength
Methylprednisolone›4mg / 1 tablet
Manufacturer / importer
Hubist Pharmaceutical Co., Ltd.
Appearance
White oval-shaped tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201403627 · Approved 2014.08.05 · Insurance code 628800020

Summary

Main use
Treatment of systemic diseases (such as inflammatory and allergic conditions), endocrine disorders, and hematologic and neoplastic diseases
Who uses it
Adults
Adult dosage
The initial dosage 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, 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 result is not obtained after a reasonable period, discontinue administration and switch to another appropriate treatment. The dose should be determined individually according to the disease 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 dosage is required. Situations that may require dosage adjustment include relief or worsening of the disease, individual patient responsiveness 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. 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). 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 therapy 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 allows near-normal restoration of hypothalamic-pituitary-adrenal (HPA) activity on the days corticosteroids are not administered. A brief review of HPA physiology may help clarify this rationale. Free cortisol acts primarily 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. Increased ACTH levels stimulate adrenal cortical activity, causing plasma cortisol to peak between 2 a.m. and 8 a.m. This increase in cortisol decreases ACTH production and consequently reduces adrenal cortical synthesis. As a result, plasma corticosteroid levels gradually decrease throughout 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 continuously elevated plasma concentrations, even for short periods, 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 with the dose and duration of treatment. During this period, the patient is susceptible 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 throughout the day, there is evidence that, at pharmacologic doses, 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. Methylprednisolone, hydrocortisone, prednisone, prednisolone, and other corticosteroids 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 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. In 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 when 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 According to control of disease progression, reduce the daily corticosteroid dose to the minimum effective dose as soon as possible, and then switch to an alternate-day schedule. Theoretically, 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). 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, attempts should be made to reduce this dose to the minimum. 5) As noted above, some corticosteroids suppress adrenal function for a prolonged period and are therefore not recommended for alternate-day therapy (for example, dexamethasone and 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 in 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 corticosteroid dose divided throughout the day to achieve control. Once control has been 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 should carefully weigh the ratio of benefits to risks of treatment for each patient being considered for corticosteroid therapy.

Ingredients

Manufacturer
Hubist Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of systemic diseases (such as inflammatory and allergic conditions), endocrine disorders, and hematologic and neoplastic diseases

  • Endocrine disorders
  • adrenal cortical insufficiency
  • hypercalcemia
  • non-suppurative thyroiditis
  • post-traumatic osteoarthritis
  • synovitis of osteoarthritis
  • inflammatory rheumatism
  • acute and subacute bursitis
  • epicondylitis
  • acute non-specific tendinitis
  • acute gouty arthritis
  • psoriatic arthritis
View approved original text

This medication is used for various conditions. It is indicated for endocrine disorders such as adrenal cortical insufficiency, congenital adrenal hyperplasia, and hypercalcemia associated with cancer. It is also used for rheumatic disorders such as osteoarthritis, rheumatoid arthritis, and psoriatic arthritis. It is effective for collagen diseases such as systemic lupus erythematosus, skin diseases such as pemphigus and severe psoriasis, and for allergic conditions like bronchial asthma and atopic dermatitis. Additionally, it is used in ophthalmic conditions, gastrointestinal diseases, respiratory diseases, hematological diseases, malignant neoplastic diseases, edematous diseases, and neurological diseases. Overall, it is employed in the treatment of various inflammatory and immune-related disorders.

Dosage and Administration

Adult dosage

The initial dosage 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, 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 result is not obtained after a reasonable period, discontinue administration and switch to another appropriate treatment. The dose should be determined individually according to the disease 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 dosage is required. Situations that may require dosage adjustment include relief or worsening of the disease, individual patient responsiveness 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. 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). 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 therapy 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 allows near-normal restoration of hypothalamic-pituitary-adrenal (HPA) activity on the days corticosteroids are not administered. A brief review of HPA physiology may help clarify this rationale. Free cortisol acts primarily 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. Increased ACTH levels stimulate adrenal cortical activity, causing plasma cortisol to peak between 2 a.m. and 8 a.m. This increase in cortisol decreases ACTH production and consequently reduces adrenal cortical synthesis. As a result, plasma corticosteroid levels gradually decrease throughout 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 continuously elevated plasma concentrations, even for short periods, 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 with the dose and duration of treatment. During this period, the patient is susceptible 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 throughout the day, there is evidence that, at pharmacologic doses, 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. Methylprednisolone, hydrocortisone, prednisone, prednisolone, and other corticosteroids 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 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. In 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 when 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 According to control of disease progression, reduce the daily corticosteroid dose to the minimum effective dose as soon as possible, and then switch to an alternate-day schedule. Theoretically, 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). 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, attempts should be made to reduce this dose to the minimum. 5) As noted above, some corticosteroids suppress adrenal function for a prolonged period and are therefore not recommended for alternate-day therapy (for example, dexamethasone and 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 in 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 corticosteroid dose divided throughout the day to achieve control. Once control has been 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 should carefully weigh the ratio of benefits to risks of treatment for each patient being considered for corticosteroid therapy.

Precautions

This medication should not be used in certain patients. For example, it should not be given to patients who are allergic to this medication or its ingredients, those with infections lacking effective antimicrobial therapy, or those with systemic fungal infections as it may worsen the infection. It should also not be used in patients with herpes simplex, herpes zoster, chickenpox, or those receiving live vaccines. This medication contains lactose, so it should not be given to patients with lactose intolerance. Patients who require careful monitoring include those with glaucoma, tuberculous diseases, posterior capsule cataracts, electrolyte abnormalities, hypertension, thrombosis, and those who recently underwent bowel anastomosis, as they must be particularly cautious when using this medication. Patients with diabetes or osteoporosis, renal failure, or congestive heart failure may experience an exacerbation of symptoms due to this medication, hence caution is necessary. Patients with psychiatric disorders, older adults, epilepsy, or peptic ulcer may also worsen with this medication, necessitating careful observation. Adverse effects may include edema, sodium retention, potassium loss, hypertension, muscle weakness, aseptic necrosis of the femoral and humeral heads, steroid myopathy, loss of muscle mass, pathological fractures of the iliac bone, osteoporosis, spinal compression fractures, joint pain, tendon rupture, increased ALT, increased AST, increased ALP, nausea, thirst, vomiting, abdominal pain, loss of appetite, increased appetite, abdominal bloating, pancreatitis, ulcers. Furthermore, increased intraocular pressure may lead to glaucoma or cataracts, and the immunosuppressive effect may increase the risk of infections, endocrine dysfunction, and allergic reactions, thus symptoms should be closely monitored. Long-term use of this medication may lead to adrenal insufficiency, and abrupt discontinuation is dangerous; instead, a gradual tapering should be performed. In stressful situations such as infections, surgeries, or trauma, the dose may need to be temporarily increased. Due to the immunosuppressive effect, caution should be taken to avoid exposure to infections such as chickenpox or measles, and vaccination is also restricted. This medication may interact with various drugs; patients taking other medications must inform their physician or pharmacist, especially when combined with cardiac medications, anticoagulants, antihyperglycemics, or diuretics. During pregnancy, it should be used only when necessary as it may affect the fetus, and during breastfeeding, it is advisable to discontinue nursing since it may pass into breast milk. In children, there may be growth retardation, so it should be used cautiously at the minimum effective dose, and older adults are also at increased risk of side effects, thus careful monitoring is necessary. While taking this medication, infections like chickenpox or measles can be fatal, so patients should verify their medical history and vaccination status, and seek immediate medical attention if infection is suspected.

Side effects

Edema, sodium retention, potassium loss, fluid retention, hypokalemic alkalosis, congestive heart failure, hypertension, myasthenia, avascular necrosis of the femoral and humeral heads, steroid myopathy, muscle wasting, pathological fractures of the pelvis, osteoporosis, vertebral compression fractures, arthralgia, tendon rupture, increased ALT, increased AST, increased ALP, nausea, thirst, vomiting, abdominal pain, loss of appetite, 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, alopecia, pigmentation, papilledema, increased intracranial pressure, seizures, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth inhibition in children, symptoms of latent diabetes mellitus, secondary adrenal insufficiency, pituitary unresponsiveness, decreased insulin sensitivity, increased requirements for insulin or oral hypoglycemic agents, suppression of adrenocorticotropic hormone secretion, increased intraocular pressure, glaucoma, posterior capsule cataract, secondary infection of the eye, retinal disorders, proptosis, negative nitrogen balance due to 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 may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is recommended to maintain a storage temperature between 1°C and 30°C. This way, the effectiveness of the medication can be preserved for a longer period.

Appearance and packaging

Appearance

White oval-shaped tablet

Package unit

30 tablets/bottle, 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.