Medication info
Medisoll Tablet (Methylprednisolone)

Medisoll Tablet (Methylprednisolone)

Prescription medicationTablet
Ingredient · strength
Methylprednisolone›4mg / 1 tablet
Manufacturer / importer
Hanol Bio Pharma Co., Ltd.
Appearance
White oval tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201307227 · Approved 2013.05.07 · Insurance code 655604460

Summary

Main use
Treatment of inflammatory and immune diseases; endocrine, hematologic, and edematous disorders; and neoplastic and infectious diseases
Who uses it
Adults
Adult dosage
The initial dose 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 achieved. If a satisfactory clinical result is not obtained after a reasonable period, discontinue treatment and switch to another appropriate therapy. The dose must be individualized according to the various diseases being treated and the patient's response. After an adequate response is achieved, determine an appropriate maintenance dose 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. Dose adjustment may be necessary if the disease improves or worsens, if the patient's response to the medicine varies, or if the patient is exposed to stressors unrelated 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 satisfactorily manage the patient's condition. After long-term treatment, gradual reduction of the dose is recommended when discontinuing the medicine. For treatment of acute exacerbations of multiple sclerosis, administration of prednisolone 200mg daily for 1 week followed by 80mg of prednisolone every other day for 1 month is effective (4mg of methylprednisolone is equivalent to 5mg of prednisolone). Alternate-day therapy means administering twice the daily dose in the morning on one of every 2 days. Although a single morning dose causes substantially less adrenal suppression than taking prednisolone (10mg) in 4 divided doses every 6 hours throughout the day, 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. Methylprednisolone, hydrocortisone, prednisone, prednisolone, and other corticosteroids are considered short-acting (a single dose suppresses the adrenal cortex for 1¼ to 1½ days), and therefore alternate-day therapy is recommended. For less severe diseases for which corticosteroid therapy is indicated, ADT may be used initially. For more severe diseases, divided daily doses of high-dose therapy will usually be required initially to achieve control of disease progression. The initial suppressive dose should be continued until a satisfactory clinical response is achieved, usually for 4 to 10 days for many allergic and collagen diseases. It is important to keep the initial suppressive-dose period as short as possible, particularly if continued use of alternate-day therapy is intended. Once control is achieved, there are two options. 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 preferable. If difficulties arise, 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, attempt to reduce this dose to the minimum. 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. If an acute exacerbation occurs during the course of the disease, it may be necessary to return to fully suppressive divided daily doses of corticosteroids to achieve control. Once control is achieved, the established alternate-day regimen may be attempted again.

Ingredients

Manufacturer
Hanol Bio Pharma Co., Ltd.

Efficacy & effects

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

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

This medication is used to treat endocrine disorders such as adrenal cortical insufficiency, congenital adrenal hyperplasia, and hypercalcemia associated with cancer. It is also effective in relieving symptoms and preventing acute exacerbation of various types of arthritis and inflammatory disorders associated with rheumatic diseases. It is utilized in the treatment of autoimmune diseases like systemic lupus erythematosus and dermatomyositis. It also helps alleviate inflammatory and allergic reactions due to allergic diseases, severe skin diseases, and ophthalmic conditions. It is used for palliative management of gastrointestinal, respiratory, hematological disorders, and malignant neoplasms, as well as for acute exacerbations of neurological disorders. It is widely used for the treatment and symptom improvement of various diseases.

Dosage and Administration

Adult dosage

The initial dose 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 achieved. If a satisfactory clinical result is not obtained after a reasonable period, discontinue treatment and switch to another appropriate therapy. The dose must be individualized according to the various diseases being treated and the patient's response. After an adequate response is achieved, determine an appropriate maintenance dose 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. Dose adjustment may be necessary if the disease improves or worsens, if the patient's response to the medicine varies, or if the patient is exposed to stressors unrelated 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 satisfactorily manage the patient's condition. After long-term treatment, gradual reduction of the dose is recommended when discontinuing the medicine. For treatment of acute exacerbations of multiple sclerosis, administration of prednisolone 200mg daily for 1 week followed by 80mg of prednisolone every other day for 1 month is effective (4mg of methylprednisolone is equivalent to 5mg of prednisolone). Alternate-day therapy means administering twice the daily dose in the morning on one of every 2 days. Although a single morning dose causes substantially less adrenal suppression than taking prednisolone (10mg) in 4 divided doses every 6 hours throughout the day, 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. Methylprednisolone, hydrocortisone, prednisone, prednisolone, and other corticosteroids are considered short-acting (a single dose suppresses the adrenal cortex for 1¼ to 1½ days), and therefore alternate-day therapy is recommended. For less severe diseases for which corticosteroid therapy is indicated, ADT may be used initially. For more severe diseases, divided daily doses of high-dose therapy will usually be required initially to achieve control of disease progression. The initial suppressive dose should be continued until a satisfactory clinical response is achieved, usually for 4 to 10 days for many allergic and collagen diseases. It is important to keep the initial suppressive-dose period as short as possible, particularly if continued use of alternate-day therapy is intended. Once control is achieved, there are two options. 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 preferable. If difficulties arise, 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, attempt to reduce this dose to the minimum. 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. If an acute exacerbation occurs during the course of the disease, it may be necessary to return to fully suppressive divided daily doses of corticosteroids to achieve control. Once control is achieved, the established alternate-day regimen may be attempted again.

Precautions

This medication should not be administered to certain patients. For example, those with allergies to this medication or its components, patients with untreatable infections or systemic fungal infections should not use this medication, as it may exacerbate infections. In addition, it should not be given to patients with herpes simplex, shingles, chickenpox, or those receiving live vaccines, nor to patients with lactose intolerance or related genetic diseases. This medication should be used cautiously in some patients. For example, patients with glaucoma, tuberculosis, keratitis, cataracts, electrolyte disorders, hypertension, thrombosis, recent bowel surgery, a history of myocardial infarction, peptic ulcer, psychosis, or severe osteoporosis may experience worsening symptoms, and caution should be exercised. Patients with infections or diabetes, renal failure, hypothyroidism, fatty liver, severe myasthenia gravis, elderly individuals, epilepsy, ulcerative colitis, and those with a history of relevant conditions should also be administered with caution, as symptoms may worsen in these patients. Side effects may include fluid retention, edema, increased blood pressure, muscle weakness, osteoporosis, gastrointestinal disturbances, skin changes, neurological and endocrine disorders, and eye-related issues, so symptoms should be closely monitored. Long-term use of this medication may lead to decreased adrenal function; therefore, sudden discontinuation may result in various symptoms. The dosage should be gradually reduced, and during stressful situations such as surgery or infection, the dosage may need to be temporarily increased. Due to immune suppression effects, the risk of infection may increase, so caution should be taken to avoid exposure to chickenpox or measles, and vaccination should be avoided during treatment. Interactions are common with other medications, so consultation with a physician or pharmacist is required, especially when used with heart-related medications, antibiotics, diuretics, hypoglycemic agents, anticoagulants, etc. Pregnant or breastfeeding women should only use this medication if necessary due to potential effects on the fetus or newborn, and breastfeeding is recommended to be discontinued. In children, there may be side effects such as growth delays, so the minimum dosage should be used, and growth status should be monitored closely. Elderly patients have a higher risk of side effects, so careful monitoring of infections, diabetes, osteoporosis, glaucoma, etc., is essential while administering this medication cautiously. During the use of this medication, special caution should be observed against infection from chickenpox or measles, and if infection is suspected or occurs, immediate consultation with healthcare providers for appropriate treatment is required.

Side effects

Edema, sodium retention, potassium loss, fluid retention, hypokalemic alkalosis, congestive heart failure, hypertension, myasthenia, aseptic necrosis of the femoral and humeral epiphyses, steroid myopathy, muscle tissue loss, pathological fractures of the iliac bone, osteoporosis, spinal compression fractures, arthralgia, tendon rupture, increased ALT, increased AST, increased ALP, nausea, thirst, vomiting, gastralgia, anorexia, hyperphagia, peptic ulcer, abdominal distension, pancreatitis, ulcerative esophagitis, diarrhea, delayed wound healing, facial erythema, thin and fragile skin, abnormal sweating, petechiae, ecchymosis, skin reaction suppression, purpura, acne, hirsutism, alopecia, hyperpigmentation, papilloedema, increased intracranial pressure, seizures, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth suppression in children, symptoms of latent diabetes mellitus, 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 subcapsular cataract, secondary eye infections, 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 is sensitive to air and moisture; thus, it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to effectively preserve the medication's efficacy and ensure its safe use.

Appearance and packaging

Appearance

White oval tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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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.