Medication info

Ostem Methylprednisolone Tablets

Prescription medicationTabletOral · Ear dropsExpired
Ingredient · strength
Methylprednisolone›4mg / 1 tablet
Manufacturer / importer
Ostem Pharmaceutical Co., Ltd.
Appearance
White circular tablets
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Expired

MFDS item code 202003399 · Approved 2020.05.11

This product's status changed to Expired on 2025.05.11. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of systemic inflammatory and allergic diseases, endocrine and edematous disorders, and hematologic, neoplastic, and infectious diseases
Who uses it
Adults
Adult dosage
1. The initial dose may vary from 4mg to 48mg of methylprednisolone daily, 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 some 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 should be determined individually according to the disease 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. Continued monitoring of the dose is required. Situations that may require dose adjustment include remission or worsening of the disease, individual patient 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 provide 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 80mg of prednisolone 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. Although a single morning dose produces substantially less adrenal suppression than taking prednisolone (10mg) divided into 4 doses every 6 hours throughout the day, 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. ① Switch to ADT and gradually reduce the amount of corticosteroid given on alternate days. ② Depending on disease control, reduce the daily corticosteroid dose to the minimum effective amount as soon as possible, and then switch to the alternate-day schedule. If this is difficult, it is preferable to administer 3 or even 4 times the daily dose on alternate days rather than only twice the daily dose. Once the patient is controlled again, attempt to reduce this dose to the minimum.

Ingredients

Manufacturer
Ostem Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of systemic inflammatory and allergic diseases, endocrine and edematous disorders, and hematologic, neoplastic, and infectious diseases

  • Endocrine disorders
  • adrenal cortex insufficiency
  • hypercalcemia
  • non-purulent thyroiditis
  • post-traumatic osteoarthritis
  • synovitis of osteoarthritis
  • inflammatory rheumatoid arthritis
  • acute and subacute bursitis
  • epicondylitis
  • acute nonspecific tendinitis
  • acute gouty arthritis
  • psoriatic arthritis
View approved original text

This medication is used for various diseases, first effective for endocrine disorders such as adrenal cortex insufficiency and congenital adrenal hyperplasia. In rheumatic disorders, it helps with short-term treatment of inflammatory diseases such as osteoarthritis, rheumatoid arthritis, and tendinitis. It is also used for the exacerbation of collagen diseases such as systemic lupus erythematosus, polymyositis, and acute rheumatic myocarditis. For skin diseases, it is effective for severe dermatitis such as pemphigus, severe psoriasis, and Stevens-Johnson syndrome. Additionally, it is utilized for anti-inflammatory effects in severe allergic diseases like bronchial asthma and atopic dermatitis, as well as in ocular conditions. It is used in various fields, including gastrointestinal, respiratory, hematological, malignant tumors, edematous diseases, and neurological disorders, for symptom improvement and treatment.

Dosage and Administration

Adult dosage

1. The initial dose may vary from 4mg to 48mg of methylprednisolone daily, 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 some 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 should be determined individually according to the disease 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. Continued monitoring of the dose is required. Situations that may require dose adjustment include remission or worsening of the disease, individual patient 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 provide 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 80mg of prednisolone 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. Although a single morning dose produces substantially less adrenal suppression than taking prednisolone (10mg) divided into 4 doses every 6 hours throughout the day, 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. ① Switch to ADT and gradually reduce the amount of corticosteroid given on alternate days. ② Depending on disease control, reduce the daily corticosteroid dose to the minimum effective amount as soon as possible, and then switch to the alternate-day schedule. If this is difficult, it is preferable to administer 3 or even 4 times the daily dose on alternate days rather than only twice the daily dose. Once the patient is controlled again, attempt to reduce this dose to the minimum.

Precautions

This medication should not be used in patients with allergic reactions or severe infections. It should not be administered to patients with herpes simplex, herpes zoster, or chickenpox, or who are receiving live vaccines. Patients with genetic metabolic disorders such as lactose intolerance should also avoid taking this medication. Patients with specific diseases such as glaucoma, tuberculosis, hypertension, diabetes, osteoporosis must use this medication very cautiously and only if necessary. This medication may cause various side effects such as fluid retention, increased blood pressure, muscle weakness, gastrointestinal issues, skin changes, and neurological disturbances; symptoms must be monitored closely. Prolonged use may lead to adrenal insufficiency, and it should not be abruptly discontinued but rather tapered off gradually. In stressful situations like surgery or infection, the dosage may need to be temporarily increased. As this is a corticosteroid, attention should be paid to avoid exposure to infectious diseases such as chickenpox or measles due to decreased immune resistance. Additionally, as there are many interactions with other medications, patients must inform their healthcare provider of all medications they are taking. Women who are pregnant or breastfeeding should consult a physician before use due to potential effects on the fetus or newborn. In children, growth delays may occur, so the minimum dosage should be used while closely monitoring growth status. Elderly patients should be treated with extra caution due to an increased risk of side effects like infections, osteoporosis, or hypertension.

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 substance loss, pathological fractures of the pelvis, osteoporosis, spinal compression fractures, arthralgia, tendon rupture, increased ALT, increased AST, increased ALP, nausea, thirst, vomiting, abdominal pain, loss of appetite, increased appetite, peptic ulcers, 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, hair loss, pigmentation, increased intracranial pressure, papilledema, convulsions, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth suppression, latent diabetes symptoms, adrenal insufficiency, non-responsive pituitary, impaired glucose tolerance, increased insulin requirements, suppression of adrenocorticotropic hormone secretion, increased intraocular pressure, glaucoma, posterior capsule cataract, secondary infections, retinal disorders, proptosis, nitrogen equilibrium, 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 sealed container to protect it from air and moisture. The optimal storage temperature is between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White circular tablets

Package unit

30 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.