Medication info
Mepsoled 4mg (Methylprednisolone)

Mepsoled 4mg (Methylprednisolone)

Prescription medicationTabletEar drops
Ingredient · strength
Methylprednisolone Micronized›4mg / 1 tablet
Manufacturer / importer
Eden Pharma Co., Ltd.
Appearance
White round tablet
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 201601608 · Approved 2016.03.24 · Insurance code 628900680

Summary

Main use
Treatment of inflammatory and allergic disorders, endocrine, blood, and neoplastic disorders, and neurological, edema, and infectious diseases
Who applies the ear drops
Adults
Adult use
1. The initial dose may vary from 4 mg to 48 mg of methylprednisolone per day, 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 treatment and switch to another appropriate therapy. The dose should be individualized according to the various diseases being treated and the patient's response. After an adequate response is obtained, 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. Situations that may require dose adjustment include remission or exacerbation of the disease, an individual patient's response to the medicine, and the effect on the patient of exposure to stressful circumstances unrelated to the symptoms of the disease being treated. In the latter situation, it may be necessary to increase the dose for a period sufficient to achieve a satisfactory response in the patient's condition. After long-term treatment, gradual dose reduction is recommended when discontinuing the medicine. 2. Multiple sclerosis Treatment of acute exacerbations of multiple sclerosis is effective with prednisolone 200 mg daily for 1 week, followed by prednisolone 80 mg every other day for 1 month (methylprednisolone 4 mg is equivalent to prednisolone 5 mg). 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 considerably less adrenal suppression than taking prednisolone (10 mg) in 4 divided doses every 6 hours throughout the day, there is evidence that, when pharmacologic doses are used, some suppressive effect on adrenal activity continues into the following day. 3) The fundamental principles and indications of corticosteroid therapy should be applied. The advantages of ADT should not encourage indiscriminate use of corticosteroids. 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 As disease progression comes under control, reduce the daily corticosteroid dose to the minimum effective dose as soon as possible, then change to an alternate-day schedule. 4) If this is difficult, it is preferable to administer 3 or even 4 times the daily dose on alternate days rather than merely doubling the daily dose. Once the patient is controlled again, attempt to reduce this dose to the lowest level. 8) If an acute exacerbation occurs during disease progression, it may be necessary to return to a fully suppressive corticosteroid dose divided throughout the day to achieve control. Once control is achieved, the established alternate-day regimen may be tried again.

Ingredients

Manufacturer
Eden Pharma Co., Ltd.

Efficacy & effects

Treatment of inflammatory and allergic disorders, endocrine, blood, and neoplastic disorders, and neurological, edema, and infectious diseases

  • Endocrine disorders
  • adrenal cortical insufficiency
  • hypercalcemia
  • non-purulent thyroiditis
  • rheumatic disorders
  • post-traumatic osteoarthritis
  • synovitis of osteoarthritis
  • inflammatory rheumatoid arthritis
  • bursitis
  • epicondylitis
  • non-specific tendinitis
  • gouty arthritis
View approved original text

This medication is used for various diseases. Firstly, it is employed for endocrine disorders, including primary and secondary adrenal cortical insufficiency, congenital adrenal hyperplasia, and hypercalcemia accompanying cancer. Furthermore, it is effective for rheumatic disorders such as post-traumatic osteoarthritis, synovitis of osteoarthritis, rheumatoid arthritis, acute and subacute bursitis, acute gouty arthritis, and ankylosing spondylitis. It is also utilized in the treatment of connective tissue diseases like systemic lupus erythematosus, dermatomyositis, and acute rheumatic myocarditis. For dermatological diseases, it is used in conditions like pemphigus, severe erythema multiforme, exfoliative dermatitis, and severe psoriasis, as well as in allergic disorders including bronchial asthma, atopic dermatitis, and allergic rhinitis. Moreover, it is used in the treatment of ophthalmic disorders, gastrointestinal diseases, respiratory diseases, blood disorders, malignant tumors, edema diseases, neurological diseases, and various other illnesses.

How to apply ear drops

Adult use

1. The initial dose may vary from 4 mg to 48 mg of methylprednisolone per day, 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 treatment and switch to another appropriate therapy. The dose should be individualized according to the various diseases being treated and the patient's response. After an adequate response is obtained, 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. Situations that may require dose adjustment include remission or exacerbation of the disease, an individual patient's response to the medicine, and the effect on the patient of exposure to stressful circumstances unrelated to the symptoms of the disease being treated. In the latter situation, it may be necessary to increase the dose for a period sufficient to achieve a satisfactory response in the patient's condition. After long-term treatment, gradual dose reduction is recommended when discontinuing the medicine. 2. Multiple sclerosis Treatment of acute exacerbations of multiple sclerosis is effective with prednisolone 200 mg daily for 1 week, followed by prednisolone 80 mg every other day for 1 month (methylprednisolone 4 mg is equivalent to prednisolone 5 mg). 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 considerably less adrenal suppression than taking prednisolone (10 mg) in 4 divided doses every 6 hours throughout the day, there is evidence that, when pharmacologic doses are used, some suppressive effect on adrenal activity continues into the following day. 3) The fundamental principles and indications of corticosteroid therapy should be applied. The advantages of ADT should not encourage indiscriminate use of corticosteroids. 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 As disease progression comes under control, reduce the daily corticosteroid dose to the minimum effective dose as soon as possible, then change to an alternate-day schedule. 4) If this is difficult, it is preferable to administer 3 or even 4 times the daily dose on alternate days rather than merely doubling the daily dose. Once the patient is controlled again, attempt to reduce this dose to the lowest level. 8) If an acute exacerbation occurs during disease progression, it may be necessary to return to a fully suppressive corticosteroid dose divided throughout the day to achieve control. Once control is achieved, the established alternate-day regimen may be tried again.

Precautions

This medication should not be administered to individuals who are allergic to specific components or who have hypersensitivity reactions. Caution is advised when there is an infection, especially if there are infections that are resistant to antibiotics or systemic fungal infections, as this medication can suppress immune function and worsen the infection. It should not be given to patients with viral infections such as herpes simplex, shingles, and chickenpox, nor to patients receiving live vaccines or attenuated live vaccines. This medication contains lactose, so patients with lactose intolerance or related genetic diseases should avoid it. Patients with glaucoma, tuberculosis, keratitis, cataracts, electrolyte imbalances, hypertension, thrombosis, or recent bowel anastomosis should use this medication cautiously as they may have an increased risk of symptom exacerbation. Patients with diabetes, osteoporosis, kidney failure, heart failure, hypothyroidism, fatty liver, myasthenia gravis, elderly patients, and those with epilepsy should also be cautious when administered. Various side effects can occur with this drug, such as fluid and electrolyte imbalances, muscle and bone issues, gastrointestinal symptoms, skin changes, neurological and psychiatric symptoms, endocrine imbalances, and eye-related problems, so symptoms should be carefully monitored. Long-term use can suppress adrenal function, making abrupt discontinuation dangerous; thus, doses should be gradually reduced, and dosages should be temporarily increased in stressful situations. Due to immune-suppressive effects, there is an increased vulnerability to infections, which can be fatal, especially if exposed to diseases like chickenpox or measles, so checking vaccination history and medical history is crucial. There are many interactions with other medications that can increase the risk of side effects, necessitating consultation with a physician or pharmacist. Women who are pregnant or breastfeeding should only use this medication if absolutely necessary, and breastfeeding should be discontinued if used. In children, side effects like growth retardation can occur, so it is necessary to use the minimum dose and carefully monitor growth status. Elderly patients have a higher risk of side effects such as infections, diabetes, osteoporosis, and glaucoma, so they should be administered this medication with caution. During the course of this medication, problems such as hypokalemia, reduced vaccine effectiveness, and suppressed skin reactions can occur; therefore, regular check-ups and care are necessary.

Side effects

Edema, sodium retention, potassium loss, fluid retention, hypokalemic alkalosis, congestive heart failure, hypertension, myasthenia, aseptic necrosis of the femur and humerus, steroid myopathy, muscle wasting, pathological fractures of the pelvis, osteoporosis, spinal compression fractures, arthralgia, tendon rupture, increased ALT, increased AST, increased ALP, nausea, thirst, vomiting, stomach pain, loss of appetite, increased appetite, peptic ulcer, abdominal bloating, pancreatitis, 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, papilledema, increased intracranial pressure, seizures, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth suppression in children, latent diabetes symptoms, secondary adrenal insufficiency, pituitary unresponsiveness, reduced insulin sensitivity, increased requirement for insulin or oral hypoglycemic agents, suppression of adrenocorticotropic hormone secretion, increased intraocular pressure, glaucoma, posterior subcapsular cataract, secondary eye infections due to fungi or viruses, central serous chorioretinopathy, retinal disorders, exophthalmos, 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 may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is advisable to keep the storage temperature between 1 and 30 degrees Celsius to safely maintain the medication's efficacy.

Appearance and packaging

Appearance

White round tablet

Package unit

30 tablets/bottle, 500 tablets/bottle

Same-ingredient medicines

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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.