Medication info
Predwin Tablet (Methylprednisolone)

Predwin Tablet (Methylprednisolone)

Prescription medicationTabletEar drops
Ingredient · strength
Methylprednisolone›4mg / 1 tablet
Manufacturer / importer
Ilsung IS Co., Ltd.
Appearance
White round tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201804425 · Approved 2018.11.07 · Insurance code 655404240

Summary

Main use
Treatment of inflammatory and immune diseases, endocrine, hematologic and edematous disorders, and neoplastic and infectious diseases
Who applies the ear drops
Adults
Adult use
The initial dose may vary from 4mg to 48mg per day of methylprednisolone, depending on the symptoms of the specific disease. After an adequate response has been 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. After long-term treatment, gradual dose reduction is recommended when discontinuing the drug. 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 (4mg of methylprednisolone is equivalent to 5mg of prednisolone). Alternate-day therapy means administering twice the daily dose on one morning every other day. Although a single morning dose causes considerably less adrenal suppression than taking prednisolone (10mg) in 4 divided doses every 6 hours, there is evidence that, when pharmacological doses are used, a slight suppressive effect on adrenal activity continues into the following day. Other corticosteroids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered short-acting (a single dose causes adrenocortical suppression for 1¼ to 1½ days); therefore, alternate-day therapy is recommended. 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. Switch to ADT and gradually reduce the amount of corticosteroid given on alternate days. As disease progression is controlled, reduce the daily corticosteroid dose to the minimum effective dose as soon as possible, and then switch to an alternate-day schedule. If difficulties arise, administering 3 or even 4 times the daily dose every other day is preferable to simply doubling the daily dose. If an acute exacerbation occurs during disease progression, it may be necessary to return to a fully suppressive dose of corticosteroid divided throughout the day to achieve control.

Ingredients

Manufacturer
Ilsung IS Co., Ltd.

Efficacy & effects

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

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

This medication is used for various diseases. It is effective for endocrine disorders such as adrenal cortex insufficiency and congenital adrenal hyperplasia, as well as hypercalcemia associated with cancer. Additionally, it alleviates acute exacerbations of inflammatory diseases such as osteoarthritis, rheumatoid arthritis, and gouty arthritis. It helps treat collagen diseases like systemic lupus erythematosus and dermatomyositis, as well as acute rheumatic myocarditis. It is also used for skin diseases such as pemphigus, severe psoriasis, and Stevens-Johnson syndrome, and improves allergic disorders including bronchial asthma, atopic dermatitis, and allergic rhinitis. This medication is also used in the treatment of ophthalmic diseases, gastrointestinal diseases, respiratory diseases, blood diseases, malignant tumors, edematous diseases, neurological diseases, and tuberculous meningitis. In summary, this drug is used for a variety of diseases including endocrine, rheumatic, collagen, skin, allergic, ophthalmic, gastrointestinal, respiratory, blood, tumors, and neurological issues.

How to apply ear drops

Adult use

The initial dose may vary from 4mg to 48mg per day of methylprednisolone, depending on the symptoms of the specific disease. After an adequate response has been 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. After long-term treatment, gradual dose reduction is recommended when discontinuing the drug. 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 (4mg of methylprednisolone is equivalent to 5mg of prednisolone). Alternate-day therapy means administering twice the daily dose on one morning every other day. Although a single morning dose causes considerably less adrenal suppression than taking prednisolone (10mg) in 4 divided doses every 6 hours, there is evidence that, when pharmacological doses are used, a slight suppressive effect on adrenal activity continues into the following day. Other corticosteroids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered short-acting (a single dose causes adrenocortical suppression for 1¼ to 1½ days); therefore, alternate-day therapy is recommended. 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. Switch to ADT and gradually reduce the amount of corticosteroid given on alternate days. As disease progression is controlled, reduce the daily corticosteroid dose to the minimum effective dose as soon as possible, and then switch to an alternate-day schedule. If difficulties arise, administering 3 or even 4 times the daily dose every other day is preferable to simply doubling the daily dose. If an acute exacerbation occurs during disease progression, it may be necessary to return to a fully suppressive dose of corticosteroid divided throughout the day to achieve control.

Precautions

This medication should not be administered to certain patients. For example, those allergic to this medication or its components should not use it. Additionally, it should not be administered to patients with infections lacking effective antimicrobial agents or those with systemic fungal infections as it may worsen the infection. Patients with herpes simplex, herpes zoster, and chickenpox should also avoid this medication, as well as those receiving live vaccines or live attenuated vaccines. This medication contains lactose, so patients with genetic galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take it. This medication should be administered cautiously in some patients. Those with glaucoma may experience worsening symptoms due to increased intraocular pressure. Patients with tuberculous disease or herpes simplex keratitis may also have exacerbated symptoms due to immune suppression. Patients with posterior capsule cataracts may have deteriorating eye conditions, and those with electrolyte abnormalities or hypertension may experience aggravated symptoms. Individuals with thromboembolic disorders risk worsening thrombosis, and those who have recently undergone bowel surgery may experience delayed wound healing. Patients who have had acute myocardial infarction, diverticulitis, peptic ulcer, mental illness, or severe osteoporosis also require special caution when using this medication. Furthermore, patients with infections, diabetes, renal failure, congestive heart failure, hypothyroidism, fatty liver, myasthenia gravis, the elderly, individuals with epilepsy, and those with ulcerative colitis should be administered this medication carefully. Using this medication can result in various side effects, so careful monitoring is required. Fluid and electrolyte imbalances can lead to edema or hypertension, and musculoskeletal issues such as muscle weakness, osteoporosis, joint pain, and tendon rupture may occur. Gastrointestinal issues can include nausea, vomiting, appetite changes, peptic ulcers, and pancreatitis, while the skin may become thin and prone to bleeding, acne, and hair loss. Neuropsychiatric side effects may include headaches, dizziness, insomnia, and depression. Endocrine side effects can manifest as Cushing's syndrome, menstrual disturbances, growth suppression, and worsening diabetes, and eye health may be affected, necessitating regular examinations for glaucoma, cataracts, and secondary infection risks. Additionally, immune system abnormalities and allergic reactions have been reported. Long-term use of this medication can lead to adrenal insufficiency, with severe withdrawal symptoms possibly occurring if it is stopped abruptly. Therefore, the dosage should be gradually reduced, and in stressful situations such as surgery or infection, temporary increases in dosage may be necessary. During long-term treatment, using the minimum effective dose is recommended, typically administering it in the morning or every other day. Moreover, special attention should be paid to infections during the use of this medication. Immune suppression may make patients more susceptible to infections like chickenpox or measles, so vaccination history and infection history should be verified, and if infections are suspected or develop, prompt medical attention should be sought. This medication cannot be used with live vaccines, and care must be taken as infection symptoms may be obscured. This medication can interact with various other drugs, so it is essential to inform your doctor about any concomitant medications. Co-administration with certain drugs may increase side effects or decrease the effectiveness of this medication, so dosage adjustments should be performed according to medical advice. Women who are pregnant or may become pregnant should carefully consider the benefits and risks of this medication as it may affect the fetus. Additionally, it can be passed to the baby through breast milk, so it's advisable not to use it during breastfeeding. When administering to children, minimum doses should be used to avoid growth retardation, and growth status should be closely monitored. Older adults are at higher risk of side effects related to infections, diabetes, osteoporosis, and hypertension, so they require careful administration. It is essential to fully understand the precautions and side effects mentioned above when using this medication and to strictly follow the physician's instructions. If any unusual symptoms occur, notify medical personnel immediately to receive appropriate action.

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, muscle atrophy, pathologic fractures of the ilium, osteoporosis, vertebral compression fractures, arthralgia, tendon rupture, increased ALT, increased AST, increased ALP, nausea, dry mouth, vomiting, gastric pain, anorexia, increased appetite, peptic ulcer, abdominal bloating, pancreatitis, ulcerative esophagitis, diarrhea, delayed wound healing, erythema, thin and fragile skin, abnormal sweating, petechiae, purpura, suppression of skin reactions, purpura, acne, hirsutism, hair loss, pigmentation, increased intracranial pressure, papilledema, seizures, dizziness, headaches, 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 infections, central serous chorioretinopathy, retinal disorders, exophthalmos, negative nitrogen balance, 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 closed container to prevent exposure to air or moisture. It is essential to maintain a storage temperature between 1 and 30 degrees Celsius (room temperature) to preserve the medication's efficacy and safety.

Appearance and packaging

Appearance

White round tablet

Package unit

30 tablets/bottle, 300 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.