Medication info

Entimep Tablet 4 mg (Methylprednisolone)

Prescription medicationTabletEar dropsExpired
Ingredient · strength
Methylprednisolone›4mg / 1 tablet
Manufacturer / importer
Korea Sintex Pharmaceutical Co., Ltd.
Appearance
White round tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201906155 · Approved 2019.08.29

This product's status changed to Expired on 2024.08.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of inflammatory, immune, and allergic diseases; endocrine, hematologic, and edematous diseases; and neoplastic and infectious diseases
Who applies the ear drops
Adults
Adult use
1. The initial dose may vary from 4mg to 48mg 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 achieved. If there is no satisfactory clinical result after a reasonable period, discontinue treatment and switch to another appropriate treatment. The dose must be determined individually 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. The dose requires ongoing monitoring. Dose adjustment may be necessary in circumstances including remission or worsening of the disease, the individual patient's response to the medicine, and the effect on the patient of exposure to stressful situations 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 appropriate to the patient's condition. After long-term treatment, gradual dose reduction is recommended when discontinuing the medicine. 2. 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). 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 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, a slight suppressive effect on adrenal activity continues into the following day. 4) Because of the advantages of ADT, this form of treatment is desirable for patients who have taken corticosteroids daily for a long period (e.g., patients with rheumatoid arthritis). Establishing ADT may be difficult and not always successful in these patients because the HPA axis may already be suppressed. However, regular attempts to switch are recommended. If this is difficult, administering 3 times or even 4 times the daily dose every other day is preferable to simply doubling the daily dose. Once the patient is again controlled, attempt to reduce this dose to the minimum.

Ingredients

Manufacturer
Korea Sintex Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used for various diseases. Among endocrine disorders, it is effective for adrenal cortical insufficiency, congenital adrenal hyperplasia, hypercalcemia caused by cancer, etc. It is used for rheumatic diseases such as acute osteoarthritis, rheumatoid arthritis, and gouty arthritis, and is also helpful in treating connective tissue diseases like systemic lupus erythematosus and dermatomyositis. Additionally, it applies to skin diseases such as pemphigus and psoriasis, and allergic conditions such as bronchial asthma and atopic dermatitis. It can also be used as an adjunct therapy for inflammatory diseases of the eye, gastrointestinal diseases like ulcerative colitis, respiratory diseases such as pulmonary tuberculosis, blood disorders like autoimmune hemolytic anemia and thrombocytopenia, and for malignant tumors. Furthermore, it is effectively utilized for improving symptoms in various conditions such as nephrotic syndrome, acute exacerbations of multiple sclerosis, and tuberculous meningitis.

How to apply ear drops

Adult use

1. The initial dose may vary from 4mg to 48mg 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 achieved. If there is no satisfactory clinical result after a reasonable period, discontinue treatment and switch to another appropriate treatment. The dose must be determined individually 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. The dose requires ongoing monitoring. Dose adjustment may be necessary in circumstances including remission or worsening of the disease, the individual patient's response to the medicine, and the effect on the patient of exposure to stressful situations 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 appropriate to the patient's condition. After long-term treatment, gradual dose reduction is recommended when discontinuing the medicine. 2. 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). 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 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, a slight suppressive effect on adrenal activity continues into the following day. 4) Because of the advantages of ADT, this form of treatment is desirable for patients who have taken corticosteroids daily for a long period (e.g., patients with rheumatoid arthritis). Establishing ADT may be difficult and not always successful in these patients because the HPA axis may already be suppressed. However, regular attempts to switch are recommended. If this is difficult, administering 3 times or even 4 times the daily dose every other day is preferable to simply doubling the daily dose. Once the patient is again controlled, attempt to reduce this dose to the minimum.

Precautions

This drug should not be used in patients who have an allergy or hypersensitivity to this drug or its components. In patients with infections, especially those with infections where antimicrobial agents are ineffective or systemic fungal infections, this drug can suppress immune function and worsen infections, so it should not be administered. Administration of this drug is also prohibited in patients with herpes simplex, herpes zoster, and chickenpox. Patients receiving live vaccines or attenuated live vaccines should not use this drug. Additionally, this drug contains lactose, so patients with genetic lactose intolerance, galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medication. Caution should be exercised when administering this drug to patients with a history of glaucoma, tuberculosis, keratitis, cataracts, electrolyte abnormalities, hypertension, thromboembolism, recent bowel anastomosis surgery, history of myocardial infarction, diverticulitis, peptic ulcers, psychosis, osteoporosis, among others, and it should only be administered when necessary. Patients with infections or diabetes, renal failure, congestive heart failure, hypothyroidism, fatty liver, fat embolism, myasthenia gravis, elderly patients, epilepsy, ulcerative colitis, and various other conditions should also be closely monitored. While taking this drug, various side effects such as edema, increased blood pressure, muscle weakness, osteoporosis, gastrointestinal disorders, skin changes, psychiatric symptoms, endocrine abnormalities, and visual disturbances may occur, therefore symptoms should be carefully observed. Particularly with long-term use, adrenal insufficiency may develop, and sudden discontinuation of the drug can be dangerous, so it should be tapered gradually under a doctor's instruction. Due to immunosuppressive effects, the risk of infection is increased. Care should be taken to avoid exposure to chickenpox or measles, and if infection is suspected, immediate consultation should be sought. This drug interacts with many other medications, so careful dosage adjustments or caution is required when taken with specific drugs. During pregnancy, it may be harmful to the fetus, so it should only be used when strictly necessary, and during breastfeeding, the medication can pass through breast milk, necessitating cessation of breastfeeding.

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 wasting, pathologic fractures of the pelvis, osteoporosis, spinal compression fractures, arthralgia, tendon rupture, increased ALT, increased AST, increased ALP, nausea, dry mouth, vomiting, stomach pain, loss of appetite, increased appetite, peptic ulcer, abdominal distension, pancreatitis, ulcerative esophagitis, diarrhea, delayed wound healing, facial flushing, 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, euphoric state, depression, Cushing's syndrome, menstrual irregularities, growth retardation in children, symptoms of latent diabetes, secondary adrenal insufficiency, pituitary unresponsiveness, reduced glucose tolerance, increased requirement for insulin or oral hypoglycemics, suppression of adrenocorticotropic hormone secretion, increased intraocular pressure, glaucoma, subcapsular cataract, secondary infections of the eye, central serous chorioretinopathy, retinal disorders, exophthalmos, negative nitrogen balance due to protein catabolism, immune system disorders, allergic reactions, shock, urticaria, anaphylactic reaction, 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 should be stored in a tightly closed container. The storage temperature should ideally maintain room temperature between 1 degree and 30 degrees Celsius. Storing it this way helps safely maintain the drug's effectiveness.

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.