Pidron Tablet 4 mg (Methylprednisolone)

Adult dosage

1. The initial dosage 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 obtained. If satisfactory clinical results are not achieved after a reasonable period, treatment should be discontinued and another appropriate treatment initiated. The dosage must be determined individually according to the various diseases being treated and the patient's response. After an adequate response is 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. Dosage requires continuous monitoring. Situations that may require dosage adjustment include remission or worsening of the disease, individual variation in the patient's response to the drug, and the effect on the patient of exposure to stressful circumstances 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 achieve satisfactory control of the patient's condition. After long-term treatment, gradual dose reduction is recommended when discontinuing the drug. 2. Multiple sclerosis 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). 3. ADT (Alternate Day Therapy) Alternate-day therapy is a regimen in which twice the daily dose is administered on one morning out of every two days. The purpose of this regimen is to enhance the effects of corticosteroids in patients requiring long-term drug therapy and to minimize adverse effects such as pituitary-adrenal suppression, a Cushingoid state, corticosteroid withdrawal symptoms, and growth suppression in children. The rationale for this treatment plan is based on the following two important premises: 1) The anti-inflammatory and therapeutic effects of corticosteroids persist longer than their physical presence and metabolic effects; and 2) Taking corticosteroids in the morning every other day allows nearly normal hypothalamic-pituitary-adrenal (HPA) activity to be reestablished on the days when corticosteroids are not administered. A brief summary of HPA physiology may help explain this rationale. Free cortisol acts primarily through the hypothalamus; therefore, a decrease in free cortisol stimulates the pituitary gland to increase adrenocorticotropic hormone (ACTH) production, whereas an increase in free cortisol suppresses ACTH secretion. Normally, the HPA system is characterized by a 24-hour activity rhythm. Serum ACTH levels rise from a low level at 10 p.m. to a peak at 6 a.m. The rise in ACTH stimulates adrenocortical activity, causing plasma cortisol to peak between 2-8 a.m. This increase in cortisol decreases ACTH production and, in turn, reduces adrenocortical synthesis. As a result, plasma corticosteroid levels gradually decrease during the day and reach a minimum around midnight. The 24-hour HPA rhythm is absent in Cushing's disease, a condition characterized by hyperadrenocorticism with symptoms including obesity with central fat distribution, thin skin that bruises easily, weakness and muscle wasting, hypertension, latent diabetes, osteoporosis, and electrolyte imbalance. The clinical symptoms of the same hyperadrenocorticoism may typically occur during long-term corticosteroid drug therapy administered in divided doses throughout the day. If they occur, disruption of the diurnal rhythm due to maintenance of elevated corticosteroid levels during the night is likely to play an important role in the development of corticosteroid adverse effects. Avoiding continuously elevated plasma concentrations, even for a short period, may help prevent adverse effects. During treatment with typical pharmacologic doses of corticosteroids, ACTH production is suppressed along with inhibition of cortisol production by the adrenal cortex. The time required for recovery of normal HPA activity varies according to the dose and duration of treatment. During this period, the patient is sensitive to any stressful circumstances. Although a single morning dose produces substantially less adrenal suppression than taking prednisolone (10mg) in four 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. Other corticosteroids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered short-acting (a single dose produces adrenocortical suppression for 1¼ to 1½ days) and are therefore recommended for alternate-day therapy. The following points should be kept in mind when using alternate-day therapy. 1) The basic principles and indications for corticosteroid therapy should be applied. The advantages of ADT should not encourage indiscriminate use of corticosteroids. 2) ADT is a treatment technique that should generally be planned for patients requiring long-term corticosteroid drug therapy. 3) ADT may be used initially for less severe diseases for which corticosteroid therapy is indicated. In more severe diseases, a regimen of high doses in divided daily doses will usually be required to achieve initial control of disease progression. 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. 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, two approaches are possible. 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, approach ① is preferable. 4) Because of the advantages of ADT, this form of treatment is desirable for patients who have taken corticosteroids daily for a long time (for example, rheumatoid arthritis). Since the HPA axis may already be suppressed in these patients, establishing ADT may be difficult and is not always successful. However, regular attempts to make the change are recommended. If difficulties arise, it is preferable to administer three or even four times the daily dose every other day rather than merely doubling the daily dose. Once the patient is again controlled, attempts should be made to reduce this dose to the minimum. 5) As mentioned above, some corticosteroids suppress adrenal function for a prolonged period and are therefore not recommended for alternate-day therapy (for example, dexamethasone, betamethasone). 6) Adrenal cortical activity is highest from 2 a.m. to 8 a.m. and lowest from 4 p.m. to midnight. When administered during the period of peak activity (in the morning), exogenous corticosteroids suppress adrenocortical activity the least. 7) As with any treatment setting, when using ADT it is important to provide individualized and appropriate treatment for each patient. Complete control of symptoms is not possible in every patient. Explaining the advantages of ADT will help patients understand and tolerate unstable symptoms that may occur later in the day when no corticosteroid is administered. If necessary, other symptomatic treatments may be added or increased during this period. 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, alternate-day therapy as established may be attempted again. 9) Although many adverse effects of corticosteroid therapy may be minimized with ADT, as with any treatment setting, the physician must carefully consider the ratio of benefit to risk of treatment for each patient for whom corticosteroid therapy is being considered.

This medication should not be administered to certain patients. For instance, it should not be given to those who are allergic to this drug or its components, or to patients with infections or systemic fungal infections where effective antibacterial agents are absent, as it may worsen the infection. It should also not be administered to patients with herpes simplex, herpes zoster, varicella, or those receiving live vaccines. Additionally, patients with lactose intolerance or certain genetic issues should not take this drug due to its lactose content. This medication should be used cautiously in patients with a history of glaucoma, tuberculosis, subcapsular cataract, hypertension, thrombosis, and acute myocardial infarction, as there is a risk of worsening symptoms. Patients with conditions such as diabetes, osteoporosis, renal failure, hypothyroidism, fatty liver, severe myasthenia gravis, the elderly, epilepsy, and peptic ulcer should also be monitored closely when prescribed this medication. Side effects may include fluid retention, sodium retention, hypokalemia, muscle weakness, osteoporosis, gastrointestinal disturbances, skin changes, neuropsychiatric symptoms, endocrine system abnormalities, and eye-related issues, thus close observation of symptoms is necessary. In long-term use, serious side effects such as adrenal insufficiency may occur, so the medication should not be suddenly discontinued but gradually tapered off. There is also an increased risk of infection, so patients should be cautious about exposure to diseases like chickenpox or measles. This drug may interact with other medications, so it is important to inform healthcare providers of any concurrent medications, especially when taking cardiovascular drugs, antibiotics, diuretics, anticoagulants, or antidiabetic agents. Pregnant or breastfeeding women should use this medication under careful guidance from a doctor to avoid potential impacts on the fetus or newborn, and it is advisable to discontinue breastfeeding. In children, there is a risk of growth suppression, so the minimal effective dose should be used and growth closely monitored. Elderly patients have a higher risk of side effects, so caution should be exercised during administration. Lastly, if the patient is infected with chickenpox or measles during the course of this medication, it could be fatal; therefore, medical history and vaccination status should be confirmed, and immediate medical attention should be sought if infection is suspected.

Edema, sodium retention, potassium loss, fluid retention, hypokalemic alkalosis, congestive heart failure, hypertension, myasthenia, avascular necrosis of the femur and humerus, steroid myopathy, muscle wasting, pathologic fractures of the pelvis, osteoporosis, vertebral compression fractures, arthralgia, tendon rupture, elevated ALT, elevated AST, elevated ALP, nausea, thirst, vomiting, abdominal pain, loss of appetite, increased appetite, peptic ulcer, abdominal distension, pancreatitis, esophageal ulceration, diarrhea, delayed wound healing, facial erythema, thin and fragile skin, abnormal sweating, petechiae, purpura, skin reaction suppression, purpura, acne, hirsutism, alopecia, pigmentation, nipple edema, increased intracranial pressure, convulsions, dizziness, headache, insomnia, euphoria, depression, Cushing's syndrome, menstrual irregularities, growth suppression, latent diabetes symptoms, adrenal insufficiency, pituitary unresponsiveness, reduced glucose tolerance, increased requirements for insulin or hypoglycemic agents, suppression of adrenocorticotropic hormone secretion, increased intraocular pressure, glaucoma, subcapsular cataract, secondary eye infections, retinal disorders, exophthalmos, negative nitrogen balance, immune system disturbances, allergic reactions, shock, urticaria, anaphylactic reactions, hypersensitivity reactions

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. The storage temperature should ideally be maintained between 1 degree and 30 degrees Celsius.

Appearance

White oval tablet

Package unit

Bottle - 30 tablets/bottle, Bottle - 500 tablets/bottle