MEDIXON Methylprednisolone 4mg Tablet 1's

Treatment of Abnormal Adrenocorticoid Function: Primary acute and chronic adrenocortical insufficiency. Hydrocortisone and cortisone are preferred as adjunctive replacement therapy because of their significant mineralocorticoid activities. Replacement of sodium and fluids is required. In some patients, additional mineralocorticoid replacement may also be necessary.
Secondary Adrenocorticoid Insufficiency: Glucocorticoid replacement is usually sufficient, a mineralocorticoid is not always required.
Allergic Disorders: Drug allergy, anaphylactic or anaphylactoid reaction (adjunctive therapy). Use of glucocorticoids is generally reserved for prolonged reactions (those not responding to other forms of treatment within 1 hr) or situations in which there is a significant risk of relapse. Angioedema (adjunctive therapy); acute noninfectious laryngeal edema; seasonal or perennial allergic rhinitis (chronic or acute); serum sickness; urticarial transfusion reaction.
Collagen Disorders: During an acute exacerbation or as maintenance therapy in the cases of: Acute rheumatic (or nonrheumatic) carditis. Systemic dermatomyositis (polymyositis). Glucocorticoids may be the treatment of choice in children with this condition. Systemic lupus erythematosus; 'giant-cell' arthritis (temporary); complicated bound tissue disease; polyarthritis nodosa; polychondritis relapse; rheumatoid polymyalgia; vasculitis.
Dermatologic Disorders: Atopic, contact or exfoliative dermatitis; bullous dermatitis herpetiformis; moderate seborrheic dermatitis; moderate inflammatory dermatitis; moderate erythema multiforme (Stevens-Johnson syndrome); mycosis fungoides; pemphigus; moderate psoriasis; pemphigoid; localized cutaneous sarcoid.
GI Disorders: Treatment of the inflammatory bowel disease, including ulcerative colitis, regional enteritis (Crohn's disease), moderate cellac disease. Oral or parenteral administration is indicated when systemic therapy is required during a clinical period of the disease; long-term use is not recommended.
Hematologic Disorders: Acquired hemolytic anemia (autoimmune), congenital (erythroid) hypoplastic anemia, red blood cell anemia (erythroblastopenia), secondary thrombocytopenia (in adults), idiopathic thrombocytopenia purpura in adults (oral or IV administration only, IM administration is contraindicated), hemolysis.
Hepatic Disease: Alcoholic hepatitis with encephalopathy, chronic active hepatitis, nonalcoholic hepatitis in women, subacute hepatic necrosis.
Hypercalcemia associated with neoplasms (or sarcoidosis).
Nonrheumatoid Inflammation: During an acute episode or exacerbation of the following disorders (local injection is preferred when only a few joints or areas are affected): Acute and subacute bursitis, epicondylitis, acute nonspecific tenosynovitis.
Neoplastic Disease (Adjunctive Therapy): In conjunction with appropriate specific antineoplastic disease therapy for the palliative management of the following neoplastic diseases and related problems: Acute leukemia or chronic lymphocytic, Hodgkin's or non-Hodgkin's lymphomas, breast and prostatic cancer, fever caused by severe cancer, multiple myeloma.
Nephrotic Syndrome: To induce diuresis or to reduce proteinuria symptoms in idiopathic nephrotic syndrome; long-term therapy may be required to prevent frequent relapses.
Neurologic Disease: Tuberculosis meningitis (adjunctive therapy), concurrent administration with appropriate antituberculous chemotherapy in patients with subarachnoid block. Treatment of acute exacerbations in multiple sclerosis.
Neurotrauma: Spinal cord injury.
Ophthalmic Disorders: Treatment of chronic or acute allergic and inflammatory ophthalmic conditions eg, chorioretinitis, choroiditis posterior diffusion, allergic conjunctivitis (controlled diffuse posterior choroiditis), herpes zoster, iridocyclitis, keratitis not associated with herpes simplex or fungal infection, optic neuritis, sympathetic ophthalmia, diffuse posterior uveitis.
Pericarditis: Used to eliminate inflammation and fever. Nasal polyps.
Treatment and prophylaxis of respiratory diseases.
Prophylaxis: Given before or during heart surgery if patient has a preexisting pulmonary disorder, and given before, during and after oral, facial or neck surgery to prevent edema that may inhibit the airway. Treatment of bronchial asthma; berylliosis; Loeffler syndrome (eosinophilic pneumonitis or hypereosinophilic syndrome); aspiration pneumonia; symptomatic sarcoidosis; fulminating or disseminated pulmonary tuberculosis (treatment adjunct) when used concurrently with appropriate tuberculosis chemotherapy; acute and chronic asthmatic bronchitis; noncardiogenic pulmonary edema (caused by protamine sensitivity, treatment should be administered IV/IM injection); Pneumocystis carinii pneumonia associated with AIDS (treatment adjunct), in patients infected with HIV virus with Pneumocystis pneumonia; chronic obstructive pulmonary disease (not controlled with theophylline and β-adrenergic agonist; status asthmaticus should be given by IV/IM injection.
Airway-obstructing hemangioma; medication in children should be administered by IV/IM injection.
Rheumatic Disorders: Local injections should be applied if only few joints or areas are involved; adjunctive therapy during an acute episode or exacerbation of rheumatic disorders eg, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis [(including arthritis in children), for patients that cannot be treated with aspirin, steroidal anti-inflammatory drugs, rest and physical therapy]; acute gouty arthritis; post-traumatic osteoarthritis, osteoarthritis synovitis, acute calcium pyrophosphate deposition disease (pseudo-gout chondrocalcinosis, synovitis caused by crystals); rheumatica polymyalgia; Reiter's disease.
Shock therapy caused by adrenocortical insufficiency; nonsuppurative thyroiditis.
Prophylaxis and treatment in organ transplant rejection administered concurrently with other immunosuppressants eg, azathioprine or cyclosporine; trichinosis treatment.

Adults: Initial Dose: 4-48 mg daily. Single or multiple dose depending on the condition being treated.
Multiple Sclerosis: 160 mg daily for 1 week then 64 mg/2 days for 1 month. Children: Adrenocortical Insufficiency: 0.117 mg/kg body weight or 3.33 mg/m² body surface area (BSA)/day in 3 or 4 divided doses.
Other: 0.417-1.67 mg/kg body weight or 12.5-50 mg/m² BSA/day orally in 3-4 divided doses.
It is recommended that Medixon tablets be administered concomitantly with food to minimize GI irritation.

Should be taken with food.

Known hypersensitivity to methylprednisolone and systemic fungal infections.
Peptic ulcer.
Premature infants. Long-term treatment in patients with ulcus duodenum and pepticum, severe osteoporosis; patients with history of mental disease (psychosis), herpes and during immunization.

While being treated with corticosteroid, patients should not be vaccinized or immunized to smallpox, especially with high doses to prevent the possibility of neurologic complications.
If corticosteroid is applied in patients with latent tuberculosis or tuberculin reactivity, patients should be observed carefully as reactivation of the disease may occur.
Corticosteroids effects may increase in patients with hypothyroidism or cirrhosis.
Use with caution in patients with ocular herpes simplex because of possible corneal perforation.
Medixon can suppress clinical symptoms of an infectious disease.
Long-term treatment may decrease the body's stamina to infectious disease.
Use in pregnancy & lactation: Methylprednisolone may cause fetal damage when administered to pregnant women. Corticosteroids can diffuse into breast milk and placenta and may cause side effects and suppress growth in nursing infants.
Use in children: The administration of glucocorticoids in children should be avoided because it may cause retardation. If therapy is necessary, infant growth should be closely monitored. Alternate-day therapy given as a single dose in the morning may minimize growth suppression and should be instituted if growth is minimized. High doses of glucocorticoids in children may cause acute pancreatitis followed by pancreatic destruction.
Use in the elderly: Hypertension may occur during adrenocorticoid therapy. Geriatric patients, especially postmenopausal women, may also be more likely to develop glucocorticoid-induced osteoporosis.

Adrenocortical Insufficiency: The high doses of glucocorticoids for prolonged periods can decrease endogenous corticosteroid secretion by suppressing pituitary release of corticotropin (secondary adrenocortical insufficiency).
Musculoskeletal Effect: Muscle pain or muscle weakness, atrophy of the bound protein matrix resulting in osteoporosis, vertebral compression fractures, aseptic necrosis of humeral or temporal heads, or pathology fractures of long bones.
Fluid and Electrolyte Disturbances: Sodium retention with resultant edema, potassium loss, hypokalemic alkalosis, hypertension, congestive heart failure. Ocular Effects: Posterior subcapsular cataracts increasing intraocular pressure, glaucoma, exophthalmos.
Endocrine Effects: Irregular menstruation, cushingoid state and inhibition of children's growth, decreased glucose tolerance, hyperglycemia, aggravated diabetes mellitus.
Gastrointestinal Tract Effects: Nausea, vomiting, anorexia which may result in weight loss, increasing appetite, increasing body weight, diarrhea or constipation, abdominal distention, pancreatitis, gastric irritation, ulcerative esophagitis, reactivation perforation, hemorrhage and delayed healing of peptic ulcers.
Nervous System Effects: Headache, vertigo, insomnia, increased motor activity, ischemic neuropathy, electroencephalogram abnormalities and convulsion.
Dermatological Effects: Skin atrophy, acne, increased sweating, hirsutism, facial erythema, striae, allergic dermatitis, urticaria and angioedema.
Others: Sudden discontinuation of glucocorticoid treatment will produce nausea, loss of appetite, lethargy, headache, fever, joint pain, desquamation, myalgia, weight loss and/or hypotension.

If Medixon tablet is administered concomitantly with antidiabetic drugs, the dosage should be adjusted.
Hepatic Microsomal Enzyme Inducers: Drugs eg, barbiturates, phenytoin and rifampicin which induce hepatic enzymes may increase glucocorticoid metabolism, may require dosage adjustments or the drugs not given concomitantly.
Nonsteroidal Anti-Inflammatory Agents: Concomitant administration of ulcerogenic drugs eg, indomethacin, may increase the risk of gastrointestinal tract ulceration. Aspirin should be given cautiously in patients with hypoprothrombinemia. Although concomitant administration with salicylates does not appear to increase the incidence of gastrointestinal ulceration, the possibility of this effect should be considered.
Anticholinesterase Agents: Interaction between glucocorticoids and anticholinesterase agents eg, ambenonium, neostigmine or pyridostigmine can produce weakness in patients with myasthenia gravis. If possible, anticholinesterase treatment should be discontinued at least 24 hrs before initiation of glucocorticoid therapy.
Vaccines and Toxoids: Because corticosteroids may inhibit antibody response, Medixon may cause a diminished response to toxoids and live or inactivated vaccines.
Potassium-depleting diuretics (eg, thiazides, furosemide, ethacrynic acid) and other drugs that deplete potassium eg, amphotericin B, may enhance the potassium-wasting effect of glucocorticoids. Serum potassium should be closely monitored in patients receiving glucocorticoids and potassium-depleting drugs.

Corticosteroid Hormones