البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
MEDROL Tablets are indicated in the following conditions: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Synovitis of osteoarthritis Acute nonspecific tenosynovitis Post-traumatic osteoarthritis Psoriatic arthritis Epicondylitis Acute gouty arthritis During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis Bullous der
MEDROL Tablets are available in the following strengths and package sizes: 2 mg (white, elliptical, scored, imprinted MEDROL 2) Bottles of 100 NDC 0009-0020-01 4 mg (white, elliptical, scored, imprinted MEDROL 4) Bottles of 100 NDC 0009-0056-02 DOSEPAK ™ Unit of Use (21 tablets) NDC 0009-0056-04 8 mg (white, elliptical, scored, imprinted MEDROL 8) Bottles of 25 NDC 0009-0022-01 16 mg (white, elliptical, scored, imprinted MEDROL 16) Bottles of 50 NDC 0009-0073-01 32 mg (white, elliptical, scored, imprinted MEDROL 32) Bottles of 25 NDC 0009-0176-01 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
New Drug Application
MEDROL- METHYLPREDNISOLONE TABLET REMEDYREPACK INC. ---------- MEDROL METHYLPREDNISOLONE TABLETS, USP DESCRIPTION MEDROL Tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6- methyl-, (6α,11β)-and the molecular weight is 374.48. The structural formula is represented below: Each MEDROL Tablet for oral administration contains 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. Inactive ingredients: 2 MG 4 MG AND 8 MG Calcium Stearate Calcium Stearate Corn Starch Corn Starch Erythrosine Sodium Lactose Lactose Sucrose Mineral Oil Sorbic Acid Sucrose 16 MG AND 32 MG Calcium Stearate ® Corn Starch Lactose Mineral Oil Sucrose ACTIONS Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli. INDICATIONS AND USAGE MEDROL Tablets are indicated in the following conditions: 1. ENDOCRINE DISORDERS Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associat اقرأ الوثيقة كاملة