Country: United States
Language: English
Source: NLM (National Library of Medicine)
METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)
Lake Erie Medical DBA Quality Care Products LLC
METHYLPREDNISOLONE
METHYLPREDNISOLONE 4 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- METHYLPREDNISOLONE TABLETS, USP 4 MG RX ONLY DESCRIPTION Methylprednisolone 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 MethylPREDNISolone Tablet for oral administration contains 4 mg methylprednisolone. Inactive ingredients: magnesium stearate, microcrystalline cellulose and sodium starch glycolate. CLINICAL PHARMACOLOGY 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 MethylPREDNISolone 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 Hypercalcemia associated with cancer Nonsuppurative thyroiditis 2. RHEUMATIC DISORDERS As adjunctive therapy for short-term administration (to tide the patient over an acute Read the complete document