Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)
Ingenus Pharmaceuticals, LLC
ORAL
PRESCRIPTION DRUG
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 Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2.Rheumatic Disorders 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 3.Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus
Methylprednisolone tablets, USP are supplied as follows: 4 mg tablets: White to off-white, elliptical shaped, flat faced bevel edged tablets debossed with "ING" above "615" on one side and double scoreline (quadrisect) on the other side, available in bottles of 100 and unit of use blister packages of 21. Bottles of 100 - NDC 50742-189-01 Unit of use blister packages of 21 tablets - NDC 50742-189-21 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in USP with child resistant closure.
Abbreviated New Drug Application
METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET INGENUS PHARMACEUTICALS, LLC ---------- METHYLPREDNISOLONE TABLETS, USP DESCRIPTION Methylprednisolone Tablets, USP 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 methylprednisolone tablet, USP for oral administration contains 4 mg of methylprednisolone, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, lactose monohydrate, pregelatinized starch, microcrystalline cellulose and magnesium stearate. 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 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 Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2.RHEUMATIC Läs hela dokumentet