Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)
Praxgen Pharmaceuticals LLC
ORAL
PRESCRIPTION DRUG
Methylprednisolone tablets, USP 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 A
Methylprednisolone Tablets, USP are available in the following strength and package sizes: 4 mg (white to off-white, oval tablet, quadrisect and debossed S555 one side and quadrisect on the other side) Bottles of 100 NDC 70625-237-01 Unit of use blister packages of 21 tablets NDC 70625-237-11 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight, child-resistant containers as defined in the USP/NF.
Abbreviated New Drug Application
METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET PRAXGEN PHARMACEUTICALS LLC ---------- METHYLPREDNISOLONE TABLETS, USP 4 MG 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 tablets, USP for oral administration contains 4 mg of methylprednisolone. Inactive ingredients: Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate. 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, USP 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 administrat Lue koko asiakirja