Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
PREDNISONE (UNII: VB0R961HZT) (PREDNISONE - UNII:VB0R961HZT)
RedPharm Drug, Inc.
PREDNISONE
PREDNISONE 20 mg
ORAL
PRESCRIPTION DRUG
Prednisone Tablets, USP are indicated in the following conditions: 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. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: systemic lu
Abbreviated New Drug Application
PREDNISONE- PREDNISONE TABLET REDPHARM DRUG, INC. ---------- SPL UNCLASSIFIED SECTION PREDNISONE TABLETS, USP Rx Only DESCRIPTION Each tablet for oral administration contains: Prednisone.................................................5 mg, 10 mg and 20 mg Inactive Ingredients Prednisone Tablets, USP of 5 mg and 10 mg strengths contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc. Prednisone Tablets, USP of 20 mg strength contain anhydrous lactose, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Prednisone Tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna- 1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below: [structural formula] C21H26O5 M.W. 358.43 Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. 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 Prednisone Tablets, USP are indicated in the following conditions: 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 supplem Preberite celoten dokument