Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
PREDNISONE (UNII: VB0R961HZT) (PREDNISONE - UNII:VB0R961HZT)
Direct_Rx
PREDNISONE
PREDNISONE 20 mg
ORAL
PRESCRIPTION DRUG
Prednisone tablets 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 lupus erythematosus
Prednisone Tablets USP 5 mg are scored, round, white tablets imprinted DAN DAN and 5052 supplied in bottles of 100 and 1000. Prednisone Tablets USP 10 mg are scored, round, white tablets imprinted DAN DAN and 5442 supplied in bottles of 100, 500 and 1000. Prednisone Tablets USP 20 mg are scored, round, peach tablets imprinted DAN DAN and 5443 supplied in bottles of 100, 500 and 1000. Dispense in a well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]
Abbreviated New Drug Application
PREDNISONE- PREDNISONE TABLET DIRECT_RX ---------- PREDNISONE DESCRIPTION SECTION Prednisone tablets 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: C21H26O5 M.W. 358.44 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. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of prednisone USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone Tablets USP 20 mg also contain FD&C Yellow No. 6. CLINICAL PHARMACOLOGY SECTION 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 antiinflammatory 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 & USAGE SECTION Prednisone tablets 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 exacerbat Przeczytaj cały dokument