Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
PREDNISONE (UNII: VB0R961HZT) (PREDNISONE - UNII:VB0R961HZT)
Northwind Pharmaceuticals, LLC
PREDNISONE
PREDNISONE 10 mg in 20
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 lupus erythemato
Prednisone tablets, USP 10 mg are scored, round, white tablets imprinted “ DAN DAN ” and “ 5442 ” Supplied in bottles of 10 NDC 51655-410-53, bottles of 12 NDC 51655-410-27, bottles of 15 NDC 51655-410-54, bottles of 20 NDC 51655-410-20, bottles of 21 NDC 51655-410-21, bottles of 30 NDC 51655-410-52, and bottles of 42 NDC 51655-410-49 Dispense in a well-closed container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
PREDNISONE- PREDNISONE TABLET NORTHWIND PHARMACEUTICALS, LLC ---------- PREDNISONE TABLETS, USP REVISED: OCTOBER 2015 RX ONLY DESCRIPTION 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: C H O 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 Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt- 21 26 5 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 supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. RHEUMATIC DISORDERS As adjunctive therapy for short-term administrati Lugege kogu dokumenti