Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
Prednisone (UNII: VB0R961HZT) (Prednisone - UNII:VB0R961HZT)
Preferred Pharmaceuticals Inc.
Prednisone
Prednisone 5 mg
ORAL
PRESCRIPTION DRUG
Prednisone 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 2. 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. 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic derznatomyositis
Prednisone Tablets, USP are available in the following strengths and package sizes: 5 mg (White, round tablets debossed with "TL 172" on one side and scored on the other side) Bottles of 10 NDC 68788-7372-1 Bottles of 20 NDC 68788-7372-2 Bottles of 21 NDC 68788-7372-8 Bottles of 30 NDC 68788-7372-3 Bottles of 40 NDC 68788-7372-4 Bottles of 90 NDC 68788-7372-9 10 mg (White, round tablets debossed with "TL 173" on one side and scored on the other side) Bottles of 10 NDC 68788-6440-1 Bottles of 15 NDC 68788-6440-6 Bottles of 20 NDC 68788-6440-2 Bottles of 21 NDC 68788-6440-8 Bottles of 30 NDC 68788-6440-3 Bottles of 40 NDC 68788-6440-4 Bottles of 45 NDC 68788-6440-7 Bottles of 50 NDC 68788-6440-5 Bottles of 90 NDC 68788-6440-9 Store at 20° to 25° C (68° to 77° F) [See USP Room Temperature]. Manufactured By: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. Revised 01/2018
Abbreviated New Drug Application
PREDNISONE- PREDNISONE TABLET PREFERRED PHARMACEUTICALS INC. ---------- PREDNISONE TABLETS, USP RX ONLY DESCRIPTION Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1, 4-diene-3, 11, 20-trione, 17, 21-dihydroxy- The structural formula is represented below: Molecular weight: 358.44 Prednisone Tablets, USP are available in three strengths: 5 mg, 10 mg, and 20 mg. In addition, each tablet contains the following Inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains FD & C yellow #6 aluminum lake HT 15-18%. 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 Prednisone 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 2. 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 Lesen Sie das vollständige Dokument