Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
Prednisone (UNII: VB0R961HZT) (Prednisone - UNII:VB0R961HZT)
Blenheim Pharmacal, 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, scored, imprinted with TL172) Bottles of 100 NDC 59746-172-06 Bottles of 1000 NDC 59746-172-10 10 mg (white, round, scored, imprinted with TL173) Bottles of 100 NDC 59746-173-06 Bottles of 500 NDC 59746-173-09 Bottles of 1000 NDC 59746-173-10 20mg (peach, round, scored, imprinted with TL175) Bottles of 100 NDC 59746-175-06 Bottles of 500 NDC 59746-175-09 Bottles of 1000 NDC 59746-175-10 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 03/11
Abbreviated New Drug Application
PREDNISONE - PREDNISONE TABLET BLENHEIM PHARMACAL, 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 juven Baca dokumen lengkap