Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
PREDNISONE (UNII: VB0R961HZT) (PREDNISONE - UNII:VB0R961HZT)
STAT RX USA LLC
PREDNISONE
PREDNISONE 10 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, nonsuppurative thyroiditis, hypercalcemia associated with cancer. 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 lupu
Prednisone Tablets USP, 5 mg: White, round tablets, scored on one side and “West-ward 475” debossed on the other side. Each tablet contains 5 mg of prednisone for oral administration. Blister Pack of 21 tablets NDC# 45802-733 -21 Blister Pack of 48 tablets NDC# 45802-733 -67 Prednisone Tablets USP, 10 mg: White, round tablets, scored on one side and “West-ward 473” debossed on the other side. Each tablet contains 10 mg of prednisone for oral administration. Blister Pack of 21 tablets NDC# 45802-303 -21 Blister Pack of 48 tablets NDC# 45802-303 -67 Store at 20-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Manufactured by: West-ward Pharmaceutical Corporation Eatontown, NJ 07724 DISTRIBUTED BY PERRIGO® ALLEGAN, MI 49010 PREDNISONE TABLETS Revised 09/07 0P800 RC J4
Abbreviated New Drug Application
PREDNISONE - PREDNISONE TABLET STAT RX USA LLC ---------- PREDNISONE TABLETS RX ONLY DESCRIPTION Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The molecular formula for prednisone is C21H26O5. Chemically, it is 17,21-dihydroxypregna-1, 4-diene-3,11, 20-trione and has the following structural formula: PREDNISONE DP 10MG STRUCTURE IMAGE Prednisone is a white to practically white, odorless, crystalline powder and has a molecular weight of 358.44. It melts at about 230°C with some decomposition. Prednisone is very slightly soluble in water, slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 5 mg or 10 mg of prednisone. Inactive ingredients: 5 MG: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc. 10 MG: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc. 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, such as prednisone, are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids, such as prednisone, cause profound and varied metabolic effects. In addition, they modify the body’s immune response to diverse stimuli. INDICATIONS AND USAGE 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, nonsuppurative thyroiditis, hypercalce Baca dokumen lengkap