PREDNISONE- prednisone tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

PREDNISONE (UNII: VB0R961HZT) (PREDNISONE - UNII:VB0R961HZT)

可用日期:

Bryant Ranch Prepack

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Prednisone tablets 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 Hypercalcemia associated with cancer 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 dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions 6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis 7. Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus 11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12. Nervous System Acute exacerbations of multiple sclerosis 13. Miscellaneous Tuberculous meningitis with subarachnoid block or, impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement. Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components.

產品總結:

Prednisone Tablets, USP are available in the following strengths and package sizes: 1 mg (White, round tablets debossed with "TL 171" on one side and scored on the other side.) Bottles of 1000 NDC 63629-2434-1 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

授权状态:

Abbreviated New Drug Application

产品特点

PREDNISONE - PREDNISONE TABLET
BRYANT RANCH PREPACK
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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. The molecular formula for prednisone is C
H
O . Chemically, it is 17,21-
dihydroxypregna-1,4-diene-3,11,20-trione and has the following
structural formula:
Molecular weight: 358.44
Prednisone is a white to practically white, odorless, crystalline
powder. It melts at about
230°C with some decomposition. Prednisone is very slightly soluble in
water; slightly
soluble in alcohol, in chloroform, in dioxane, and in methanol.
Each tablet, for oral administration, contains 1 mg of prednisone.
Inactive Ingredients: Lactose, Magnesium Stearate, Pregelatinized
Starch, Sodium Lauryl
Sulfate and Sodium Starch Glycolate.
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, cause profound and varied metabolic effects. In
addition, they modify
the body’s immune responses to diverse stimuli.
INDICATIONS AND USAGE
Prednisone tablets 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).
21
26
5
applicable; in infancy mineralocorticoid supplementation is of
particular importance).
Congenital adrenal hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
_2. Rheumatic Disorders_
As adjunctive therapy for short-term administration (to tide the
patient over