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:

American Health Packaging

INN（国际名称）:

PREDNISONE

组成:

PREDNISONE 5 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis - Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis - 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 - 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 - Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Aspiration pneumonitis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy - Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia - Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood - 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 - Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis - 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 are available in the following strengths and package sizes: 5 mg (white, round, scored, debossed “5094” on one side and debossed “V” on the reverse side) 10 mg (white, round, scored, debossed “5093” on one side and debossed “V” on the reverse side) 20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

授权状态:

Abbreviated New Drug Application

产品特点

PREDNISONE- PREDNISONE TABLET
AMERICAN HEALTH PACKAGING
----------
PREDNISONE TABLETS, USP
8416621/0623
RX ONLY
DESCRIPTION
PredniSONE Tablets contain prednisone which 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,
chloroform, dioxane, and methanol.
The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione
monohydrate,
17,21-dihydroxy-. The structural formula is represented below:
PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg,
10 mg and 20 mg.
_Inactive ingredients:_ 1 mg — colloidal silicon dioxide, lactose
monohydrate, magnesium
stearate, pregelatinized starch, sodium starch glycolate; 2.5 mg —
colloidal silicon
dioxide, lactose monohydrate, magnesium stearate, pregelatinized
starch, sodium
starch glycolate; 5 mg — colloidal silicon dioxide, lactose
monohydrate, magnesium
stearate, pregelatinized starch, sodium starch glycolate; 10 mg —
colloidal silicon
dioxide, lactose monohydrate, magnesium stearate, pregelatinized
starch, sodium
starch glycolate; 20 mg — FD&C Yellow #6 Lake, lactose monohydrate,
magnesium
stearate, microcrystalline cellulose, 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 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
firs