PREDNISONE- prednisone tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Prednisone (UNII: VB0R961HZT) (Prednisone - UNII:VB0R961HZT)

Commercializzato da:

Quality Care Products LLC

INN (Nome Internazionale):

Prednisone

Composizione:

Prednisone 5 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 (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 Systemic fungal infections and known hypersensitivity to components.

Dettagli prodotto:

PREDNISONE 5MG 55700-209 WHITE, ROUND, SCORED, INPRINTED WITH TL 172 PREDNISONE 10MG 55700-208 WHITE, ROUND, SCORED, IMPRINTED WITH TL 173 PREDNISONE 20MG 55700-203 PEACH, ROUND, SCORED, IMPRINTED WITH TL 175

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PREDNISONE - PREDNISONE TABLET
QUALITY CARE PRODUCTS LLC
----------
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 juve