PREDNISONE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Compra

Scarica Scheda tecnica (SPC)
20-03-2015

Principio attivo:

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

Commercializzato da:

Blenheim Pharmacal, Inc.

INN (Nome Internazionale):

PREDNISONE

Composizione:

PREDNISONE 10 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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; hypercalcemia associated with cancer; nonsuppurative thyroiditis. 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 erythemato

Dettagli prodotto:

Prednisone Tablets USP 5 mg are scored, round, white tablets imprinted DAN DAN and 5052 supplied in bottles of 100 and 1000. Prednisone Tablets USP 10 mg are scored, round, white tablets imprinted DAN DAN and 5442 supplied in bottles of 100, 500 and 1000. Prednisone Tablets USP 20 mg are scored, round, peach tablets imprinted DAN DAN and 5443 supplied in bottles of 100, 500 and 1000. Dispense in a well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

                                PREDNISONE- PREDNISONE TABLET
BLENHEIM PHARMACAL, INC.
----------
PREDNISONE TABLETS USP
REVISED: SEPTEMBER 2008
RX ONLY 173666
RX ONLY
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 antiinflammatory 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:
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; hypercalcemia associated with cancer; nonsuppurative
thyroiditis.
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 trea
                                
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