PREDNISONE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Actavis Pharma, Inc.

Designación común internacional (DCI):

PREDNISONE

Composición:

PREDNISONE 5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Prednisone tablets, USP 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

Resumen del producto:

Prednisone tablets, USP 5 mg are scored, round, white tablets imprinted “DAN DAN ” and “5052 ” supplied in bottles of 100 and 1000 and blisters of 21 and 48. Prednisone tablets, USP 10 mg are scored, round, white tablets imprinted “DAN DAN ” and “5442 ” supplied in bottles of 100, 500 and 1000 and blisters of 21 and 48. Prednisone tablets, USP 20 mg are scored, round, peach tablets imprinted “DAN DAN ” and “5443 ” supplied in bottles of 100, 500 and 1000 and blisters of 21 and 48. Dispense in a well-closed container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Blisters: Protect from light and moisture.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

PREDNISONE- PREDNISONE TABLET
ACTAVIS PHARMA, INC.
----------
PREDNISONE TABLETS, USP
REVISED: OCTOBER 2015
RX ONLY
DESCRIPTION
Prednisone tablets, USP contain prednisone which is a glucocorticoid.
Glucocorticoids are
adrenocortical steroids, both naturally occurring and synthetic, which
are readily absorbed from the
gastrointestinal tract. The chemical name for prednisone is
pregna-1,4-diene-3,11,20-trione
monohydrate, 17,21-dihydroxy-. The structural formula is represented
below:
C
H O M.W. 358.44
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.
Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of
prednisone, USP (anhydrous). In
addition, each tablet contains the following inactive ingredients:
anhydrous lactose, colloidal silicon
dioxide, crospovidone, docusate sodium, magnesium stearate and sodium
benzoate.
Prednisone tablets, USP 20 mg also contain FD&C Yellow No. 6.
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, USP are indicated in the following conditions:
ENDOCRINE DISORDERS
21
26
5
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