PREDNISONE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

PharmPak, Inc.

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 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. Bottle of 20         NDC 54348-506-20 Bottle of 10         NDC 54348-506-10 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
PHARMPAK, 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-
21
26
5
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
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