PREDNISONE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Clinical Solutions Wholesale, LLC

Designación común internacional (DCI):

PREDNISONE

Composición:

PREDNISONE 10 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. 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
CLINICAL SOLUTIONS WHOLESALE, LLC
----------
PREDNISONE TABLETS, USP
REVISED: JULY 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.
21
26
5
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