PREDNISONE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Proficient Rx LP

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: 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

Resumen del producto:

Prednisone Tablets, USP are available in the following strengths and package sizes: 10 mg (white, round, scored, imprinted with TL173) Repackaged in bottles of: 5, 6, 8, 9, 10, 12, 15, 18, 20, 21, 24, 27, 28, 36, 40 and 42. Store at 20° to 25° C (68° to 77° F) [See USP Room Temperature]. Manufactured By: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Revised 03/11

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

PREDNISONE- PREDNISONE TABLET
PROFICIENT RX LP
----------
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 juvenile rheum