PREDNISONE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Dispensing Solutions, Inc.

Designación común internacional (DCI):

PREDNISONE

Composición:

PREDNISONE 2.5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Prednisone tablets and solutions are indicated in the following conditions: 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. 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. During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acut

Resumen del producto:

PredniSONE Tablets USP 2.5 mg, round, white, scored tablets (Identified 54 339) NDC 66336-0219-30 Bottles of 30 tablets. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Discard opened bottle after 90 days.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

PREDNISONE- PREDNISONE TABLET
DISPENSING SOLUTIONS, INC.
----------
PREDNISONE TABLETS USP, 1 MG, 2.5 MG, 5 MG, 10 MG, 20 MG, AND 50 MG,
PREDNISONE ORAL SOLUTION USP, 5 MG PER 5 ML AND
PREDNISONE INTENSOL™ ORAL SOLUTION (CONCENTRATE), 5 MG PER ML
RX ONLY
DESCRIPTION
Each tablet for oral administration contains:
Prednisone.............................................................2.5
mg
INACTIVE INGREDIENTS
The tablets contain lactose monohydrate, magnesium stearate,
microcrystalline cellulose, pregelatinized
starch and sodium starch glycolate. In addition, the 1 mg tablets also
contain stearic acid.
Prednisone Oral Solution contains alcohol, citric acid, disodium
edetate, fructose, hydrochloric acid,
maltol, peppermint oil, polysorbate 80, propylene glycol, saccharin
sodium, sodium benzoate, vanilla
flavor and water.
Prednisone Intensol contains alcohol, citric acid, poloxamer 188,
propylene glycol and water.
Prednisone tablets 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. 358.43
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.
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
21
26
5
Prednisone tablets and solutions are indicated in the following
conditions:
ENDOCRI