PREDNISONE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

RedPharm Drug Inc.

Designación común internacional (DCI):

PREDNISONE

Composición:

PREDNISONE 10 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

PredniSONE Tablets 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 Nonsuppurative thyroiditis Hypercalcemia associated with cancer 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 Hypercalcemia associated with cancer - 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 rheumat

Resumen del producto:

PredniSONE Tablets are available in the following strengths and package sizes: 1 mg (white, round, flat-faced, beveled edge, scored, debossed "5084" on one side and debossed "V" on the reverse side)      Bottles of 10, 100, 500, and 1000 2.5 mg (white, round, flat-faced, beveled edge, scored, debossed "5085" on one side and debossed "V" on the reverse side)      Bottles of 10, 100, 500, and 1000 5 mg (white, round, scored, debossed "5094" on one side and debossed "V" on the reverse side)      Bottles of 100, 500, and 1000     Unit-of-Use (21 and 48 tablets) 10 mg (white, round, scored, debossed "5093" on one side and debossed "V" on the reverse side)      Bottles of 100, 500, and 1000     Unit-of-Use (21 and 48 tablets) 20 mg (peach, round, scored, debossed "5092" on one side and debossed "V" on the reverse side)      Bottles of 100, 500, and 1000     Unit-of-Use (21 and 48 tablets) Dispense in a tight light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

PREDNISONE - PREDNISONE TABLET
REDPHARM DRUG INC.
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PREDNISONE TABLET
DESCRIPTION
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. 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- and its
molecular weight is 358.43.
The structural formula is represented below:
PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg,
10 mg and 20 mg.
_Inactive ingredients:_ 1 mg — lactose monohydrate, magnesium
stearate, microcrystalline cellulose,
pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg
— lactose monohydrate, magnesium
stearate, microcrystalline cellulose, pregelatinized starch, sodium
starch glycolate, stearic acid; 5 mg—
colloidal silicon dioxide, lactose monohydrate, magnesium stearate,
pregelatinized starch, sodium
starch glycolate; 10 mg—colloidal silicon dioxide, lactose
monohydrate, magnesium stearate,
pregelatinized starch, sodium starch glycolate; 20 mg—FD and C
Yellow No. 6 Lake, lactose
monohydrate, magnesium stearate, microcrystalline cellulose, sodium
starch glycolate.
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 are indicated in the following conditions:
1. ENDOCRINE DISORDERS
Primary or secondary adrenocortical insufficiency (hydrocort