PREDNISONE- prednisone tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Preferred Pharmaceuticals Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

PredniSONE Tablets are indicated in the following conditions: Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components.

Dettagli prodotto:

PredniSONE Tablets are available in the following strengths and package sizes: 10 mg (white, round, scored, debossed “5093” on one side and debossed “V” on the reverse side) 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].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PREDNISONE- PREDNISONE TABLET
PREFERRED PHARMACEUTICALS INC.
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PREDNISONE TABLETS, USP
1 MG, 2.5 MG, 5 MG, 10 MG AND 20 MG
RX ONLY
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, chloroform, dioxane, and
methanol.
The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione
monohydrate,17,21-dihydroxy-.
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.
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.
2.
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
2.
3.
4.
5.
6.
7.
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 nonspe