PREDNISONE tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

RedPharm Drug, Inc.

INN (Medzinárodný Name):

PREDNISONE

Zloženie:

PREDNISONE 20 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 lu

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

PREDNISONE- PREDNISONE TABLET
REDPHARM DRUG, INC.
----------
SPL UNCLASSIFIED SECTION
PREDNISONE TABLETS, USP
Rx Only
DESCRIPTION
Each tablet for oral administration contains:
Prednisone.................................................5 mg, 10 mg
and 20 mg
Inactive Ingredients
Prednisone Tablets, USP of 5 mg and 10 mg strengths contain anhydrous
lactose,
colloidal silicon dioxide, magnesium stearate, microcrystalline
cellulose, sodium starch
glycolate, and talc.
Prednisone Tablets, USP of 20 mg strength contain anhydrous lactose,
D&C Yellow No.
10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate,
microcrystalline cellulose and sodium starch glycolate.
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:
[structural formula]
C21H26O5 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
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 supplem