PREDNISONE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Aphena Pharma Solutions - Tennessee, LLC

INN (Internationale Bezeichnung):

PREDNISONE

Zusammensetzung:

PREDNISONE 5 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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; 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 lupus erythemato

Produktbesonderheiten:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Prednisone Tablets USP 5 mg are scored, round, white tablets imprinted DAN DAN and 5052 supplied in bottles of 100 and 1000. Prednisone Tablets USP 10 mg are scored, round, white tablets imprinted DAN DAN and 5442 supplied in bottles of 100, 500 and 1000. Prednisone Tablets USP 20 mg are scored, round, peach tablets imprinted DAN DAN and 5443 supplied in bottles of 100, 500 and 1000. Dispense in a well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

PREDNISONE- PREDNISONE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
PREDNISONE TABLETS USP
REVISED: SEPTEMBER 2008
RX ONLY 173666
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. 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. 358.44
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.
Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of
prednisone USP (anhydrous). In
addition, each tablet contains the following inactive ingredients:
anhydrous lactose, colloidal silicon
dioxide, crospovidone, docusate sodium, magnesium stearate and sodium
benzoate.
Prednisone Tablets USP 20 mg also contain FD&C Yellow No. 6.
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 antiinflammatory 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:
21
26
5
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-ter