PREDNISONE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Direct_Rx

INN (Tarptautinis Pavadinimas):

PREDNISONE

Sudėtis:

PREDNISONE 20 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 erythematosus

Produkto santrauka:

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.]

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

PREDNISONE- PREDNISONE TABLET
DIRECT_RX
----------
PREDNISONE
DESCRIPTION SECTION
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:
C21H26O5 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 SECTION
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 & USAGE SECTION
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 exacerbat