PREDNISONE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Keltman Pharmaceuticals Inc.

INN (Algemene Internationale Benaming):

PREDNISONE

Samenstelling:

PREDNISONE 20 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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. 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

Product samenvatting:

Prednisone Tablets USP, 5 mg: White, round tablets, scored on one side and "West-ward 475" debossed on the other side. Each tablet contains 5 mg of prednisone for oral administration. Prednisone Tablets USP, 10 mg: White, round tablets, scored on one side and "West-ward 473" debossed on the other side. Each tablet contains 10 mg of prednisone for oral administration. Prednisone Tablets USP, 20 mg: Peach colored, round tablets, scored on one side and "Westward 477" debossed on the other side. Each tablet contains 20 mg of prednisone for oral administration. They are supplied by Keltman Pharmaceuticals Inc. as follows: Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: West-ward Pharmaceutical Corp. Eatontown. NJ 07724 This Product was Repackaged By Sandhills Packaging for: Keltman Pharmaceuticals Inc. 1 Lakeland Square, Suite A Flowood, MS 39232 United States

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

PREDNISONE - PREDNISONE TABLET
KELTMAN PHARMACEUTICALS INC.
----------
PREDNISONE TABLETS
RX ONLY
DESCRIPTION
Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical
steroids, both naturally occurring
and synthetic, that are readily absorbed from the gastrointestinal
tract. The formula for prednisone is
C
H O . Chemically, it is 17,21-dihydroxypregna-1, 4-diene-3,11,
20-trione and has the following
structural formula:
Prednisone is a white to practically white, odorless, crystalline
powder and has a molecular weight of
358.43. It melts at about 230°C with some decomposition. Prednisone
is very slightly soluble in water,
slightly soluble in alcohol, chloroform, dioxane, and methanol.
Each tablet, for oral administration, contains 5 mg, 10 mg, and 20 mg
prednisone.
Inactive ingredients are as follows:
CLINICAL PHARMACOLOGY
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-retaining
21
26
5
5 MG: anhydrous lactose, colloidal silicon dioxide, magnesium
stearate, microcrystalline
cellulose, sodium starch glycolate, and talc.
10 MG: anhydrous lactose, colloidal silicon dioxide, magnesium
stearate, microcrystalline
cellulose, sodium starch glycolate, and talc.
20 MG: anhydrous lactose, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow
No. 6 Aluminum
Lake, magnesium stearate, microcrystalline cellulose, and sodium
starch glycolate.
properties, are used as replacement therapy in adrenocortical
deficiency states. Their synthetic analogs,
such as prednisone, are primarily used for their potent
antiinflammatory effects in disorders of many
organ systems.
Glucocorticoids, such as prednisone, cause profound and varied
metabolic effects. In addition, they
modify the body's immune response to diverse stimuli.
INDICATIONS AND USAGE
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 whe