PREDNISONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT Rx USA LLC

INN (International Name):

PREDNISONE

Composition:

PREDNISONE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 lupu

Product summary:

      Prednisone Tablets, USP 5 mg: White, Round Tablets; Debossed “West-ward 475” on one side and Scored on the other side. Each tablet contains 5 mg of prednisone for oral administration.     Bottles of 21  -  NDC 16590-373-21     Bottles of 30  -  NDC 16590-373-30     Bottles of 48  -  NDC 16590-373-48     Bottles of 60  -  NDC 16590-373-60     Bottles of 90  -  NDC 16590-373-90     Bottles of 10  -  NDC 16590-326-10     Bottles of 15  -  NDC 16590-326-15     Bottles of 20  -  NDC 16590-326-20     Bottles of 21  -  NDC 16590-326-21     Bottles of 30  -  NDC 16590-326-30 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. Rx only Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised November 2010

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PREDNISONE - PREDNISONE TABLET
STAT RX USA LLC
REFERENCE LABEL SET ID: 39AC9B94-CF47-4ADE-8BB6-0E4347B974AB
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PREDNISONE TABLETS, USP
REV. 11/10
DESCRIPTION
Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical
steroids, both naturally occurring
and synthetic, which are readily absorbed from the gastrointestinal
tract. The molecular 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
358.44. 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 1 mg, 2.5 mg, 5 mg, 10 mg, or 20 mg of prednisone.
_Inactive ingredients:_
1 MG: anhydrous lactose, corn starch, lactose monohydrate, magnesium
stearate, microcrystalline
cellulose, sodium starch glycolate.|
2.5 MG: anhydrous lactose, colloidal silicon dioxide, magnesium
stearate, microcrystalline cellulose,
sodium starch glycolate, and talc.
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.
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, such as prednisone, cause profound and varied
metabolic effects. In addition, they
modify the body's imm