PREDNISONE- prednisone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceutical

INN (International Name):

PREDNISONE

Composition:

PREDNISONE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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

Product summary:

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.     Bottles of 100 tablets     Bottles of 1000 tablets 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.     Bottles of 100 tablets     Bottles of 1000 tablets Prednisone Tablets, USP 20 mg: Peach, Round Tablets, Debossed “West-ward 477” one one side and Scored on the other side. Each tablet contains 20 mg of prednisone for oral administration. Bottles of 100 tablets Bottles of 500 tablets Bottles of 1000 tablets 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: Hikma Pharmaceutical P.O Box 182400. Amman 11118-Jordan Distributed by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 USA Revised November 2011

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PREDNISONE- PREDNISONE TABLET
HIKMA PHARMACEUTICAL
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PREDNISONE TABLETS, USP
REV. 12/11
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 5 mg or 10 mg of prednisone.
_Inactive ingredients:_
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 immune responses to diverse stimuli.
INDICATIONS AND USAGE
Prednisone Tablets, USP are indicated in the following conditions:
ENDOCRINE DISORDERS
21
26
5
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