PREDNISONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Unit Dose Services

INN (International Name):

PREDNISONE

Composition:

PREDNISONE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Prednisone tablets are indicated in the following conditions: - 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 Endocrine 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 Rheumatic disorders - During an exacerbation or as maintenance therapy in selected ca

Product summary:

NDC:50436-4325-1 in a BOTTLE of 30 TABLETS NDC:50436-4325-2 in a BOTTLE of 21 TABLETS

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PREDNISONE- PREDNISONE TABLET
UNIT DOSE SERVICES
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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.
anhydrous lactose, corn starch, lactose monohydrate, magnesium
stearate, microcrystalline cellulose,
sodium starch glycolate.| anhydrous lactose, colloidal silicon
dioxide, magnesium stearate,
microcrystalline cellulose, sodium starch glycolate, and talc.
anhydrous lactose, colloidal silicon
dioxide, magnesium stearate, microcrystalline cellulose, sodium starch
glycolate, and talc. anhydrous
lactose, colloidal silicon dioxide, magnesium stearate,
microcrystalline cellulose, sodium starch
glycolate, and talc. anhydrous lactose, D&C Yellow No. 10 Aluminum
Lake, FD&C Yellow No. 6
Aluminum Lake, magnesium stearate, microcrystalline cellulose, and
sodium starch glycolate. _Inactive_
_ingredients: _
1 MG:
2.5 MG:
5 MG:
10 MG:
20 MG:
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.
21265
INDICATIONS AND