PREDNISONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aidarex Pharmaceuticals LLC

INN (International Name):

PREDNISONE

Composition:

PREDNISONE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Prednisone Tablets, USP are indicated in the following conditions: 1. 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 2. 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. 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic derznatomyositis

Product summary:

Prednisone Tablets, USP are available in the following strengths and package sizes: 10 mg (white, round, scored, imprinted with TL173) Store at 20° to 25° C (68° to 77° F) [See USP Room Temperature]. Repackaged by Aidarex Pharmaceuticals, LLC Corona, CA 92880

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PREDNISONE- PREDNISONE TABLET
AIDAREX PHARMACEUTICALS LLC
----------
PREDNISONE TABLETS, USP
RX ONLY
DESCRIPTION
Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical
steroids, both naturally occurring
and synthetic, which are readily absorbed from the gastrointestinal
tract. Prednisone is a white to
practically white, odorless, crystalline powder. It is very slightly
soluble in water; slightly soluble in
alcohol, in chloroform, in dioxane, and in methanol. The chemical name
for prednisone is pregna-1, 4-
diene-3, 11, 20-trione, 17, 21-dihydroxy-
The structural formula is represented below:
Molecular weight: 358.44
Prednisone Tablets, USP are available in three strengths: 5 mg, 10 mg,
and 20 mg. In addition, each
tablet contains the following Inactive Ingredients: Lactose
Monohydrate, Magnesium Stearate,
Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch
Glycolate. Also Prednisone Tablets
USP, 20 mg contains FD & C yellow #6 aluminum lake HT 15-18%.
ACTIONS
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 cause profound and varied metabolic effects. In
addition, they modify the body's
immune responses to diverse stimuli.
INDICATIONS
Prednisone Tablets, USP are indicated in the following conditions:
1. 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
2. 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 juv