PREDNISONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

McKesson Corporation dba SKY Packaging

INN (International Name):

PREDNISONE

Composition:

PREDNISONE 20 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; hypercalcemia associated with cancer; nonsuppurative thyroiditis. 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 erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. De rmatologic Diseases Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory Diseases Symptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic Diseases For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement. Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components.

Product summary:

Prednisone tablets, USP 20 mg are scored, round, peach tablets imprinted “DAN DAN” and “5443” Boxes of 10x10 UD 100, NDC 63739-588-10 Dispense in a well-closed container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Blisters: Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PREDNISONE- PREDNISONE TABLET
MCKESSON CORPORATION DBA SKY PACKAGING
----------
PREDNISONE TABLETS, USP
REVISED: OCTOBER 2015
RX ONLY
DESCRIPTION
Prednisone tablets, USP contain prednisone which is a glucocorticoid.
Glucocorticoids
are adrenocortical steroids, both naturally occurring and synthetic,
which are readily
absorbed from the gastrointestinal tract. The chemical name for
prednisone is pregna-
1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural
formula is
represented below:
C
H
O
M.W. 358.44
Prednisone is a white to practically white, odorless, crystalline
powder. It is very slightly
soluble in water; slightly soluble in alcohol, chloroform, dioxane,
and methanol.
Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of
prednisone, USP
(anhydrous). In addition, each tablet contains the following inactive
ingredients:
anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate
sodium, magnesium
stearate and sodium benzoate.
Prednisone tablets, USP 20 mg also contain FD&C Yellow No. 6.
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 cause profound and varied metabolic effects. In
addition, they modify
the body’s immune responses to diverse stimuli.
INDICATIONS AND USAGE
21
26
5
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; hypercalcemia associated with cancer;
nonsuppurative
thyroiditis.
RHEUMATIC DISORDERS
As adjunctive therapy for short-term admi