PREDNISONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Direct_Rx

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 erythematosu

Product summary:

PredniSONE Tablets USP 10 mg, White to off white color, circular, biconvex tablets debossed with "P10" on one side and break line on other side and free from physical defects.. 20 mg, White to off white color, circular, biconvex tablets debossed with "P20" on one side and break line on other side free from physical defects. 50 mg, White to off white colour, biconvex round shaped tablet debossed with "P50" on one side, score on other side and free from physical defects. Product Name NDC Number Pack Type Prednisone Tablets USP, 10 mg 64380-784-01 10 x 10's Unit-Dose blister pack 64380-784-06 100's count in HDPE container 64380-784-07 500's count in HDPE container 64380-784-08 1000's count in HDPE container Prednisone Tablets USP, 20 mg 64380-785-01 10 x 10's Unit-Dose blister pack 64380-785-06 100's count in HDPE container 64380-785-07 500's count in HDPE container 64380-785-08 1000's count in HDPE container Prednisone Tablets USP, 50 mg 72189-489-07 7's Count in HDPE container 64380-949-01 10 x 10's count blister pack

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PREDNISONE- PREDNISONE TABLET
DIRECT_RX
----------
PREDNISONE
Each tablet for oral administration contains:
Prednisone, USP.................................................. 10
mg, 20 mg and 50 mg
Inactive Ingredients
The tablets contain lactose monohydrate, microcrystalline cellulose,
pregelatinized starch
(maize starch), sodium starch glycolate and magnesium stearate.
Prednisone tablets USP contain prednisone USP, 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:
[Structure]
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.
FDA approved dissolution test specifications differ from USP.
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.
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, i