PREDNISONE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Prednisone tablets 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 Hypercalcemia associated with cancer 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

leaflet_short:

PredniSONE Tablets, USP are available in the following strengths and package sizes: 20 mg (white, round, scored, imprinted PD02) Bottles of 5 NDC 70934-471-05 Bottles of 10 NDC 70934-471-10 Bottles of 12 NDC 70934-471-12 Bottles of 15 NDC 70934-471-15 Bottles of 18 NDC 70934-471-18 Bottles of 20 NDC 70934-471-20 Bottles of 21 NDC 70934-471-21 Bottles of 30 NDC 70934-471-30 Bottles of 40 NDC 70934-471-40 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM MOISTURE. Dispense in a tight, children-resistant container as defined in the USP/NF.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

PREDNISONE- PREDNISONE TABLET
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
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PREDNISONE TABLETS, USP
DESCRIPTION
Prednisone tablets contain prednisone which 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-
and its molecular weight is 358.43.
The structural formula is represented below:
Prednisone tablets are available in 3 strengths:10 mg, 20 mg and 50
mg. Inactive
ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Cellulose
Powder, Magnesium
Stearate, and Croscarmellose Sodium.
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
Prednisone tablets 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
Hypercalcemia associated with cancer
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