PREDNISONE tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

DIRECT RX

ИНН (Международная Имя):

PREDNISONE

состав:

PREDNISONE 20 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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 erythema

Обзор продуктов:

Prednisone Tablets, USP 5 mg: White, Round Tablets; Debossed “West-ward 475” on one side and Scored on the other side. Each tablet contains 5 mg of prednisone for oral administration. Bottles of 100 tablets Bottles of 1000 tablets Prednisone Tablets, USP 10 mg: White, Round Tablets; Debossed “WEST-WARD 473” on one side and Scored on the other side. Each tablet contains 10 mg of prednisone for oral administration. Bottles of 100 tablets Bottles of 1000 tablets Prednisone Tablets, USP 20 mg: Peach, Round Tablets; Debossed “West-ward 477” on one side and Scored on the other side. Each tablet contains 20 mg of prednisone for oral administration. Bottles of 100 tablets Bottles of 500 tablets Bottles of 1000 tablets Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

PREDNISONE- PREDNISONE TABLET
DIRECT RX
----------
PREDNISONE
DESCRIPTION
Each tablet for oral administration contains:
Prednisone.................................................5 mg, 10 mg
and 20 mg
Inactive Ingredients
Prednisone Tablets, USP of 5 mg and 10 mg strengths contain anhydrous
lactose, colloidal silicon
dioxide, magnesium stearate, microcrystalline cellulose, sodium starch
glycolate, and talc.
Prednisone Tablets, USP of 20 mg strength contain anhydrous lactose,
D&C Yellow No. 10
Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate,
microcrystalline
cellulose and sodium starch glycolate.
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:
C21H26O5 M.W. 358.43
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.
CLINICAL PHARMACOLOGY SECTION
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 SECTION
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 hyper