PREDNISONE tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Apotheca Inc.

INN（国際名）:

PREDNISONE

構図:

PREDNISONE 5 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Prednisone Tablets, USP are indicated in the following conditions: 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. 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. During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumat

製品概要:

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. NDC 12634-184-00 Bottles of 10 NDC 12634-184-01 Bottles of 100 NDC 12634-184-09 Bottles of 35 NDC 12634-184-40 Bottles of 40 NDC 12634-184-42 Bottles of 42 NDC 12634-184-50 Bottles of 50 NDC 12634-184-52 Blister Pack of 12 NDC 12634-184-54 Blister Pack of 14 NDC 12634-184-57 Blister Pack of 20 NDC 12634-184-59 Blister Pack of 30 NDC 12634-184-60 Bottles of 60 NDC 12634-184-61 Blister Pack of 10 NDC 12634-184-63 Blister Pack of 3 NDC 12634-184-66 Blister Pack of 6 NDC 12634-184-67 Blister Pack of 7 NDC 12634-184-69 Blister Pack of 9 NDC 12634-184-71 Bottles of 30 NDC 12634-184-74 Bottles of 24 NDC 12634-184-78 Bottles of 28 NDC 12634-184-79 Bottles of 25 NDC 12634-184-80 Bottles of 20 NDC 12634-184-81 Bottles of 21 NDC 12634-184-82 Bottles of 12 NDC 12634-184-85 Bottles of 15 NDC 12634-184-91 Blister pack of 1 NDC 12634-184-94 Bottles of 4 NDC 12634-184-95 Bottles of 5 NDC 12634-184-96 Bottles of 6 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.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

PREDNISONE- PREDNISONE TABLET
APOTHECA INC.
----------
PREDNISONE TABLETS 5 MG
PREDNISONE TABLETS, USP
RX ONLY
DESCRIPTION
Each tablet for oral administration contains:
Prednisone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . 2.5 mg, 5 mg, 10 mg, 20 mg
INACTIVE INGREDIENTS
Prednisone Tablets, USP of 2.5 mg, 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:
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
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, 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 supplementati