PREDNISONE tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

即購入

ダウンロード 製品の特徴 (SPC)
12-10-2020

有効成分:

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

から入手可能:

Bryant Ranch Prepack

INN(国際名):

PREDNISONE

構図:

PREDNISONE 50 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Prednisone tablets and solutions 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), acut

製品概要:

Product: 63629-6660 NDC: 63629-6660-1 5 TABLET in a BOTTLE Product: 63629-7388 NDC: 63629-7388-1 20 TABLET in a BOTTLE

認証ステータス:

Abbreviated New Drug Application

製品の特徴

                                PREDNISONE- PREDNISONE TABLET
BRYANT RANCH PREPACK
----------
PREDNISONE TABLETS USP
PREDNISONE ORAL SOLUTION USP
PREDNISONE _INTENSOL_™ ORAL SOLUTION (CONCENTRATE)
RX ONLY
DESCRIPTION
Prednisone Tablets USP are available for oral administration
containing either 1 mg, 2.5 mg, 5 mg, 10
mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the
following inactive ingredients: lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
pregelatinized starch, sodium starch
glycolate and stearic acid (1 mg, 2.5 mg, and 5 mg only).
Prednisone Oral Solution USP is formulated for oral administration
containing 5 mg per 5 mL of
prednisone USP and alcohol 5%. The oral solution contains the
following inactive ingredients:
anhydrous citric acid, edetate disodium, fructose, hydrochloric acid,
maltol, peppermint oil,
polysorbate 80, propylene glycol, saccharin sodium, sodium benzoate,
vanilla flavor and purified water.
Prednisone _Intensol™_ Oral Solution (Concentrate) is formulated for
oral administration containing 5 mg
per mL of prednisone USP and alcohol 30%. In addition, the oral
solution contains the following
inactive ingredients: anhydrous citric acid, poloxamer 188, propylene
glycol and purified water.
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. The chemical name for prednisone is
17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The
structural formula is represented below:
Prednisone USP is a white to partially white, 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 m
                                
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