PREDNISONE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

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Download 제품 특성 요약 (SPC)
15-03-2017

유효 성분:

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

제공처:

Cambridge Therapeutics Technologies, LLC

INN (국제 이름):

PREDNISONE

구성:

PREDNISONE 5 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Prednisone Tablets, USP 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 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 Synovitis of osteoarthritis Epicondylitis. 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic derznatomyositis

제품 요약:

Prednisone Tablets, USP are available in the following strengths and package sizes: 5 mg (white, round, scored, imprinted with TL172)           NDC 70882-117-21, Package of 21 tablets (1 x 21 unit-of-dose blister)           NDC 70882-117-30, Adherence Packages of 30 Tablets Store at 20° to 25° C (68° to 77° F) [See USP Room Temperature]. Manufactured by Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. Distributed by Cambridge Therapeutic Technologies, LLC Teaneck, NJ 07666 Packaged by Legacy Pharmaceutical Packaging, LLC Earth City, MO 63045 Revised 02/2017 20555-1

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

                                PREDNISONE- PREDNISONE TABLET
CAMBRIDGE THERAPEUTICS TECHNOLOGIES, LLC
----------
PREDNISONE TABLETS, USP
RX ONLY
DESCRIPTION
Prednisone 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-
The structural formula is represented below:
Molecular weight: 358.44
Prednisone Tablets, USP are available in three strengths: 5 mg. In
addition, each tablet contains the
following Inactive Ingredients: Lactose Monohydrate, Magnesium
Stearate, Pregelatinized Starch,
Sodium Lauryl Sulfate and Sodium Starch Glycolate.
ACTIONS
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.
ACTION
ACTIONS
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-retaining
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
Prednisone Tablets, USP are indicated in the following conditions:
1. ENDOCRINE DISORDERS
Primary or secondary adrenocortical insufficiency (hyd
                                
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