PREDNISONE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

TYA Pharmaceuticals

INN (국제 이름):

PREDNISONE

구성:

PREDNISONE 10 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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. Endocrine 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. Rheumatic Disorders During an exacerbation or as maintenance therapy in selecte

제품 요약:

NDC:64725-1473-1 in a CONTAINER of 30 TABLETS

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

PREDNISONE- PREDNISONE TABLET
TYA PHARMACEUTICALS
----------
PREDNISONE TABLETS, USP
RX ONLY
DESCRIPTION
Each tablet for oral administration contains: Prednisone . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg
Prednisone Tablets, USP of 1 mg strength contain anhydrous lactose,
corn starch, lactose monohydrate,
magnesium stearate, microcrystalline cellulose and sodium starch
glycolate. 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:
Primary or secondary adrenocortical insufficiency (hydrocortisone or
cortisone is t