PREDNISONE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

H. J. Harkins Company Inc.

INN (국제 이름):

PREDNISONE

구성:

PREDNISONE 5 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

PredniSONE Tablets 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 Nonsuppurative thyroiditis Hypercalcemia associated with cancer 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 sel

제품 요약:

PredniSONE Tablets are available in the following strengths and package sizes: 5 mg (white, round, scored, debossed “5094” on one side and debossed “V” on the reverse side) Bottles of 100 NDC 0603-5337-21 Bottles of 500 NDC 0603-5337-28 Bottles of 1000 NDC 0603-5337-32 Unit-of-Use (21 Tablets) NDC 0603-5337-15 Unit-of-Use (48 Tablets) NDC 0603-5337-31 Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

PREDNISONE- PREDNISONE TABLET
H. J. HARKINS COMPANY INC.
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DES CRIPTION
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. 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.
The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione
monohydrate,17,21-dihydroxy-.
The structural formula is represented below:
[This is an image of the formula for PredniSONE.]
PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg,
10 mg and 20 mg.
Inactive ingredients: 1 mg — lactose monohydrate, magnesium
stearate, microcrystalline cellulose,
pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg
— lactose monohydrate, magnesium
stearate, microcrystalline cellulose, pregelatinized starch, sodium
starch glycolate, stearic acid; 5 mg—
colloidal silicon dioxide, lactose monohydrate, magnesium stearate,
pregelatinized starch, sodium
starch glycolate; 10 mg—colloidal silicon dioxide, lactose
monohydrate, magnesium stearate,
pregelatinized starch, sodium starch glycolate; 20 mg—FD&C Yellow #6
Lake, lactose monohydrate,
magnesium stearate, microcrystalline cellulose, sodium starch
glycolate.
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 & USAGE
PredniSONE Tablets are indicated in the following conditions:
Endocrine Disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone o