PREDNISONE tablet PREDNISONE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

NCS HealthCare of KY, LLC dba Vangard Labs

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Prednisone tablets 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 rheumatic ca

제품 요약:

PredniSONE Tablets USP 5 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 612” debossed on the other side. NDC 0615-8395-39: Blistercard of 30 Tablets NDC 0615-8395-05: Blistercard of 15 Tablets NDC 0615-8395-30: Unit-dose Boxes of 30 Tablets 10 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 899” debossed on the other side. NDC 0615-8391-39: Blistercard of 30 Tablets NDC 0615-8391-05: Blistercard of 15 Tablets NDC 0615-8391-30: Unit-dose Boxes of 30 Tablets 20 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 760” debossed on the other side. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, child-resistant container as defined in the USP/NF. PROTECT FROM MOISTURE.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

PREDNISONE- PREDNISONE TABLET
PREDNISONE- PREDNISONE TABLET
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
----------
PREDNISONE TABLETS USP
RX ONLY
DESCRIPTION
Prednisone Tablets USP are available for oral administration
containing either 5 mg, 10
mg, or 20 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 (5 mg only).
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:
C
H
O M.W. 358.44
Prednisone USP is a white to partially white, crystalline powder. It
is very slightly soluble
21
26
5
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 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; hypercalcemia associated with cancer;
nonsuppurative
thyroiditis.
RHEUMATIC DISORDERS
As adjunctive therapy for short-term administration (to tide the
patient over an acute
e