PREDNISONE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

MedVantx, 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 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 arthriti

제품 요약:

PredniSONE Tablets are available in the following strengths and package sizes: 1 mg (white, round, flat-faced, beveled edge, scored, debossed “5084” on one side and debossed “V” on the reverse side) 2.5 mg (white, round, flat-faced, beveled edge, scored, debossed “5085” on one side and debossed “V” on the reverse side) 5 mg (white, round, scored, debossed “5094” on one side and debossed “V” on the reverse side) 10 mg (white, round, scored, debossed “5093” on one side and debossed “V” on the reverse side) 20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side) 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
MEDVANTX, INC.
----------
PREDNISONE TABLETS, USP
1 MG, 2.5 MG, 5 MG, 10 MG AND 20 MG
RX ONLY
DESCRIPTION
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:
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 AND USAGE
PredniSONE Tablets are indicated in the following conditions:
1. ENDOCRINE DISORDERS
Primary or secondary adrenocortical insufficiency (hydr