PREDNISONE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Bryant Ranch Prepack

INN (nemzetközi neve):

PREDNISONE

Összetétel:

PREDNISONE 50 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Prednisone tablets and solutions 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 car

Termék összefoglaló:

NDC: 63629-4562-1: 90 Tablets in a BOTTLE NDC: 63629-4562-2: 5 Tablets in a BOTTLE NDC: 63629-4562-3: 30 Tablets in a BOTTLE NDC: 63629-4562-4: 60 Tablets in a BOTTLE NDC: 63629-4562-5: 120 Tablets in a BOTTLE NDC: 63629-4562-6: 7 Tablets in a BOTTLE NDC: 63629-4562-7: 20 Tablets in a BOTTLE

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

PREDNISONE- PREDNISONE TABLET
BRYANT RANCH PREPACK
----------
PREDNISONE TABLETS, USP
PREDNISONE ORAL SOLUTION, USP
PREDNISONE _INTENSOL_™ ORAL SOLUTION (CONCENTRATE)
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, USP is a white to partially white, crystalline
powder. It is very slightly
soluble in water; slightly soluble in alcohol, chloroform, dioxane,
and methanol.
The chemical name for prednisone is
17,21-dihydroxypregna-1,4-dienne-3,11,20-trione.
The structural formula is represented below:
Each tablet, for oral administration, contains 1, 2.5, 5, 10, 20, or
50 mg of prednisone.
PredniSONE Oral Solution contains 5 mg prednisone per 5 mL, and
PredniSONE
_Intensol_
Oral Solution [Concentrate] contains 5 mg prednisone per mL.
_Inactive Ingredients:_
PredniSONE Tablets, USP contain the following inactive ingredients:
lactose
C
H
O M.W. 358.44
21
26
5
_TM_
monohydrate, magnesium stearate, microcrystalline cellulose,
pregelatinized starch,
sodium starch glycolate and stearic acid (1 mg, 2.5 mg, and 5 mg
only).
PredniSONE Oral Solution, USP contains alcohol 5% and the following
inactive
ingredients: anhydrous citric acid, edetate disodium, fructose,
hydrochloric acid, maltol,
peppermint oil, polysorbate 80, propylene glycol, saccharin sodium,
sodium benzoate,
vanilla flavor and purified water.
PredniSONE _Intensol™_ Oral Solution (Concentrate) contains alcohol
30% and the
following inactive ingredients: anhydrous citric acid, poloxamer 188,
propylene glycol
and purified water.
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
additio