PREDNISONE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Cardinal Health 107, LLC

DCI (Dénomination commune internationale):

PREDNISONE

Composition:

PREDNISONE 1 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

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. Available: Overbagged with 10 tablets per bag, NDC 55154-4938-0 10 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 899” debossed on the other side. Available: Overbagged with 10 tablets per bag, NDC 55154-4949-0 20 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 760” debossed on the other side. Available: Overbagged with 10 tablets per bag, NDC 55154-4946-0 50 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 343” debossed on the other side. Available: Overbagged with 10 tablets per bag, NDC 55154-4950-0 Distr. by: Hikma Pharmaceuticals USA Inc. Eatontown, NJ 07724 C50000278/03 Distributed By: Cardinal Health Dublin, OH 43017 L29830700321 L36704111021 L36155720821 L36704290221 Revised December 2020

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

PREDNISONE- PREDNISONE TABLET
CARDINAL HEALTH 107, LLC
----------
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.
C
H
O M.W. 358.44
21
26
5
_TM_
_Inactive Ingredients:_
PredniSONE Tablets, USP contain the following inactive ingredients:
lactose
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
add