PREDNISONE tablet PREDNISONE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

NCS HealthCare of KY, LLC dba Vangard Labs

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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), acut

Resumen del producto:

PredniSONE Tablets USP 1 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 092” debossed on the other side. NDC 0615-8306-39: Blistercards of 30 Tablets 2.5 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 339” debossed on the other side. 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 0615-0536-05: Blistercards of 15 Tablets NDC 0615-0536-39: Blistercards of 30 Tablets NDC 0615-0536-30: 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. 20 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 760” debossed on the other side. 50 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 343” 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. PredniSONE Oral Solution USP, 5 mg per 5 mL Clear, colorless, slightly viscous solution. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF. PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL Clear, colorless, slightly viscous solution. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

PREDNISONE- PREDNISONE TABLET
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
----------
PREDNISONE TABLETS USP
PREDNISONE ORAL SOLUTION USP
PREDNISONE _INTENSOL_™ ORAL SOLUTION (CONCENTRATE)
RX ONLY
DESCRIPTION
Prednisone Tablets USP are available for oral administration
containing either 1 mg, 2.5
mg, 5 mg, 10 mg, 20 mg or 50 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
(1 mg, 2.5 mg, and 5 mg only).
Prednisone Oral Solution USP is formulated for oral administration
containing 5 mg per 5
mL of prednisone USP and alcohol 5%. The oral solution contains 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) is formulated for
oral administration
containing 5 mg per mL of prednisone USP and alcohol 30%. In addition,
the oral
solution contains the following inactive ingredients: anhydrous citric
acid, poloxamer
188, propylene glycol and purified water.
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
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
a