PREDNISOLONE SODIUM PHOSPHATE solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

PREDNISOLONE SODIUM PHOSPHATE (UNII: IV021NXA9J) (PREDNISOLONE - UNII:9PHQ9Y1OLM)

Disponible desde:

Chartwell RX, LLC.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Prednisolone sodium phosphate oral solution is indicated in the following conditions: 1. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. 2. Dermatologic Diseases Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3. Edematous States To induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephrotic syndrome, without uremia. 4. 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 su

Resumen del producto:

Prednisolone sodium phosphate oral solution is a clear, colorless to light yellow-colored, raspberry flavored solution containing 6.7 mg prednisolone sodium phosphate (5 mg prednisolone base) per 5 mL (teaspoonful). NDC 62135-330-41: 120 mL bottle Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. May be refrigerated. Keep tightly closed and out of the reach of children. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 Made in USA L70328 Revised 06/2023

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM
PHOSPHATE SOLUTION
CHARTWELL RX, LLC.
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PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION
PREDNISOLONESODIUM PHOSPHATE ORAL SOLUTION
DESCRIPTION
Prednisolone sodium phosphate oral solution is a dye free, clear,
colorless to slightly
yellow colored, raspberry flavored solution. Each 5 mL (teaspoonful)
of
prednisolone sodium phosphate oral solution contains 6.7 mg
prednisolone sodium
phosphate (5 mg prednisolone base) in a palatable, aqueous vehicle.
Prednisolone sodium phosphate oral solution also contains edetate
disodium,
methylparaben, purified water, sodium phosphate dibasic, sodium
phosphate
monobasic, sorbitol solution, and artificial raspberry flavor.
Prednisolone sodium phosphate occurs as white or slightly yellow,
friable granules or
powder. It is freely soluble in water; soluble in methanol; slightly
soluble in alcohol and in
chloroform; and very slightly soluble in acetone and in dioxane. The
chemical name of
prednisolone sodium phosphate is: pregna-1,4-diene-3,20-dione,
11,17-dihydroxy-21-
(phosphonooxy)- disodium salt, (11β)-. The empirical formula is C
H
Na
O
P; the
molecular weight is 484.39.
Its chemical structure is:
Pharmacological Category: Glucocorticoid
CLINICAL PHARMACOLOGY
Naturally occurring glucocorticoids (hydrocortisone), 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.
Prednisolone is a synthetic adrenocortical steroid drug with
predominantly glucocorticoid
properties. Some of these properties reproduce the physiological
actions of endogenous
21
27
2
8
glucocorticosteroids, but others do not necessarily reflect any of the
adrenal hormones’
normal functions; they are seen only after administration of large
therapeutic doses of
the drug. The pharmacological effects of prednisolone which are due to
its
glucocorticoid properties include: promotion of gl