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:

Akorn

Designación común internacional (DCI):

PREDNISOLONE SODIUM PHOSPHATE

Composición:

PREDNISOLONE 5 mg in 5 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Prednisolone Sodium Phosphate Oral Solution is indicated in the following conditions: Systemic fungal infections. Hypersensitivity to the drug or any of its components.

Resumen del producto:

Prednisolone Sodium Phosphate Oral Solution is a colorless to light straw colored, raspberry flavored solution containing 6.7 mg prednisolone sodium phosphate (5 mg prednisolone base) per 5 mL (teaspoonful). NDC 50383-040-04 120 mL Bottle Store at 4° - 25°C (39° -77°F). May be refrigerated. Keep tightly closed and out of the reach of children. Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, N.Y. 11701 Rev. 040:04 7/16

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM
PHOSPHATE SOLUTION
AKORN
----------
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION
DESCRIPTION
Prednisolone Sodium Phosphate Oral Solution is a dye-free, colorless
to light straw-
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. In addition, each
5 mL Prednisolone
Sodium Phosphate Oral Solution contains the following inactive
ingredients: Disodium
Edetate, Methylparaben, Natural and Artificial Raspberry Flavor,
Purified Water, Sodium
Phosphate Dibasic Heptahydrate, Sodium Phosphate Monobasic
Monohydrate, and
Sorbitol.
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.
21
27
2
8
Prednisolone is a synthetic adrenocortical steroid drug with
predominantly glucocorticoid
properties. Some of these properties reproduce the physiological
actions of endogenous
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: