PREDNISOLONE SODIUM PHOSPHATE solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Cardinal Health

DCI (Dénomination commune internationale):

PREDNISOLONE SODIUM PHOSPHATE

Composition:

PREDNISOLONE 15 mg in 5 mL

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM PHOSPHATE SOLUTION
CARDINAL HEALTH
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PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION,
15 MG/5 ML
RX ONLY
DESCRIPTION
Prednisolone Sodium Phosphate Oral Solution is a dye free, pale yellow
solution. Each 5 mL
(teaspoonful) of prednisolone sodium phosphate oral solution contains
20.2 mg prednisolone sodium
phosphate (15 mg prednisolone base) in a palatable, aqueous vehicle.
Inactive Ingredients: Prednisolone Sodium Phosphate Oral Solution
equivalent to 15 mg prednisolone
per 5 mL contains the following inactive ingredients: alcohol 1.8%,
dibasic sodium phosphate, glycerin,
liquid sugar, monobasic sodium phosphate, natural and artificial grape
flavor, purified water, sodium
benzoate and sorbitol solution. It may contain 10% dibasic sodium
phosphate solution and/or 10%
monobasic sodium phosphate solution to adjust pH between 6.0 and 8.0.
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 chloroform; and very
slightly soluble in acetone and in dioxane.
The chemical name of prednisolone sodium phosphate is
11β,17,21-Trihydroxypregna- 1,4-diene-3,20-
dione 21-(disodium phosphate).
The molecular formula is C
H Na O P; the molecular weight is 484.39. Its chemical structure is:
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 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