PEDIAPRED prednisolone sodium phosphate solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Royal Pharmaceuticals

INN (International Name):

PREDNISOLONE SODIUM PHOSPHATE

Composition:

PREDNISOLONE 5 mg in 5 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PEDIAPRED- PREDNISOLONE SODIUM PHOSPHATE SOLUTION
ROYAL PHARMACEUTICALS
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PEDIAPRED
(PREDNISOLONE SODIUM PHOSPHATE) ORAL SOLUTION
RX ONLY
DESCRIPTION
PEDIAPRED (prednisolone sodium phosphate) Oral Solution is a dye free,
colorless to light straw-
colored, raspberry flavored solution. Each 5 mL (teaspoonful) of
PEDIAPRED contains 6.7 mg
prednisolone sodium phosphate (5 mg prednisolone base) in a palatable,
aqueous vehicle. In addition,
each 5 mL PEDIAPRED 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.
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: promotion of
gluconeogenesis; increased
deposition of