PREDNISOLONE SODIUM PHOSPHATE solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Seton Pharmaceuticals

INN (Kansainvälinen yleisnimi):

PREDNISOLONE SODIUM PHOSPHATE

Koostumus:

PREDNISOLONE 5 mg in 5 mL

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM PHOSPHATE SOLUTION
SETON PHARMACEUTICALS
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PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION
RX ONLY
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.
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 prope