PREDNISOLONE SODIUM PHOSPHATE- prednisolone sodium phosphate solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

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Productkenmerken Productkenmerken (SPC)
11-12-2017

Werkstoffen:

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

Beschikbaar vanaf:

A-S Medication Solutions

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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

Product samenvatting:

Product: 50090-1411 NDC: 50090-1411-0 120 mL in a BOTTLE

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

                                PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM PHOSPHATE SOLUTION
A-S MEDICATION SOLUTIONS
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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.
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 i
                                
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