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:

Proficient Rx LP

INN (International Name):

Prednisolone Sodium Phosphate

Composition:

Prednisolone 15 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL) is indicated in the following conditions: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. To induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephrotic syndrome, without uremia. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital ad

Product summary:

Each 5 mL (teaspoonful) of pale to light yellow, grape flavored solution contains 20.2 mg Prednisolone sodium phosphate (15 mg Prednisolone base). NDC 63187-215-64 (240 mL) bottle Dispense in tight, light-resistant glass or PET plastic containers as defined in the USP. Store at 2° to 25°C (36° to 77°F). May be refrigerated. Keep tightly closed and out of the reach of children. Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R06/09 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM PHOSPHATE SOLUTION
PROFICIENT RX LP
----------
PREDNISOLONE SODIUM PHOSPHATE
ORAL SOLUTION
(15 MG PREDNISOLONE BASE PER 5 ML)
RX ONLY
DESCRIPTION
Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5
mL) is a dye free, pale to
light 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 (15
mg Prednisolone per 5 mL)
contains the following inactive ingredients: anti-bitter mask, corn
syrup, edetate disodium, glycerin,
grape flavor, hydroxyethylcellulose, methylparaben, potassium
phosphate dibasic, potassium phosphate
monobasic, purified water, and sodium saccharin.
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
p