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:

Seton Pharmaceuticals, LLC

INN (International Name):

PREDNISOLONE SODIUM PHOSPHATE

Composition:

PREDNISOLONE 5 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Prednisolone Sodium Phosphate Oral Solution is indicated in the following conditions: 1. Allergic States 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. 2. Dermatologic Diseases Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3. Edematous States 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. 4. Endocrine Disorders 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 su

Product summary:

Prednisolone Sodium Phosphate Oral Solution is a colorless to light straw-colored, raspberry flavored solution containing 6.7 mg prednisolone sodium phosphate (5 mg prednisolone base) per 5 mL (teaspoonful). NDC 13925-166-04 120 mL bottle Store at 4°-25°C (39°-77°F). May be refrigerated. Keep tightly closed and out of the reach of children. Manufactured for: Seton Pharmaceuticals Manasquan, NJ 08736 Rev. 06/13

Authorization status:

New Drug Application

Summary of Product characteristics

PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM
PHOSPHATE SOLUTION
SETON PHARMACEUTICALS, LLC
----------
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. Prednisolone
Sodium Phosphate Oral
Solution also contains dibasic sodium phosphate, edetate disodium,
methylparaben,
purified water, sodium biphosphate, sorbitol,
natural and artificial raspberry flavor.
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,(11()-. 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.
21
27
2
8
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
glycogen in the li