PREDNISOLONE SODIUM PHOSPHATE solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Preferred Pharmaceuticals, Inc.

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Prednisolone sodium phosphate oral solution 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 adrenal hyperplasia; hypercalcem

Resumo do produto:

Prednisolone Sodium Phosphate Oral Solution   is a pale to light yellow, grape flavored solution containing 20.2 mg prednisolone sodium phosphate (15 mg prednisolone base) per 5 mL (teaspoonful) available in the following: 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.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM
PHOSPHATE SOLUTION
PREFERRED PHARMACEUTICALS, INC.
----------
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION
(15 MG PREDNISOLONE BASE PER 5 ML)
RX ONLY
DESCRIPTION
Prednisolone Sodium Phosphate Oral Solution 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
equivalent to 15 mg
prednisolone per 5 mL contains the following inactive ingredients:
anti-bitter mask,
edetate disodium, glycerin, grape flavor, high fructose corn syrup,
hydroxyethylcellulose, methylparaben, potassium phosphate dibasic,
potassium
phosphate monobasic, purified water, and saccharin sodium.
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.
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 dos