VERIPRED 20- prednisolone sodium phosphate solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Cerecor, Inc.

Designación común internacional (DCI):

PREDNISOLONE SODIUM PHOSPHATE

Composición:

PREDNISOLONE 20 mg in 5 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

VERIPRED™ 20 (20 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 adrenal hyperplasia; hypercalcem

Resumen del producto:

Each 5 mL (teaspoonful) of pale to light yellow, grape flavored solution contains 26.9 mg prednisolone sodium phosphate (20 mg prednisolone base). NDC 23594-915-08 8 fl oz (237 mL) bottle. Dispense in tight, light resistant glass or PET plastic containers as defined in the USP. Store refrigerated, 2°- 8°C (36°- 46°F). Keep tightly closed and out of the reach of children. Manufactured for: Zylera Pharmaceuticals LLC Research Triangle Park, NC 27713 Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605 R 05/14

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

VERIPRED 20- PREDNISOLONE SODIUM PHOSPHATE SOLUTION
CERECOR, INC.
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VERIPRED 20
(PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION,
20 MG PREDNISOLONE BASE PER 5 ML)
ZYLERA PHARMACEUTICALS
RX ONLY
DESCRIPTION
VERIPRED 20 (20 mg prednisolone per 5 mL) is a dye free, pale to light
yellow solution. Each 5 mL
(teaspoonful) of VERIPRED 20 (20 mg prednisolone per 5 mL) contains
26.9 mg prednisolone
sodium phosphate (20 mg prednisolone base) in a palatable, aqueous
vehicle.
Inactive Ingredients: VERIPRED 20 (20 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.
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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