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:

A-S Medication Solutions

DCI (Denominação Comum Internacional):

PREDNISOLONE SODIUM PHOSPHATE

Composição:

PREDNISOLONE 15 mg in 5 mL

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Prednisolone sodium phosphate oral solution is indicated in the following conditions: - 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. - Dermatologic Diseases: Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. - 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. - 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 mineralocort

Resumo do produto:

Product: 50090-0955 NDC: 50090-0955-0 237 mL in a BOTTLE, PLASTIC

Status de autorização:

Abbreviated New Drug Application

Características técnicas

PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM PHOSPHATE SOLUTION
A-S MEDICATION SOLUTIONS
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PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION, 15 MG/5 ML
RX ONLY
DESCRIPTION
Prednisolone Sodium Phosphate Oral Solution is a dye free, pale 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: alcohol 1.8%,
dibasic sodium phosphate, glycerin,
liquid sugar, monobasic sodium phosphate, natural and artificial grape
flavor, purified water, sodium
benzoate and sorbitol solution. It may contain 10% dibasic sodium
phosphate solution and/or 10%
monobasic sodium phosphate solution to adjust pH between 6.0 and 8.0.
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
11β,17,21-Trihydroxypregna-1,4-diene-3,20-dione 21-(disodium
phosphate). The molecular formula is
C21H27Na2O8P; 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
admin