PREDNISOLONE SODIUM PHOSPHATE solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Pharmaceutical Associates, Inc.

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Prednisolone Sodium Phosphate Oral Solution (10 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

製品概要:

Prednisolone Sodium Phosphate Oral Solution (10 mg prednisilone base). Each 5 mL (teaspoonful) of grape flavored solution contains 13.4 mg prednisolone sodium phosphate (10 mg prednisolone base) is supplied in the following:. NDC 0121-0773-08:  8 fl oz (237 mL) bottle NDC 0121-0773-16:  16 fl oz (473 mL) bottle Dispense in tight, light-resistant glass or PET plastic containers as defined in the USP. Keep tightly closed and out of the reach of children. Store at 20°-25°C (68°-77°F).  [See USP Controlled Room Temperature]. Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R11/2019

認証ステータス:

Abbreviated New Drug Application

製品の特徴

PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM
PHOSPHATE SOLUTION
PHARMACEUTICAL ASSOCIATES, INC.
----------
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION
(10 MG PREDNISOLONE BASE PER 5 ML)
RX ONLY
DESCRIPTION
Prednisolone Sodium Phosphate Oral Solution (10 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 13.4 mg prednisolone sodium phosphate
(10 mg
prednisolone base) in a palatable, aqueous vehicle.
Prednisolone Sodium Phosphate Oral Solution (10 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
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
21
27
2
8
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 o