PREDNISOLONE SODIUM PHOSPHATE solution

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Burke Therapeutics

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Prednisolone Sodium Phosphate Oral Solution (20 mg prednisolone base 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); congenit

পণ্য সারাংশ:

Each 5 mL (teaspoonful) of grape flavored solution contains 26.9 mg prednisolone sodium phosphate (20 mg prednisolone base). NDC 69101-410-01: 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). Burke Therapeutics, LLC Hot Springs, AR 71913 Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R09/2018

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM PHOSPHATE SOLUTION
BURKE THERAPEUTICS
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PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION
(20 MG PREDNISOLONE BASE PER 5 ML)I410C0918 R09/18
RX ONLY
DESCRIPTION
Prednisolone Sodium Phosphate Oral Solution (20 mg prednisolone base
per 5 mL) is a dye free, pale to
light yellow solution. Each 5 mL (teaspoonful) of Prednisolone Sodium
Phosphate Oral Solution
contains 26.9 mg prednisolone sodium phosphate (20 mg prednisolone
base) in a palatable, aqueous
vehicle.
Inactive Ingredients: Prednisolone Sodium Phosphate Oral Solution (20
mg prednisolone base per 5 mL)
contains the following inactive ingredients: anti-bitter mask, edetate
disodium, glycerin, grape flavor,
high fructose corn syrup, hydroxyethyl cellulose, 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.
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