Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
PREDNISOLONE SODIUM PHOSPHATE (UNII: IV021NXA9J) (PREDNISOLONE - UNII:9PHQ9Y1OLM)
Medstone Pharma LLC
ORAL
PRESCRIPTION DRUG
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
Each 5 mL (teaspoonful) of grape flavored solution contains 26.9 mg prednisolone sodium phosphate (20 mg prednisolone base). NDC 71626-902-05: unit dose cups of 5 mL Dispense in tight, light-resistant glass or PET plastic containers as defined in the USP. Store refrigerated, 2°-8°C (36°-46°F). Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R09/2018
Abbreviated New Drug Application
PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM PHOSPHATE SOLUTION MEDSTONE PHARMA LLC ---------- PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (20 MG PREDNISOLONE BASE PER 5 ML) 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, high fructose 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 21 27 2 8 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 large Đọc toàn bộ tài liệu