Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
PREDNISOLONE SODIUM PHOSPHATE (UNII: IV021NXA9J) (PREDNISOLONE - UNII:9PHQ9Y1OLM)
Cardinal Health
PREDNISOLONE SODIUM PHOSPHATE
PREDNISOLONE 15 mg in 5 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM PHOSPHATE SOLUTION CARDINAL HEALTH ---------- 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 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 C H Na O P; the molecular weight is 484.39. Its chemical structure is: 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 large therapeutic doses of the drug. The Przeczytaj cały dokument