Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
PREDNISOLONE SODIUM PHOSPHATE (UNII: IV021NXA9J) (PREDNISOLONE - UNII:9PHQ9Y1OLM)
Morton Grove Pharmaceuticals, Inc.
PREDNISOLONE SODIUM PHOSPHATE
PREDNISOLONE 15 mg in 5 mL
ORAL
PRESCRIPTION DRUG
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
Prednisolone Sodium Phosphate Oral Solution is a clear, grape flavored solution, containing 20.2 mg prednisolone sodium phosphate (15 mg prednisolone base) per 5 mL (teaspoonful). Available as: 8 fl oz (237 mL) PET bottles (NDC 60432-212-08). Dispense in tight, light-resistant glass or PET plastic containers as defined in USP. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep tightly closed and out of the reach of children. Product No.: 8212 Manufactured For: Wockhardt USA, LLC., Parsippany, NJ 07054 Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053 A50-8212-08 REV. 07-18
Abbreviated New Drug Application
PREDNISOLONE SODIUM PHOSPHATE - PREDNISOLONE SODIUM PHOSPHATE SOLUTION MORTON GROVE PHARMACEUTICALS, INC. ---------- 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 Прочитать полный документ