PREDNISOLONE SODIUM PHOSPHATE solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Morton Grove Pharmaceuticals, Inc.

INN (Jina la Kimataifa):

PREDNISOLONE SODIUM PHOSPHATE

Tungo:

PREDNISOLONE 15 mg in 5 mL

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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

Bidhaa muhtasari:

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

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

PREDNISOLONE SODIUM PHOSPHATE - PREDNISOLONE SODIUM
PHOSPHATE SOLUTION
MORTON GROVE PHARMACEUTICALS, INC.
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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