PREDNISOLONE SODIUM PHOSPHATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

PREDNISOLONE SODIUM PHOSPHATE

Composition:

PREDNISOLONE 15 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Prednisolone Sodium Phosphate Oral Solution is indicated in the following conditions: 1. 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. 2. Dermatologic Diseases Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3. 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. 4. 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 mineralocorticoid su

Product summary:

Each 5 mL (teaspoonful) of grape flavored, pale yellow solution contains 20.2 mg prednisolone sodium phosphate (15 mg prednisolone base). Available as: 3 fl oz (89 mL) NDC 65162-667-76 8 fl oz (237 mL) NDC 65162-667-88 16 fl oz (473 mL) NDC 65162-667-90 Dispense in tight, light-resistant container as defined in USP. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. May be refrigerated. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN Rx only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM PHOSPHATE SOLUTION
AMNEAL PHARMACEUTICALS LLC
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PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION
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, grape flavor, monobasic sodium phosphate, sodium benzoate,
sorbitol solution, sucrose,
water.
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 large therapeutic doses of the drug. The
pharmacological effects of prednisolone
which are due to its glucocorticoid properties include: promotion of
gluconeogenes