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 NY LLC

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:

Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL). Each 5 mL (teaspoonful) of pale to yellow grape flavored solution contains 20.2 mg prednisolone sodium phosphate (15 mg prednisolone, USP base). NDC 69238-2122-9    8 fl oz (237 mL) amber PET bottle with child-resistant closure   Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep tightly closed and out of the reach of children. Dispense in tight, light-resistant glass or PET plastic containers as defined in USP. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 05-2023-02

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM
PHOSPHATE SOLUTION
AMNEAL PHARMACEUTICALS NY LLC
----------
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION
DESCRIPTION
Prednisolone sodium phosphate oral solution is a dye free, pale to
light yellow grape
flavored solution. Each 5 mL (teaspoonful) of prednisolone sodium
phosphate oral
solution contains 20.2 mg prednisolone sodium phosphate, USP (15 mg
prednisolone,
USP base) in a palatable, aqueous vehicle. Prednisolone sodium
phosphate oral solution
(15 mg prednisolone per 5 mL) contains the following inactive
ingredients: edetate
disodium, fructose, glycerin, hydroxyethylcellulose, methylparaben,
potassium
phosphate dibasic, potassium phosphate monobasic, purified water,
sodium saccharin,
bitter masker flavor, grape type flavor.
Prednisolone sodium phosphate, USP occurs as white to almost white
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, USP
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:
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.
21
27
2
8
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
glucocorti