PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION- 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:

Mission Pharmacal Company

INN (International Name):

Prednisolone Sodium Phosphate

Composition:

PREDNISOLONE 25 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Prednisolone sodium phosphate oral solution (25 mg prednisolone per 5 mL) 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 nephritic 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; i

Product summary:

Each 5 mL (teaspoonful) of Prednisolone Sodium Phosphate Oral Solution contains 33.6 mg prednisolone sodium phosphate (25 mg prednisolone base) in a pale yellow, grape flavored solution.      NDC 0178-0582-08   8 fl oz (237 mL) bottle Dispense in tight, light-resistant glass or PET plastic containers as defined in the USP. Store refrigerated, 2° to 8°C (36° to 46°F). Professional sample:      NDC 0178-0582-01   1 fl oz (30 mL) sample bottle Dispense in tight, light-resistant glass or PET plastic containers as defined in the USP. Store at 20° to 25°C (68° to 77°F). Keep tightly closed and out of the reach of children. Manufactured for: MISSION PHARMACAL COMPANY San Antonio, TX 78230 1355 PSPP-06A CO1 Rev 008120 R08/12

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION- PREDNISOLONE SODIUM
PHOSPHATE SOLUTION
MISSION PHARMACAL COMPANY
----------
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (25 MG PREDNISOLONE BASE
PER 5 ML)
DESCRIPTION
Prednisolone sodium phosphate oral solution (25 mg prednisolone per 5
mL) is a dye free, pale to light
yellow solution. Each 5 mL (teaspoonful) of prednisolone sodium
phosphate oral solution contains 33.6
mg prednisolone sodium phosphate (25 mg prednisolone base) in a
palatable, aqueous vehicle.
Prednisolone sodium phosphate oral solution (25 mg prednisolone per 5
mL) also contains antibitter
mask, corn syrup, edetate disodium, glycerin, grape flavor,
hydroxyethylcellulose, methylparaben,
potassium phosphate dibasic, potassium phosphate monobasic, purified
water, and sodium saccharin.
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, (11ß)-. The
empirical 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
pharmacological effects of prednisolone
which are due to its glucocorticoid pro