MILLIPRED- 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:

Cerecor, Inc.

INN (International Name):

PREDNISOLONE SODIUM PHOSPHATE

Composition:

PREDNISOLONE 21-PHOSPHATE 10 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Millipred Oral Solution (10 mg Prednisolone per 5 mL) is indicated in the following conditions: 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. Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. 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. 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 supplementation is of particular importance);   congenital   adrenal   hyperpla

Product summary:

Each 5 mL (teaspoonful) of Millipred Oral Solution contains 13.4 mg Prednisolone sodium phosphate (10 mg Prednisolone base) in a grape flavored solution. NDC 23594-510-08 8 fl oz (237 mL) bottle Dispense  in  tight,  light-resistant  glass  or  PET plastic containers as defined in the USP. Store   at   20°-25°C   (68°-77°F).   [See   USP Controlled Room Temperature]. Keep tightly closed and out of the reach of children. Manufactured for: Zylera Pharmaceuticals Research Triangle Park, NC 27713 Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605 Rev 06/2013

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MILLIPRED- PREDNISOLONE SODIUM PHOSPHATE SOLUTION
CERECOR, INC.
----------
MILLIPRED™
(PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION,
10 MG PREDNISOLONE BASE PER 5 ML)
ZYLERA PHARMACEUTICALS
RX ONLY
DESCRIPTION
Millipred Oral Solution (10 mg Prednisolone per 5 mL) is a dye free,
pale to light yellow solution.
Each 5 mL (teaspoonful) of Millipred Oral Solution contains 13.4 mg
prednisolone sodium phosphate
(10 mg prednisolone base) in a palatable, aqueous vehicle. Inactive
Ingredients: Millipred Oral Solution
(10 mg Prednisolone per 5 mL) contains the following inactive
ingredients: anti-bitter 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, (11β)-. The
empirical 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 physiologi- cal 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 whi