PREDNISOLONE SODIUM PHOSPHATE solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

RedPharm Drug, Inc.

INN (nume internaţional):

PREDNISOLONE SODIUM PHOSPHATE

Compoziție:

PREDNISOLONE 15 mg in 5 mL

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Prednisolone Sodium Phosphate Oral Solution (15 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 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; i

Rezumat produs:

Each 5 mL (teaspoonful) of pale to light yellow, grape flavored solution contains 20.2 mg Prednisolone sodium phosphate (15 mg Prednisolone base). NDC 0121-0759-08 8 fl oz (237 mL) bottle Dispense in tight, light-resistant glass or PET plastic containers as defined in the USP. Store at 2° to 25°C (36° to 77°F). May be refrigerated. Keep tightly closed and out of the reach of children. Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R06/09

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM
PHOSPHATE SOLUTION
REDPHARM DRUG, INC.
----------
SPL UNCLASSIFIED SECTION
Rx only
DESCRIPTION
Prednisolone Sodium Phosphate Oral Solution (15 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 20.2 mg prednisolone sodium phosphate
(15 mg
prednisolone base) in a palatable, aqueous vehicle.
Inactive Ingredients: Prednisolone Sodium Phosphate Oral Solution (15
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:
[Chemical Structure]
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 p