PREDNISOLONE SODIUM PHOSPHATE solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

ATLANTIC BIOLOGICALS CORP.

INN (International namn):

PREDNISOLONE SODIUM PHOSPHATE

Sammansättning:

PREDNISOLONE 15 mg in 5 mL

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Prednisolone Sodium Phosphate Oral Solution (15 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 hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis. Idiopathic thrombocytopenic purpura in adults; selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; Diamond-Blackfan anemia. For the treatment of acute leukemia and aggressive lymphomas in adults and children. Acute exacerbations of multiple sclerosis. Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia. Symptomatic sarcoidosis; idiopathic eosinophilic pneumonias; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; asthma (as distinct from allergic asthma listed above under "Allergic States"), hypersensitivity pneumonitis, idiopathic pulmonary fibrosis, acute exacerbations of chronic obstructive pulmonary disease (COPD), and Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti-PCP antibiotics. Studies support the efficacy of systemic corticosteroids for the treatment of these conditions: allergic bronchopulmonary aspergillosis, idiopathic bronchiolitis obliterans with organizing pneumonia. As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; epicondylitis. For the treatment of systemic lupus erythematosus, dermatomyositis (polymyositis), polymyalgia rheumatica, Sjogren's syndrome, relapsing polychondritis, and certain cases of vasculitis. Tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, and tuberculosis with pleural or pericardial effusion (appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications); trichinosis with neurologic or myocardial involvement; acute or chronic solid organ rejection (with or without other agents). Systemic fungal infections. Hypersensitivity to the drug or any of its components.

Produktsammanfattning:

Product: 17856-0759 NDC: 17856-0759-5 5 mL in a CUP NDC: 17856-0759-1 5 mL in a SYRINGE, PLASTIC NDC: 17856-0759-2 10 mL in a CUP, UNIT-DOSE

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM
PHOSPHATE SOLUTION
ATLANTIC BIOLOGICALS CORP.
----------
PREDNISOLONE SODIUM PHOSPHATE
ORAL SOLUTION
(15 MG PREDNISOLONE BASE PER 5 ML)
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 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 dos