PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION- prednisolone sodium phosphate solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

BioComp Pharma, Inc.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. 5. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis. 6. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults; selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; Diamond-Blackfan anemia. 7. Neoplastic Diseases For the treatment of acute leukemia and aggressive lymphomas in adults and children. 8. Nervous System Acute exacerbations of multiple sclerosis. 9. Ophthalmic Diseases Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia. 10. Respiratory Diseases 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. 11. Rheumatic Disorders 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. 12. Miscellaneous 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.

Ringkasan produk:

ach 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: BioComp Pharma, Inc. San Antonio, TX 78230 1355 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 44523-182-08 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). Keep tightly closed and out of the reach of children.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION- PREDNISOLONE SODIUM
PHOSPHATE SOLUTION
BIOCOMP PHARMA, INC.
----------
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 21H
27Na 2O 8P; 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 p