PREDNISOLONE SODIUM PHOSPHATE solution

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Edenbridge Pharmaceuticals LLC.

INN (Међународно име):

Prednisolone Sodium Phosphate

Састав:

prednisolone 10 mg in 5 mL

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Prednisolone Sodium Phosphate Oral Solution (10 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (20 mg Prednisolone per 5 mL) and Prednisolone Sodium Phosphate (25 mg Prednisolone per 5 mL) are 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; 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.

Резиме производа:

 Prednisolone Sodium Phosphate Oral Solution (10 mg Prednisolone per 5 mL ) Each 5 mL (teaspoonful) of Prednisolone Sodium Phosphate Oral Solution (10 mg Prednisolone per 5 mL) contains 13.4 mg Prednisolone sodium phosphate (10 mg Prednisolone base)in a pale to light yellow, grape flavored solution. NDC 42799-812-01 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. Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL ) Each 5 mL (teaspoonful) of Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL) contains 20.2 mg Prednisolone sodium phosphate (15 mg Prednisolone base) in a pale to light yellow, grape flavored solution. NDC 42799-815-01 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. Prednisolone Sodium Phosphate Oral Solution (20 mg Prednisolone per 5 mL) Each 5 mL (teaspoonful) of  Prednisolone Sodium Phosphate Oral Solution (20 mg Prednisolone per 5 mL) contains 26.9 mg Prednisolone sodium phosphate (20 mg Prednisolone base) in a pale to light yellow, grape flavored solution. NDC 42799-813-01 8 fl oz (237 mL) bottle Dispense in tight, light-resistant glass or PET plastic containers as defined in the USP. Store at 2°-8°C (36°-46°F) Keep tightly closed and out of the reach of children. Prednisolone Sodium Phosphate Oral Solution (25 mg Prednisolone per 5 mL) Each 5 mL (teaspoonful) of  Prednisolone Sodium Phosphate Oral Solution (25 mg Prednisolone per 5 mL) contains 33.6 mg Prednisolone sodium phosphate (25 mg Prednisolone base) in a pale to light yellow, grape flavored solution. NDC 42799-816-01 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: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054 877-381-3336 Rev. 08/2023

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

PREDNISOLONE SODIUM PHOSPHATE - PREDNISOLONE SODIUM
PHOSPHATE SOLUTION
EDENBRIDGE PHARMACEUTICALS LLC.
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PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION
DESCRIPTION
Prednisolone Sodium Phosphate Oral Solution (10 mg Prednisolone per 5
mL),
Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5
mL),
Prednisolone Sodium Phosphate Oral Solution (20 mg Prednisolone per 5
mL) and
Prednisolone Sodium Phosphate Oral Solution (25 mg Prednisolone per 5
mL) are dye
free, pale to light yellow solutions. Each 5 mL (teaspoonful) of
Prednisolone Sodium
Phosphate Oral Solution contains 13.4 mg prednisolone sodium phosphate
(10 mg
prednisolone base),20.2 mg prednisolone sodium phosphate (15 mg
prednisolone
base), 26.9 mg prednisolone sodium phosphate (20 mg prednisolone base)
or 33.6 mg
prednisolone sodium phosphate (25 mg prednisolone base) in a
palatable, aqueous
vehicle. Inactive Ingredients: Prednisolone Sodium Phosphate Oral
Solution (10 mg
Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution
(15 mg
Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution
(20 mg
Prednisolone per 5 mL) and Prednisolone Sodium Phosphate Oral Solution
(25 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, (11b)-. 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 glucocorticoid