Application Nr Approved Date Route Status External Links
ANDA040401 2003-02-27 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Prednisolone Oral Solution Is Indicated In The Following Conditions: 1. 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 Nonsuppurative Thyroiditis Hypercalcemia Associated With Cancer 2. 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 Post-Traumatic Osteoarthritis Synovitis Of Osteoarthritis Epicondylitis 3. Collagen Diseases During An Exacerbation Or As Maintenance Therapy In Selected Cases Of: Systemic Lupus Erythematosus Acute Rheumatic Carditis 4. Dermatologic Diseases Pemphigus Bullous Dermatitis Herpetiformis Severe Erythema Multiforme (stevens-Johnson Syndrome) Exfoliative Dermatitis Mycosis Fungoides Severe Psoriasis Severe Seborrheic Dermatitis 5. Allergic States Control Of Severe Or Incapacitating Allergic Conditions Intractable To Adequate Trials Of Conventional Treatment: Seasonal Or Perennial Allergic Rhinitis Bronchial Asthma Contact Dermatitis Atopic Dermatitis Serum Sickness Drug Hypersensitivity Reactions 6. Ophthalmic Diseases Severe Acute And Chronic Allergic And Inflammatory Processes Involving The Eye And Its Adnexa Such As: Allergic Corneal Marginal Ulcers Herpes Zoster Ophthalmicus Anterior Segment Inflammation Diffuse Posterior Uveitis And Choroiditis Sympathetic Ophthalmia Allergic Conjunctivitis Keratitis Chorioretinitis Optic Neuritis Iritis And Iridocyclitis 7. Respiratory Diseases Symptomatic Sarcoidosis Loeffler’s Syndrome Not Manageable By Other Means Berylliosis Fulminating Or Disseminated Pulmonary Tuberculosis When Used Concurrently With Appropriate Chemotherapy Aspiration Pneumonitis 8. Hematologic Disorders Idiopathic Thrombocytopenic Purpura In Adults Secondary Thrombocytopenia In Adults Acquired (autoimmune) Hemolytic Anemia Erythroblastopenia (rbc Anemia) Congenital (erythroid) Hypoplastic Anemia 9. Neoplastic Diseases For Palliative Management Of: Leukemias And Lymphomas In Adults Acute Leukemia Of Childhood 10. Edematous States To Induce A Diuresis Or Remission Of Proteinuria In The Nephrotic Syndrome, Without Uremia, Of The Idiopathic Type Or That Due To Lupus Erythematosus. 11. Gastrointestinal Diseases To Tide The Patient Over A Critical Period Of The Disease In: Ulcerative Colitis Regional Enteritis 12. Miscellaneous Tuberculous Meningitis With Subarachnoid Block Or Impending Block Used Concurrently With Appropriate Antituberculous Chemotherapy. Trichinosis With Neurologic Or Myocardial Involvement. In Addition To The Above Indications Prednisolone Oral Solution Is Indicated For Systemic Dermatomyositis (polymyositis).

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Citric Acid Monohydrate CITRIC ACID MONOHYDRATE Molecular
2. Edetate Disodium EDETATE DISODIUM Molecular
3. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
4. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
5. Water WATER Molecular
6. Saccharin Sodium SACCHARIN SODIUM Molecular
7. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Prednisolone PREDNISOLONE ZINC4097474

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