Application Nr Approved Date Route Status External Links
ANDA040803 None Intra-Articular None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage A. By Intravenous Or Intramuscular Injection When Oral Therapy Is Not Feasible: 1. Endocrine Disorders: Primary Or Secondary Adrenocortical Insufficiency (Hydrocortisone Or Cortisone Is The Drug Of Choice; Synthetic Analogs May Be Used In Conjunction With Mineralocorticoids Where Applicable; In Infancy, Mineralocorticoid Supplementation Is Of Particular Importance). 2. Rheumatic Disorders: As Adjunctive Therapy For Short-Term Administration (To Tide The Patient Over An Acute Episode Or Exacerbation) In: Post-Traumatic Osteoarthritis. Synovitis Of Osteoarthritis. Rheumatoid Arthritis, Including Juvenile Rheumatoid Arthritis (Selected Cases May Require Low-Dose Maintenance Therapy). Acute And Subacute Bursitis. Epicondylitis. Acute Nonspecific Tenosynovitis. Acute Gouty Arthritis. Psoriatic Arthritis. Ankylosing Spondylitis. 3. Collagen Diseases: During An Exacerbation Or As Maintenance Therapy In Selected Cases Of : Systemic Lupus Erythematosus. Acute Rheumatic Carditis. 4. Dermatologic Diseases: Pemphigus. Severe Erythema Multiforme. (Stevens-Johnson Syndrome) Exfoliative Dermatitis. Bullous Dermatitis Herpetiformis. Severe Seborrheic Dermatitis. Severe Psoriasis. Mycosis Fungoides. 5. Allergic States : Control Of Severe Or Incapacitating Allergic Conditions Intractable To Adequate Trials Of Conventional Treatement In: Bronchial Asthma. Contact Dermatitis. Atopic Dermatitis. Serum Sickness. Seasonal Or Perennial Allergic Rhinitis. Drug Hypersensitivity Reactions. Urticarial Transfusion Reactions. Acute Noninfectious Laryngeal Edema (Epinephrine Is The Drug Of First Choice). 6. Ophthalmic Diseases: Severe Acute And Chronic Allergic And Inflammatory Processes Involving The Eye, Such As: Herpes Zoster Ophthalmicus. Iritis, Iridocyclitis. Chorioretinitis. Diffuse Posterior Uveitis And Choroiditis. Optic Neuritis. Sympathetic Ophthalmia. Anterior Segment Inflammation. Allergic Conjunctivitis. Keratitis. Allergic Corneal Marginal Ulcers. 7. Gastrointestinal Diseases: To Tide The Patient Over A Critical Period Of The Disease In: Ulcerative Colitis (Systemic Therapy). Regional Enteritis (Systemic Therapy). 8. Respiratory Diseases: Systematic Sarcoidosis. Berylliosis. Fulmination Or Disseminated Pulmonary Tuberculosis When Used Concurrently With Appropriate Antituberculous Chemotherapy. Loeffler's Syndrome Not Manageable By Other Means. Aspiration Pneumonitis. 9. Hematologic Disorders: Acquired (Autoimmune) Hemolytic Anemia. Idiopathic Thrombocytopenic Purpura In Adults (Iv Only; Im Administration Is Contraindicated). Secondary Thrombocytopenia In Adults. Erythroblastopenia (Rbc Anemia). Congenital (Erythroid) Hypoplastic Anemia. 10. Neoplastic Diseases: Palliative Management Of: Leukemias And Lymphomas In Adults. Acute Leukemia Of Childhood. 11. Neoplastic Diseases: To Induce Diuresis Or Remission Of Proteinuria In The Nephrotic Syndrome, Without Uremia, Of The Idiopathic Type Or That Due To Lupus Erythematosus. 12. Miscellaneous: Tuberculosis Meningitis With Subarachnoid Block Or Impending Block When Used Concurrently With Appropriate Antituberculous Chemotherapy. Trichinosis With Neurologic Or Myocardial Involvement. 13. Diagnostic Testing Of Adrenocortical Hyperfunction. 14. Cerebral Edema Associated With Primary Or Metastatic Brain Tumor, Craniotomy, Or Head Injury. Use In Cerebral Edema Is Not A Substitute For Careful Neurosurgical Evaluation And Definitive Management Such As Neruosurgery Or Other Specific Therapy. B. By Intra-Articular Or Soft Tissue Injection: As Adjunctive Therapy For Short-Term Administration (To Tide The Patient Over An Acute Episode Or Exacerbation) In: Synovitis Of Osteoarthritis. Rheumatoid Arthritis. Acute And Subacute Bursitis. Acute Gouty Arthritis. Epicondylitis. Acute Nonspecific Tenosynovitis. Post-Traumatic Osteoarthritis. C. By Intralesional Injection: Keloids. Localized Hypertrophic, Infiltrated, Inflammatory Lesions Of: Lichen Planus, Psoriatic Plaques, Granuloma Annulare, And Lichen Simples Chronicus (Neurodermatitis). Discoid Lupus Erythematosus. Necrobiosis Lipoidica Diabeticorum. Alopecia Areata. May Also Be Useful In Cystic Tumors Of An Aponeurosis Or Tendion (Ganglia).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE ZINC4654654

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