Product manufactured by Direct Rx

Application Nr Approved Date Route Status External Links
ANDA040189 2007-07-20 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Section Methylprednisolone Tablets Are 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 Orexacerbation) In: Rheumatoid Arthritis, Including Juvenile Rheumatoid Arthritis (selected Cases May Require Low-Dose Maintenance Therapy) Ankylosing Spondylitis Acute And Subacute Bursitis Synovitis Of Osteoarthritis Acute Nonspecific Tenosynovitis Post-Traumatic Osteoarthritis Psoriatic Arthritis Epicondylitis Acute Gouty Arthritis 3.collagen Diseases During An Exacerbation Or As Maintenance Therapy In Selected Cases Of: Systemic Lupus Erythematosus Systemic Dermatomyositis (polymyositis) Acute Rheumatic Carditis 4.dermatologic Diseases Bullous Dermatitis Herpetiformis Severe Erythema Multiforme (stevens-Johnson Syndrome) Severe Seborrheic Dermatitis Exfoliative Dermatitis Mycosis Fungoides Pemphigus Severe Psoriasis 5.allergic States Control Of Severe Or Incapacitating Allergic Conditions Intractable To Adequate Trials Of Conventional Treatment: Seasonal Or Perennial Allergic Rhinitis Drug Hypersensitivity Reactions Serum Sickness Contact Dermatitis Bronchial Asthma Atopic Dermatitis 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 Keratitis Optic Neuritis Allergic Conjunctivitis Chorioretinitis Iritis And Iridocyclitis 7.respiratory Diseases Symptomatic Sarcoidosis Berylliosis Loeffler’s Syndrome Not Manageable By Other Means Fulminating Or Disseminated Pulmonary Tuberculosis When Used Concurrently With Appropriate Antituberculous 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.nervous System Acute Exacerbations Of Multiple Sclerosis 13.miscellaneous Tuberculous Meningitis With Subarachnoid Block Or Impending Block When Used Concurrently With Appropriate Antituberculous Chemotherapy. Trichinosis With Neurologic Or Myocardial Involvement.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Methylprednisolone METHYLPREDNISOLONE ZINC3875560