Dexamethasone

Generic Name: Dexamethasone

Brand Names: Baycadron, Ciprodex, Decadron, Dexamethasone Intensol, Dextenza, Dioptrol, Hexadrol, Hidex 6-day Taper, Maxidex, Maxitrol, Neofordex, Ozurdex, Taperdex 12 Day Taper, Taperdex 6 Day Taper, Taperdex 7-day Taper, Tobradex, Zcort 7 Day Taper

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₉FO_₅

CAS Number: 50-02-2

Unique Ingredient Identifier: 7S5I7G3JQL

Background: Dexamethasone, or MK-125, is a corticosteroid fluorinated at position 9 used to treat endocrine, rheumatic, collagen, dermatologic, allergic, ophthalmic, gastrointestinal, respiratory, hematologic, neoplastic, edematous, and other conditions. Developed in 1957, it is structurally similar to other corticosteroids like hydrocortisone and prednisolone.

Dexamethasone was granted FDA approval on 30 October 1958. In a press release for the Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial on 16 June 2020, dexamethasone was recommended for use in COVID-19 patients with severe respiratory symptoms. Dexamethasone reduced deaths by approximately one third in patients requiring ventilation and by one fifth in those requiring oxygen.

Indication: Dexamethasone and ciprofloxacin otic suspension is indicated for bacterial infections with inflammation in acute otitis media and acute otitis externa. Intramuscular and intravenous injections are indicated for a number of endocrine, rheumatic, collagen, dermatologic, allergic, ophthalmic, gastrointestinal, respiratory, hematologic, neoplastic, edematous, and other conditions. Oral tablets are indicated for the treatment of multiple myeloma. An intravitreal implant is indicated for some forms of macular edema and non-infectious posterior uveitis affecting the posterior of the eye. Various ophthalmic formulations are indicated for inflammatory conditions of the eye.

Associated Conditions: Acute Gouty Arthritis, Acute Leukemia, Acute Otitis Externa, Acute Otitis Media (AOM), Adrenocortical Hyperfunction, Adrenocortical Insufficiency, Allergic Conjunctivitis (AC), Alopecia Areata (AA), Ankylosing Spondylitis (AS), Aspiration Pneumonitis, Asthma, Atopic Dermatitis, Berylliosis, Bullous dermatitis herpetiformis, Bursitis, Chorioretinitis, Choroiditis, Congenital Adrenal Hyperplasia (CAH), Congenital Hypoplastic Anemia, Conjunctivitis, Contact Dermatitis, Cushing's Syndrome, Dermatitis, Diabetic Macular Edema (DME), Discoid Lupus Erythematosus (DLE), Drug hypersensitivity reaction, Edema of the cerebrum, Epicondylitis, Episcleritis, Erythroblastopenia, Eye Infections, Eye allergy, Glaucoma, Hypercalcemia, Immune Thrombocytopenia (ITP), Infection, Inflammation, Inflammation of the External Auditory Canal, Intraocular Inflammation, Iridocyclitis, Iritis, Keloids Scars, Keratitis, Lichen Planus (LP), Lichen simplex chronicus, Loeffler's syndrome, Lymphoma, Macular Edema, Meningitis caused by Mycobacterium Tuberculosis, Middle ear inflammation, Mucosal Inflammation of the eye, Multiple Myeloma (MM), Muscle Inflammation caused by Cataract Surgery of the eye, Mycosis Fungoides (MF), Necrobiosis lipoidica diabeticorum, Non-infectious Posterior Uveitis, Ocular Infections, Irritations and Inflammations, Ocular Inflammation, Ocular Inflammation and Pain, Ocular Irritation, Ocular Itching, Ophthalmia, Sympathetic, Optic Neuritis, Otitis Externa, Pemphigus, Perennial Allergic Rhinitis (PAR), Phlyctenular keratoconjunctivitis, Postoperative Infections of the eyes caused by susceptible bacteria, Posttraumatic Osteoarthritis, Regional Enteritis, Rheumatoid Arthritis, Rheumatoid Arthritis, Juvenile, Rosacea, Sarcoidosis, Scleritis, Seasonal Allergic Rhinitis, Secondary thrombocytopenia, Serum Sickness, Severe Seborrheic Dermatitis, Stevens-Johnson Syndrome, Synovitis, Systemic Lupus Erythematosus, Tenosynovitis, Trichinosis, Tuberculosis (TB), Ulcerative Colitis, Uveitis, Vernal Keratoconjunctivitis, Acquired immune hemolytic anemia, Acute rheumatic carditis, Anterior eye segment inflammation, Corticosteroid-responsive dermatoses, Ear infection-not otherwise specified caused by susceptible bacteria, Exfoliative erythroderma, Granuloma annulare lesions, Non-suppurative Thyroiditis, Ocular bacterial infections, Severe Psoriasis, Steroid-responsive inflammation of the eye, Swelling of the eyes, Varicella-zoster virus acute retinal necrosis, Watery itchy eyes

Associated Therapies: -

Clinical Trials

S9805, High-Dose Melphalan Plus Peripheral Stem Cell Transplantation Followed by Interferon Alfa in Treating Patients With Waldenstrom's Macroglobulinemia

Phase 2

Completed

Conditions: Lymphoma

Interventions: Biological: filgrastim
Biological: recombinant interferon alfa
Drug: dexamethasone
Drug: melphalan
Procedure: peripheral blood stem cell transplantation

First Posted Date: 2004-08-03

Last Posted Date: 2015-03-06

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 9

Registration Number: NCT00003416

Locations: 🇺🇸
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
🇺🇸
Arizona Cancer Center, Tucson, Arizona, United States
🇺🇸
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, United States

and more 81 locations

Drugs to Reduce the Side Effects of Chemotherapy

Phase 3

Completed

Conditions: Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific

Interventions: Drug: dexamethasone
Drug: granisetron hydrochloride
Drug: metoclopramide hydrochloride

First Posted Date: 2004-08-02

Last Posted Date: 2012-07-11

Lead Sponsor: Swiss Group for Clinical Cancer Research

Target Recruit Count: 267

Registration Number: NCT00003213

Locations: 🇨🇭
Istituto Oncologico della Svizzera Italiana, Lugano, Switzerland
🇨🇭
Burgerspital, Solothurn, Solothurn, Switzerland
🇮🇹
Istituto Europeo Di Oncologia, Milano, Italy

and more 7 locations

SWOG-9400 Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Previously Untreated Acute Lymphocytic Leukemia

Phase 2

Completed

Conditions: Leukemia
Neutropenia
Thrombocytopenia

First Posted Date: 2004-07-29

Last Posted Date: 2015-03-06

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 50

Registration Number: NCT00002665

Locations: 🇺🇸
CCOP - Dayton, Kettering, Ohio, United States
🇺🇸
Boston Medical Center, Boston, Massachusetts, United States
🇺🇸
Cleveland Clinic Cancer Center, Cleveland, Ohio, United States

and more 80 locations

Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain

Not Applicable

Conditions: Brain and Central Nervous System Tumors
Cognitive/Functional Effects
Radiation Toxicity

First Posted Date: 2004-07-16

Last Posted Date: 2013-12-18

Lead Sponsor: Barrett Cancer Center

Target Recruit Count: 30

Registration Number: NCT00087815

Locations: 🇺🇸
University of Cincinnati Medical Center, Cincinnati, Ohio, United States

Combination Chemotherapy With or Without Interferon Alfa in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma

Phase 3

Conditions: Lymphoma

First Posted Date: 2004-07-16

Last Posted Date: 2013-09-17

Lead Sponsor: Scotland and Newcastle Lymphoma Group

Target Recruit Count: 200

Registration Number: NCT00003639

Locations: 🇬🇧
Royal Victoria Infirmary, Newcastle-upon-Tyne, England, United Kingdom

Combination Chemotherapy in Treating Pediatric Patients With Stage III or IV Non-Hodgkin's Lymphoma

Phase 2

Completed

Conditions: Lymphoma

First Posted Date: 2004-07-01

Last Posted Date: 2013-06-25

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Registration Number: NCT00002691

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Radiation Therapy and Chemotherapy in Treating Children With CNS Relapse From Acute Lymphoblastic Leukemia

Phase 2

Completed

Conditions: Leukemia

Interventions: Biological: filgrastim
Drug: asparaginase
Drug: cyclophosphamide
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: etoposide
Drug: leucovorin calcium
Drug: liposomal cytarabine
Drug: mercaptopurine
Drug: mesna
Drug: methotrexate
Drug: therapeutic hydrocortisone
Drug: thiotepa
Drug: vincristine sulfate
Radiation: low-LET electron therapy
Radiation: low-LET photon therapy

First Posted Date: 2004-07-01

Last Posted Date: 2013-02-01

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 156

Registration Number: NCT00002704

Locations: 🇺🇸
West Virginia University Hospitals, Morgantown, West Virginia, United States
🇺🇸
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
🇺🇸
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States

and more 67 locations

Combination Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia

Phase 3

Completed

Conditions: Leukemia

Interventions: Drug: cytarabine
Drug: dexamethasone
Drug: etoposide
Drug: idarubicin
Drug: ifosfamide
Drug: leucovorin calcium
Drug: mesna
Drug: pegaspargase
Drug: therapeutic hydrocortisone
Drug: thioguanine
Drug: vincristine sulfate
Radiation: low-LET electron therapy
Radiation: low-LET cobalt-60 gamma ray therapy
Radiation: low-LET photon therapy
Drug: Methotrexate

First Posted Date: 2004-06-23

Last Posted Date: 2013-08-22

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 120

Registration Number: NCT00002816

Locations: 🇺🇸
Children's National Medical Center, Washington, District of Columbia, United States
🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
🇺🇸
Kaplan Cancer Center, New York, New York, United States

and more 30 locations

Combination Chemotherapy, Bone Marrow Transplantation, and Radiation Therapy in Treating Infants With Acute Lymphoblastic Leukemia

Phase 2

Completed

Conditions: Leukemia

First Posted Date: 2004-06-16

Last Posted Date: 2014-07-24

Lead Sponsor: Children's Oncology Group

Registration Number: NCT00002785

Locations: 🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
🇺🇸
Ireland Cancer Center, Cleveland, Ohio, United States

and more 30 locations

Calcitriol and Gefitinib With or Without Dexamethasone in Treating Patients With Advanced Solid Tumors

Phase 1

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

First Posted Date: 2004-06-11

Last Posted Date: 2014-01-13

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 53

Registration Number: NCT00084708

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

Drug Development Updates

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