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

Randomized Controlled Trials of the Effects of Decadron on Swallowing, Airway, and Arthrodesis

Phase 1

Conditions: Swallowing

Interventions: Drug: Saline
Drug: Decadron

First Posted Date: 2010-02-10

Last Posted Date: 2010-02-10

Lead Sponsor: Albany Medical College

Target Recruit Count: 200

Registration Number: NCT01065961

Locations: 🇺🇸
Albany Medical Center, Albany, New York, United States

Dexamethasone in the Treatment of Bronchiolitis in Patients With Either Eczema and or Family History of Asthma

Phase 1

Completed

Conditions: Bronchiolitis

Interventions: Drug: Dexamethasone
Drug: Placebo

First Posted Date: 2010-02-09

Last Posted Date: 2016-08-10

Lead Sponsor: Hamad Medical Corporation

Target Recruit Count: 200

Registration Number: NCT01065272

Locations: 🇶🇦
Hamad Medical Corporation, Pediatric Emergency Center,Alsaad., Doha, Qatar

The Adrenal Contribution to Androgen Production in Girls During Puberty

Phase 3

Completed

Conditions: Development

Interventions: Drug: Adrenocorticotropin
Drug: Dexamethasone

First Posted Date: 2010-02-04

Last Posted Date: 2019-08-26

Lead Sponsor: University of California, San Diego

Target Recruit Count: 50

Registration Number: NCT01062568

Locations: 🇺🇸
University of california, san diego, La Jolla, California, United States

Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma
Stage III Multiple Myeloma
Stage II Multiple Myeloma
Stage I Multiple Myeloma

Interventions: Drug: carfilzomib
Drug: cyclophosphamide
Drug: thalidomide
Drug: dexamethasone

First Posted Date: 2010-01-27

Last Posted Date: 2017-12-12

Lead Sponsor: Mayo Clinic

Target Recruit Count: 64

Registration Number: NCT01057225

Locations: 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

Study to Evaluate the Combination of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Bendamustine
Drug: Bortezomib
Drug: Dexamethasone

First Posted Date: 2010-01-26

Last Posted Date: 2017-05-03

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 59

Registration Number: NCT01056276

Locations: 🇺🇸
Hematology Oncology Clinic, LLP, Baton Rouge, Louisiana, United States
🇺🇸
Los Robles Hospital and Medical Center, Thousand Oaks, California, United States
🇺🇸
Florida Cancer Specialists, Ft. Myers, Florida, United States

and more 10 locations

S0833, Bortezomib, Thalidomide, Lenalidomide, Combination Chemotherapy, and Autologous Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma

Phase 2

Withdrawn

Conditions: Multiple Myeloma
Plasma Cell Myeloma

Interventions: Drug: bortezomib
Drug: cisplatin
Drug: cyclophosphamide
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: lenalidomide
Drug: melphalan
Drug: thalidomide
Genetic: gene expression analysis
Genetic: microarray analysis
Other: laboratory biomarker analysis
Procedure: autologous-autologous tandem hematopoietic stem cell transplantation

First Posted Date: 2010-01-25

Last Posted Date: 2015-03-06

Lead Sponsor: SWOG Cancer Research Network

Registration Number: NCT01055301

Locations: 🇺🇸
Harborview Medical Center, Seattle, Washington, United States
🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
🇺🇸
Group Health Central Hospital, Seattle, Washington, United States

and more 18 locations

Study of Single Agent Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Lenalidomide
Drug: Prednisone
Drug: Dexamethasone

First Posted Date: 2010-01-22

Last Posted Date: 2021-10-13

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 27

Registration Number: NCT01054144

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Bendamustine Hydrochloride, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma

Phase 1

Completed

Conditions: Refractory Multiple Myeloma

Interventions: Drug: bendamustine hydrochloride
Drug: lenalidomide
Drug: dexamethasone

First Posted Date: 2010-01-15

Last Posted Date: 2020-02-11

Lead Sponsor: Mayo Clinic

Target Recruit Count: 70

Registration Number: NCT01049945

Locations: 🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸
University of Chicago, Chicago, Illinois, United States

and more 2 locations

The Effect of Dexamethasone on Cortisol Levels in Patients Undergoing Thyroid Surgery

Phase 4

Withdrawn

Conditions: Adrenal Insufficiency

Interventions: Other: Placebo
Drug: Dexamethasone

First Posted Date: 2010-01-11

Last Posted Date: 2016-04-19

Lead Sponsor: St. Paul's Hospital, Canada

Registration Number: NCT01045876

Locations: 🇨🇦
St Paul's Hospital, Vancouver, British Columbia, Canada

Bendamustine in Combination With Lenalidomide and Dexamethasone in Refractory or Relapsed Multiple Myeloma

Phase 1

Completed

Conditions: Myeloma

Interventions: Drug: Bendamustine
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Aspirin
Drug: Prophylaxis
Drug: Antibiotic
Other: Biweekly Follow Up
Other: Cyclical Follow Up
Other: Restaging
Other: Post-Treatment Follow Up

First Posted Date: 2010-01-05

Last Posted Date: 2017-07-31

Lead Sponsor: Robert Redner, MD

Target Recruit Count: 29

Registration Number: NCT01042704

Locations: 🇺🇸
UPMC Cancer Centers - Arnold Palmer at Mountain View, Greensburg, Pennsylvania, United States
🇺🇸
UPMC Cancer Centers - Arnold Palmer at Oakbrook, Greensburg, Pennsylvania, United States
🇺🇸
Hematology/Oncology - Private Practice, McKeesport, Pennsylvania, United States

and more 19 locations

Drug Development Updates

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