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

The Use of Chemotherapy Plus Radiotherapy Plus Azidothymidine in Patients With AIDS-Related Lymph Node Cancer

Not Applicable

Terminated

Conditions: Lymphoma, Non-Hodgkin
HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2021-10-28

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 45

Registration Number: NCT00000723

Locations: 🇺🇸
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU, New Orleans, Louisiana, United States

Dexamethasone in Cryptococcal Meningitis

Phase 2

Completed

Conditions: Meningitis, Cryptococcal
HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2021-10-28

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 36

Registration Number: NCT00000776

Locations: 🇺🇸
Northwestern Univ Med School, Chicago, Illinois, United States
🇺🇸
Cook County Hosp, Chicago, Illinois, United States
🇺🇸
Univ of Miami School of Medicine, Miami, Florida, United States

and more 11 locations

A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma

Phase 3

Completed

Conditions: HIV Infections
Lymphoma, Non-Hodgkin

First Posted Date: 2001-08-31

Last Posted Date: 2021-11-03

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 250

Registration Number: NCT00000658

Locations: 🇺🇸
UCLA CARE Center CRS, Los Angeles, California, United States
🇺🇸
USC CRS, Los Angeles, California, United States
🇺🇸
Ucsf Aids Crs, San Francisco, California, United States

and more 19 locations

Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma

Phase 2

Completed

Conditions: Lymphoma, Non-Hodgkin
HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2012-11-01

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 33

Registration Number: NCT00000801

Locations: 🇺🇸
Julio Arroyo, West Columbia, South Carolina, United States
🇺🇸
San Francisco Gen Hosp, San Francisco, California, United States
🇺🇸
San Francisco AIDS Clinic / San Francisco Gen Hosp, San Francisco, California, United States

and more 4 locations

Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in AIDS-Associated Large Cell, Immunoblastic, and Small Non-cleaved Lymphoma

Phase 1

Completed

Conditions: Lymphoma, Non-Hodgkin
HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2021-11-02

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 18

Registration Number: NCT00000689

Locations: 🇺🇸
USC CRS, Los Angeles, California, United States

Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)

Phase 3

Terminated

Conditions: Bronchopulmonary Dysplasia
Respiratory Distress Syndrome
Infant, Newborn
Infant, Low Birth Weight
Infant, Small for Gestational Age
Infant, Premature

Interventions: Procedure: Minimal mechanical ventilation management
Procedure: Routine mechanical ventilation management
Drug: Placebo
Drug: Dexamethasone

First Posted Date: 2000-06-02

Last Posted Date: 2015-06-08

Lead Sponsor: NICHD Neonatal Research Network

Target Recruit Count: 220

Registration Number: NCT00005777

Locations: 🇺🇸
Stanford University, Palo Alto, California, United States
🇺🇸
Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States
🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States

and more 10 locations

Once-A-Month Steroid Treatment for Patients With Focal Segmental Glomerulosclerosis

Phase 2

Completed

Conditions: Glomerulonephritis
Nephrotic Syndrome

First Posted Date: 2000-03-20

Last Posted Date: 2008-03-04

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Target Recruit Count: 20

Registration Number: NCT00004990

Locations: 🇺🇸
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Bethesda, Maryland, United States

Phase III Randomized, Double-Blind Study of Dexamethasone Vs Dexamethasone/Methylprednisolone Vs Placebo for Bronchopulmonary Dysplasia

Phase 3

Completed

Conditions: Bronchopulmonary Dysplasia

First Posted Date: 2000-02-25

Last Posted Date: 2005-06-24

Lead Sponsor: National Center for Research Resources (NCRR)

Target Recruit Count: 54

Registration Number: NCT00004785

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery

Phase 3

Completed

Conditions: Respiratory Distress Syndrome

First Posted Date: 2000-02-25

Last Posted Date: 2005-06-24

Lead Sponsor: National Center for Research Resources (NCRR)

Target Recruit Count: 1090

Registration Number: NCT00004778

G-CSF for Granulocyte Donation

Phase 1

Completed

Conditions: Healthy

First Posted Date: 1999-11-04

Last Posted Date: 2008-03-04

Lead Sponsor: National Institutes of Health Clinical Center (CC)

Target Recruit Count: 16

Registration Number: NCT00001842

Locations: 🇺🇸
Warren G. Magnuson Clinical Center (CC), Bethesda, Maryland, United States

Drug Development Updates

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