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

High-Dose Chemotherapy and Stem Cell Transplant in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to First-Line Therapy

Phase 2

Conditions: Brain and Central Nervous System Tumors
Extragonadal Germ Cell Tumor
Testicular Germ Cell Tumor

First Posted Date: 2010-07-30

Last Posted Date: 2013-08-12

Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Target Recruit Count: 47

Registration Number: NCT01172912

Locations: 🇮🇹
Fondazione Istituto Nazionale dei Tumori, Milan, Italy

Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair

Phase 3

Completed

Conditions: Inguinal Hernia
Femoral Hernia

Interventions: Drug: Saline
Drug: Dexamethasone

First Posted Date: 2010-07-27

Last Posted Date: 2024-08-26

Lead Sponsor: Mette Astrup Madsen

Target Recruit Count: 80

Registration Number: NCT01170780

Locations: 🇩🇰
University Hospital Koege, Koege, Denmark

Effects of Steroid Tapering on Functional Capacity and Neurocognition

Not Applicable

Withdrawn

Conditions: Glioblastoma Multiforme

Interventions: Drug: Dexamethasone acetate
Drug: Dexamethasone

First Posted Date: 2010-07-26

Last Posted Date: 2014-05-19

Lead Sponsor: Duke University

Registration Number: NCT01169415

The Effect of Pregabalin and Dexamethasone on Acute and Chronic Pain After Lumbar Spinal Surgery

Not Applicable

Completed

Conditions: Pain

Interventions: Drug: placebo
Drug: Pregabalin
Drug: dexamethasone

First Posted Date: 2010-07-23

Last Posted Date: 2011-08-19

Lead Sponsor: Yonsei University

Target Recruit Count: 108

Registration Number: NCT01168531

Locations: 🇰🇷
Severance Hospital, Seoul, Korea, Republic of

A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer

Phase 2

Completed

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Pemetrexed
Drug: Cisplatin
Drug: Folic Acid
Drug: Vitamin B12
Drug: Dexamethasone

First Posted Date: 2010-07-19

Last Posted Date: 2019-09-25

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 19

Registration Number: NCT01165021

Locations: 🇮🇹
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sondalo, Italy

Study of Decadron, Biaxin, and Pomalidomide in Relapsed/Refractory Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: dexamethasone
Drug: clarithromycin
Drug: Pomalidomide

First Posted Date: 2010-07-09

Last Posted Date: 2019-06-11

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 121

Registration Number: NCT01159574

Locations: 🇺🇸
Weill Cornell Medical College, New York, New York, United States

Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia

Not Applicable

Completed

Conditions: Leukemia

First Posted Date: 2010-07-05

Last Posted Date: 2021-09-13

Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Target Recruit Count: 76

Registration Number: NCT01156883

Locations: 🇮🇹
Azienda Ospedaliera - Nuovo Ospedale "Torrette", Ancona, Italy
🇮🇹
USL 8 - Ospedale S.Donato, Arezzo, Italy
🇮🇹
UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari, Bari, Italy

and more 40 locations

Low-Dose Azacitidine, Lenalidomide, and Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma

Phase 1

Completed

Conditions: Refractory Multiple Myeloma

Interventions: Drug: azacitidine
Drug: lenalidomide
Drug: dexamethasone
Other: DNA methylation analysis
Other: gene expression analysis
Other: bone marrow aspiration
Other: immunohistochemistry staining method
Other: reverse transcriptase-polymerase chain reaction
Other: flow cytometry

First Posted Date: 2010-07-02

Last Posted Date: 2020-11-16

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 45

Registration Number: NCT01155583

Locations: 🇺🇸
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)

Phase 3

Completed

Conditions: PCOS

Interventions: Drug: Dexamethasone
Drug: recombinant human chorionic gonadotropin (r-hCG)

First Posted Date: 2010-06-30

Last Posted Date: 2019-04-30

Lead Sponsor: University of California, San Diego

Target Recruit Count: 24

Registration Number: NCT01154192

Locations: 🇺🇸
UCSD School of Medicine, La Jolla, California, United States

Postoperative New-onset Atrial Fibrillation in Cardiac Surgery: DECS-PNAF Project

Phase 4

Completed

Conditions: Cardiac Surgery
Atrial Fibrillation

Interventions: Drug: Placebo
Drug: Dexamethasone

First Posted Date: 2010-06-14

Last Posted Date: 2014-02-24

Lead Sponsor: UMC Utrecht

Target Recruit Count: 80

Registration Number: NCT01143129

Locations: 🇳🇱
University Medical Center Utrecht, Utrecht, Netherlands

Drug Development Updates

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