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

A Study to Evaluate the Safety, Tolerability and Efficacy of Intravenous TAK-573 as Part of Combination Therapy in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

Phase 1

Withdrawn

Conditions: Relapsed and/or Refractory Multiple Myeloma

Interventions: Drug: TAK-573
Drug: Bortezomib
Drug: Pomalidomide
Drug: Cyclophosphamide
Drug: Dexamethasone

First Posted Date: 2020-05-19

Last Posted Date: 2020-07-14

Lead Sponsor: Takeda

Registration Number: NCT04392648

Extension of Analgesia by Combined Injection of Dexamethasone and Dexmedetomidine After Arthroscopic Shoulder Surgery

Phase 4

Completed

Conditions: Analgesia

Interventions: Drug: Dexmedetomidine
Drug: Ropivacaine
Drug: Dexamethasone

First Posted Date: 2020-05-19

Last Posted Date: 2022-01-04

Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Target Recruit Count: 122

Registration Number: NCT04394481

Locations: 🇫🇷
Hôpital privé jean Mermoz, Lyon, France

The Combination of High-dose Dexamethasone and Acetylcysteine as the Treatment of Newly-diagnosed ITP

Phase 2

Conditions: Immune Thrombocytopenia

Interventions: Drug: Dexamethasone
Drug: Acetylcysteine

First Posted Date: 2020-04-30

Last Posted Date: 2020-04-30

Lead Sponsor: Peking University People's Hospital

Target Recruit Count: 44

Registration Number: NCT04368598

Locations: 🇨🇳
Peking University Insititute of Hematology, Peking University People's Hospital, Beijing, Beijing, China

Targeted Steroids for ARDS Due to COVID-19 Pneumonia: A Pilot Randomized Clinical Trial

Phase 2

Withdrawn

Conditions: COVID-19
ARDS

Interventions: Drug: Dexamethasone injection
Drug: Placebos

First Posted Date: 2020-04-24

Last Posted Date: 2020-10-28

Lead Sponsor: University of Colorado, Denver

Registration Number: NCT04360876

INCB053914 and Pomalidomide With Dexamethasone for Relapsed and/or Refractory Multiple Myeloma

Phase 1

Withdrawn

Conditions: Relapse Multiple Myeloma
Refractory Multiple Myeloma

Interventions: Drug: Pomalidomide
Drug: Dexamethasone
Drug: INCB053914 65 mg BID
Drug: INCB053914 50 mg bis in die (BID)
Drug: INCB053914 80 mg BID

First Posted Date: 2020-04-21

Last Posted Date: 2020-08-19

Lead Sponsor: Medical College of Wisconsin

Registration Number: NCT04355039

Daratumumab-Based Therapy for the Treatment of Newly Diagnosed Multiple Myeloma With Kidney Failure

Phase 2

Terminated

Conditions: Plasma Cell Myeloma
Renal Failure

Interventions: Drug: Bortezomib
Biological: Daratumumab
Drug: Dexamethasone
Drug: Lenalidomide
Drug: Thalidomide

First Posted Date: 2020-04-20

Last Posted Date: 2024-07-01

Lead Sponsor: Emory University

Target Recruit Count: 17

Registration Number: NCT04352205

Locations: 🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache

Phase 1

Withdrawn

Conditions: Chronic Migraine
Cluster Headache
Trigeminal Neuralgia

Interventions: Drug: Ketorolac
Drug: Dexamethasone

First Posted Date: 2020-04-20

Last Posted Date: 2020-08-04

Lead Sponsor: Weill Medical College of Cornell University

Registration Number: NCT04353505

Locations: 🇺🇸
Weill Cornell Medicine, New York, New York, United States

A Study to Assess Efficacy and Safety of Eltrombopag in Combination With a Short Course of Dexamethasone in Patients With Newly Diagnosed ITP

Phase 2

Completed

Conditions: Immune Thrombocytopenia (ITP)

Interventions: Drug: Eltrombopag
Drug: Dexamethasone

First Posted Date: 2020-04-15

Last Posted Date: 2024-02-01

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 28

Registration Number: NCT04346654

Locations: 🇩🇪
Novartis Investigative Site, Kronach, Germany

Dexamethasone and Oxygen Support Strategies in ICU Patients With Covid-19 Pneumonia

Not Applicable

Conditions: Acute Hypoxemic Respiratory Failure
COVID-19

Interventions: Drug: placebo
Drug: Dexamethasone injection
Procedure: conventional oxygen
Procedure: CPAP
Procedure: mechanical ventilation
Procedure: HFNO