MedPath

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
C22H29FO5
CAS Number
50-02-2
Unique Ingredient Identifier
7S5I7G3JQL

Overview

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.

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

Clinical Trials

FDA Approved Products

Tobramycin and Dexamethasone
Manufacturer:Physicians Total Care, Inc.
Route:OPHTHALMIC
Strength:1 mg in 1 mL
Approved: 2011/08/10
NDC:54868-6286
Dexamethasone Sodium Phosphate
Manufacturer:Mylan Institutional LLC
Route:INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE
Strength:4 mg in 1 mL
Approved: 2019/11/04
NDC:67457-418
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
Manufacturer:Advanced Rx Pharmacy of Tennessee, LLC
Route:OPHTHALMIC
Strength:1 mg in 1 g
Approved: 2023/01/11
NDC:80425-0229
Dexamethasone Sodium Phosphate
Manufacturer:Asclemed USA, Inc.
Route:INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE
Strength:4 mg in 1 mL
Approved: 2023/04/04
NDC:76420-555
Dexamethasone Sodium Phosphate
Manufacturer:Medical Purchasing Solutions, LLC
Route:INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE
Strength:4 mg in 1 mL
Approved: 2023/05/16
NDC:71872-7157

Singapore Approved Products

DEXAMETHASONE TABLET 0.5 mg
Manufacturer:BEACONS PHARMACEUTICALS PTE. LTD.
Form:TABLET
Strength:0.5 mg
Online:Yes
Approved: 1990/04/12
Approval:SIN04238P
DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP
Manufacturer:PANPHARMA GMBH
Form:INJECTION
Strength:4 mg/ml
Online:Yes
Approved: 1990/04/23
Approval:SIN04295P
ROXIMETH TABLET 0.5 mg
Manufacturer:DUOPHARMA (M) SDN BHD
Form:TABLET
Strength:0.5 mg
Online:Yes
Approved: 1990/03/01
Approval:SIN03936P
MAXITROL STERILE OPHTHALMIC SUSPENSION
Manufacturer:ALCON-COUVREUR NV
Form:SOLUTION
Strength:1.0 mg/ml
Online:Yes
Approved: 1990/05/02
Approval:SIN04358P
DEXA-GENTAMICIN EYE OINTMENT
Manufacturer:URSAPHARM ARZNEIMITTEL GMBH
Form:OINTMENT
Strength:0.3 mg/g
Online:Yes
Approved: 1998/05/14
Approval:SIN09755P

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

© Copyright 2025. All Rights Reserved by MedPath