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.
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/11 | Not Applicable | Not yet recruiting | Poznan University of Medical Sciences | ||
2025/07/09 | Not Applicable | Recruiting | |||
2025/07/07 | Not Applicable | Active, not recruiting | |||
2025/07/04 | Not Applicable | Not yet recruiting | The Children's Hospital of Zhejiang University School of Medicine | ||
2025/06/25 | Not Applicable | ENROLLING_BY_INVITATION | |||
2025/06/24 | Phase 1 | Not yet recruiting | |||
2025/06/15 | Phase 4 | Recruiting | Poznan University of Medical Sciences | ||
2025/06/13 | Phase 2 | Not yet recruiting | Hellenic Society of Hematology | ||
2025/06/12 | Phase 2 | Not yet recruiting | |||
2025/06/11 | Not Applicable | Not yet recruiting | The First Affiliated Hospital of Soochow University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aidarex Pharmaceuticals LLC | 53217-310 | ORAL | 0.5 mg in 5 mL | 5/21/2018 | |
| Quality Care Products, LLC | 55700-854 | ORAL | 1.5 mg in 1 1 | 3/31/2020 | |
| Imprimis NJOF, LLC | 71384-513 | OPHTHALMIC | 1 mg in 1 mL | 2/10/2020 | |
| RedPharm Drug | 67296-0326 | ORAL | 4 mg in 1 1 | 1/19/2022 | |
| Aidarex Pharmaceuticals LLC | 33261-551 | OPHTHALMIC | 1 mg in 1 mL | 8/14/2018 | |
| Eugia US LLC | 55150-304 | INTRAVENOUS, INTRAMUSCULAR | 10 mg in 1 mL | 2/17/2024 | |
| Amneal Pharmaceuticals NY LLC | 60219-2044 | ORAL | 6 mg in 1 1 | 12/28/2023 | |
| Mylan Institutional LLC | 67457-421 | INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE | 4 mg in 1 mL | 3/5/2024 | |
| Medical Purchasing Solutions, LLC | 71872-7164 | INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE | 4 mg in 1 mL | 5/15/2023 | |
| DIRECT RX | 61919-113 | OPHTHALMIC | 1 mg in 1 g | 1/21/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/26/2010 | ||
N/A | N/A | N/A |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DEXAMETHASONE TABLET 0.5 mg | SIN04238P | TABLET | 0.5 mg | 4/12/1990 | |
| DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP | SIN04295P | INJECTION | 4 mg/ml | 4/23/1990 | |
| ROXIMETH TABLET 0.5 mg | SIN03936P | TABLET | 0.5 mg | 3/1/1990 | |
| MAXITROL STERILE OPHTHALMIC SUSPENSION | SIN04358P | SOLUTION | 1.0 mg/ml | 5/2/1990 | |
| DEXA-GENTAMICIN EYE OINTMENT | SIN09755P | OINTMENT | 0.3 mg/g | 5/14/1998 | |
| DBL DEXAMETHASONE SODIUM PHOSPHATE INJECTION 4 mg/ml | SIN04162P | INJECTION | 4mg/mL | 4/20/1990 | |
| DEXALTIN ORAL PASTE 1 mg/g | SIN05232P | PASTE | 1 mg/g | 11/30/1990 | |
| DEXAMETHASONE TABLET 4 mg | SIN07155P | TABLET | 4 mg | 10/12/1992 | |
| DEXASONE TABLET 0.5 mg | ATLANTIC LABORATORIES CORPN LTD | SIN04860P | TABLET | 0.5 mg | 6/29/1990 |
| CILODEX OTIC SUSPENSION | SIN13199P | SOLUTION | 0.1% | 4/18/2006 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Dexamethasone Acetate Injection | 国药准字H51020514 | 化学药品 | 注射剂(注射液) | 11/9/2020 | |
| Dexamethasone Acetate Injection | 国药准字H51020723 | 化学药品 | 注射剂(注射液) | 11/9/2020 | |
| Dexamethasone Acetate Injection | 国药准字H51020513 | 化学药品 | 注射剂(注射液) | 11/9/2020 | |
| Dexamethasone Tablets | 国药准字H44024276 | 化学药品 | 片剂 | 3/11/2020 | |
| Dexamethasone Tablets | 国药准字H44024469 | 化学药品 | 片剂 | 9/17/2020 | |
| Dexamethasone Tablets | 国药准字H44024501 | 化学药品 | 片剂 | 4/26/2024 | |
| Dexamethasone Tablets | 国药准字H35021170 | 化学药品 | 片剂 | 7/13/2020 | |
| Dexamethasone Tablets | 国药准字H44024618 | 化学药品 | 片剂 | 5/9/2020 | |
| Dexamethasone Tablets | 国药准字H14023304 | 化学药品 | 片剂 | 4/10/2020 | |
| Dexamethasone Acetate Cream | 国药准字H37021978 | 化学药品 | 乳膏剂 | 2/12/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| DEXA-GENTAMICIN EYE OINTMENT | N/A | N/A | N/A | 4/12/2011 | |
| MEVODEX EYE OINTMENT | N/A | N/A | N/A | 10/22/2024 | |
| DEXMETHA TAB 0.5MG | N/A | synco (h.k.) limited | N/A | N/A | 4/18/1979 |
| DEXAMETHASONE TABLET 0.5MG | N/A | synco (h.k.) limited | N/A | N/A | 12/28/1998 |
| TOBESON OPHTHALMIC SOLUTION 0.3/0.1% W/V | N/A | N/A | N/A | 9/2/2016 | |
| MAXITROL OPHTH SUSP | N/A | N/A | N/A | 2/5/1982 | |
| MAXITROL OPHTH OINT | N/A | N/A | N/A | 3/10/1982 | |
| MAXIDEX OPHTH SUSP 0.1% | N/A | N/A | N/A | 2/5/1982 | |
| TOBRADEX OPHTHALMIC SUSP | N/A | N/A | N/A | 4/2/1990 |
TGA Drug Approvals
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