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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/08/08 | Phase 4 | Recruiting | Hospital for Special Surgery, New York | ||
2023/08/08 | Phase 1 | Recruiting | Abdullah Khan | ||
2023/08/07 | Phase 2 | Recruiting | |||
2023/08/03 | Phase 4 | Completed | |||
2023/08/03 | N/A | AVAILABLE | |||
2023/07/28 | Phase 3 | Withdrawn | |||
2023/07/14 | Not Applicable | Completed | Gujranwala medical college District Headquarters Hospital, Gujranwala | ||
2023/07/13 | Phase 2 | Recruiting | Shandong University | ||
2023/07/07 | Not Applicable | Recruiting | shifeng Lou | ||
2023/07/06 | Phase 2 | Recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Mylan Institutional LLC | 67457-419 | INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE | 4 mg in 1 mL | 11/4/2019 | |
| Xspire Pharma, Llc | 42195-121 | ORAL | 1.5 mg in 1 1 | 1/18/2022 | |
| Amneal Pharmaceuticals LLC | 70121-1399 | INTRAMUSCULAR, INTRAVENOUS | 10 mg in 1 mL | 12/25/2023 | |
| NuCare Pharmaceuticals,Inc. | 68071-2418 | OPHTHALMIC | 1 mg in 1 mL | 5/26/2021 | |
| Proficient Rx LP | 63187-383 | ORAL | 2 mg in 1 1 | 1/1/2021 | |
| Alvogen Inc. | 47781-916 | ORAL | 6 mg in 1 1 | 5/31/2021 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1297 | SOFT TISSUE, INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS | 4 mg in 1 mL | 1/30/2024 | |
| Stat Rx USA | 16590-068 | OPHTHALMIC | 1 mg in 1 mL | 10/27/2009 | |
| Amneal Pharmaceuticals of New York LLC | 53746-831 | AURICULAR (OTIC) | 1 mg in 1 mL | 3/26/2024 | |
| Apotex Corp. | 60505-6253 | ORAL | 2 mg in 1 1 | 3/8/2024 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Dexamethasone Sodium Phosphate Injection | 国药准字H37020059 | 化学药品 | 注射剂 | 9/4/2020 | |
| Dexamethasone Sodium Phosphate Injection | 国药准字H21022402 | 化学药品 | 注射剂 | 8/18/2020 | |
| Dexamethasone Sodium Phosphate Injection | 国药准字H53020671 | 化学药品 | 注射剂 | 9/28/2020 | |
| Dexamethasone Sodium Phosphate Injection | 国药准字H34023513 | 化学药品 | 注射剂 | 1/7/2021 | |
| Dexamethasone Sodium Phosphate Injection | 国药准字H52020794 | 化学药品 | 注射剂 | 8/19/2020 | |
| Dexamethasone Sodium Phosphate Injection | 国药准字H33021587 | 化学药品 | 注射剂 | 6/12/2020 | |
| Dexamethasone Sodium Phosphate Injection | 国药准字H50021462 | 化学药品 | 注射剂 | 11/9/2020 | |
| Dexamethasone Sodium Phosphate Injection | 国药准字H22020043 | 化学药品 | 注射剂 | 11/2/2021 | |
| Dexamethasone Sodium Phosphate Injection | 国药准字H33020594 | 化学药品 | 注射剂 | 5/22/2020 | |
| Dexamethasone Sodium Phosphate Injection | 国药准字H42022049 | 化学药品 | 注射剂 | 6/14/2022 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||