Dexamethasone Description
Dexamethasone is a corticosteroid that has been used since the 1960s to reduce inflammation in various conditions, including inflammatory disorders and certain cancers. Dexamethasone has been listed on the WHO Model List of Essential Medicines since 1977 in multiple formulations and is currently off-patent and affordably available in most countries.
Dexamethasone, a corticosteroid, is similar to a natural hormone produced by your adrenal glands. It often is used to replace this chemical when your body does not make enough of it. It relieves inflammation (swelling, heat, redness, and pain) and is used to treat certain forms of arthritis; skin, blood, kidney, eye, thyroid, and intestinal disorders (e.g., colitis); severe allergies; and asthma. Dexamethasone may cause side effects.
Dexamethasone solution for injection 4mg/ml in 1ml ampoules, manufactured by Kern Pharma SL, Spain, has been WHO prequalified for its use in the management of diseases associated with HIV/AIDS. WHO recommends that patients who have severe or critical COVID-19 receive corticosteroids.
Dexamethasone has been marketed in different formulations (e.g., tablets, liquid, solution for injection). The most common formulations are: Tablets: 0.5mg, 0.75mg, 1mg, 1.5mg, 2mg, 4mg and 6mg; Oral Solution: 0.5mg/5ml, 20mg/5ml and 1mg/ml (concentrate); Injectable suspension: 4mg/ml, 20mg/5ml.
Dexamethasone Indication
On June 8, 2022, the EMA adopted a list of critical medicines for COVID-19, which includes Dexamethasone. An update published in the NEJM on July 17, 2020, stated the preliminary results show that among hospitalized patients with Covid-19, the use of dexamethasone for up to 10 days resulted in lower 28-day mortality than usual care in patients who were receiving invasive mechanical ventilation at randomization (by 12.3 age-adjusted percentage points, a proportional reduction of approximately one third) and those who were receiving oxygen without invasive mechanical ventilation (by 4.1 age-adjusted percentage points, a proportional reduction of approximately one fifth). However, there was no evidence that dexamethasone provided any benefit among patients who were not receiving respiratory support at randomization, and the results were consistent with possible harm in this subgroup.
Dexamethasone Dosage
Dexamethasone comes as a tablet and a solution to take by mouth. Your doctor will prescribe a dosing schedule that is best for you. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dexamethasone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Dexamethasone News
February 25, 2021 - The NEJM published an ORIGINAL ARTICLE - Dexamethasone in Hospitalized Patients with Covid-19. In patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support. (Funded by the Medical Research Council and National Institute for Health Research and others; RECOVERY ClinicalTrials.gov number, NCT04381936; ISRCTN number, 50189673.
July 21, 2020 - Japan updates the Ministry of Health, Labor, and Welfare handbook to approve Dexamethasone for treating COVID-19 patients.
July 17, 2020 - A new study published in NEJM found patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support.
June 22, 2020 - Recovery Results: 2104 patients randomly allocated to receive dexamethasone were compared with 4321 patients concurrently allocated to usual care. Overall, 454 (21.6%) patients allocated dexamethasone and 1065 (24.6%) patients allocated usual care died within 28 days (age-adjusted rate ratio [RR] 0.83; 95% confidence interval [CI] 0.74 to 0.92; P<0.001).
June 16, 2020 - The World Health Organization (WHO) welcomes the initial clinical trial results from the United Kingdom (UK) that show dexamethasone, a corticosteroid, can be lifesaving for patients who are critically ill with COVID-19.
February 7, 2020 - Dexamethasone Treatment for the Acute Respiratory Distress Syndrome: A Multicentre, Randomised Controlled Trial.
March 27, 2019 - The Effect of Corticosteroids on Mortality of Patients With Influenza Pneumonia: A Systematic Review and Meta-Analysis.
Dexamethasone Clinical Trials
Clinical Trial NCT04381936: Randomised Evaluation of COVID-19 Therapy (RECOVERY) - last updated July 7, 2020.
- RECOVERY is a randomized trial investigating whether treatment with either Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin, Convalescent plasma or Tocilizumab prevents death in patients with COVID-19.