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Q&A: Dexamethasone and COVID-19 (Part 2)
New Delhi, June 26, 2020 ;
Dexamethasone was used in the Recovery Trial in oral (liquid or tablets) or intravenous preparation 6 mg once daily for ten days.
In pregnancy or breastfeeding women, prednisolone 40 mg administered by mouth (or intravenous hydrocortisone 80 mg twice daily) should be used instead of dexamethasone.
- Note: It is permitted to switch between the two routes of administration according to clinical circumstances.
Dexamethasone is generally safe. It presents a favourable benefit-risk profile, particularly in patients with severe forms of pneumonia, while the benefit is less prominent in patients with non-severe pneumonia. As the treatment is short, even at high doses, corticosteroids are not associated with serious side effects. Potentially higher blood glucose levels (hyperglycaemia) are temporary.
Prolonged use (I.e., used for more than two weeks) may be associated with adverse events such as glaucoma, cataract, fluid retention, hypertension, psychological effects (e.g., mood swings, memory issues, confusion or irritation), weight gain, or increased risk of infections and osteoporosis.
To reiterate: All these adverse events are not associated with short term use (with the exception of hyperglycaemia that can worsen diabetes).
The Recovery trial used dexamethasone 6mg daily oral or intravenous for ten days. Higher daily doses of dexamethasone have been used for other indications for a long time and are known to be safe.
They can be used in children and the elderly. In pregnancy, the Recovery trial used prednisolone orally or hydrocortisone by intravenous infusion instead of dexamethasone. Steroids are ubiquitous in terms of geographic use.
Yes. Dexamethasone is off-patent and has been marketed in different formulations (e.g., tablets, liquid, solution for injection) for many years. It is generally available in most countries. There are several manufacturers of the product. One manufacturer has already been prequalified by WHO (Kern Pharma in Spain) while another is under assessment.
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
In recent years there have been occasional reports of shortages of this product. It is important to quickly understand the projected volumes for COVID-19 utilization and manufacturing capacity to help assess the impact for existing indications and the potential need for substitute therapies, to ensure all patients retain access to a safe, effective, quality, affordable product to meet their therapeutic needs.
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