Dexamethasone-Darnitsa is Indicated for Use in Severely Ill Patients with COVID-1904 February 2021
Pursuant to the Order of the Ministry of Health of Ukraine dated January 26, 2021, changes to the instruction for medical use of Dexamethasone-Darnitsa manufactured by “Darnitsa” Pharmaceutical Firm” PrJSC were approved. According to the introduced changes, Dexamethasone-Darnitsa, solution for injections, 1 ml/4 mg, is indicated for treatment of the coronavirus disease COVID-19 in patients who need additional oxygen therapy.
By the end of February 2021, “Darnitsa” Pharmaceutical Company expects the approval of the relevant changes to the instruction for medical use of Dexamethasone-Darnitsa, tablets, 0.5 mg.
Dexamethasone is a well-known drug with an established safety profile, which has a wide range of applications in the world for a number of indications. Dexamethasone was recognized as the world's first drug shown to be effective in reducing the risk of mortality in severely ill patients with COVID-19 based on positive results confirmed by the RECOVERY trial (NCT04381936) conducted by the University of Oxford.
Based on the results of the RECOVERY trial, the European Medicines Agency (EMA) approved the use of medicinal products containing Dexamethasone as the active ingredient in patients who need additional oxygen therapy or ALV due to complications of COVID-19.
According to recommendations of the ЕМА, Dexamethasone should be administered orally or intravenously in the form of injection or drop intravenous infusion. In all cases the recommended dose for adults and adolescents is 6 mg once a day for up to 10 days.
Pursuant to the recommendation of the European regulatory authority, “Darnitsa” Pharmaceutical Company introduced the following changes to the instruction for medical use of Dexamethasone-Darnitsa, solution for injections, 1 ml/4mg:
- in “Indications” section, information was added about the treatment of the coronavirus disease COVID-19 in adults and adolescent patients (of 12 years of age and older with body weight of at least 40 kg), who need additional oxygen therapy;
- “Pharmacological Properties” section was supplemented with the information about the RECOVERY trial;
- “Administration Details” section was supplemented with the information on the peculiarity of the use in patients who already take systemic (oral) corticosteroids for other reasons (e.g. patients with chronic obstructive pulmonary disease) and do not require additional oxygen;
- “Posology and Administration” section was supplemented with information “For treatment of COVID-19. To adults and children (adolescents of 12 years of age and older with body weight of at least 40 kg): 6 mg of Dexamethasone intravenously once a day in a cycle of up to 10 days. The duration of treatment shall be determined on a case by case basis in accordance with the clinical condition of the patient.”
As of February 2021, Dexamethasone remains the only medicinal product in the world which has shown a reduction in mortality among patients with COVID-19 who need additional oxygen therapy or artificial lung ventilation.
Dexamethasone is included in the current Guidelines “Provision of Medical Care for the Treatment of Coronavirus Disease (Covid-19)”, approved by the Order of the Ministry of Health of Ukraine.