Instructions for Esperavir (molnupiravir) 400 mg 20 capsules
treatment of new coronavirus infection (COVID-19) confirmed by the results of a diagnostic test for SARS-CoV-2
Description
Capsules are solid gelatin, size No. 0, body is white, cap is white, opaque, cylindrical shape with hemispherical ends; the contents of capsules are powder or a mixture of powder and granules from white to yellowish-white; the presence of conglomerates (lumps), decaying when pressed with a glass stick, may be in the form of a condensed mass in the form of a cylinder.
ATC Codes
J05AX Other antiviral drugs
Active substance
molnupiravir
Pharmacotherapeutic group Esperavir
Antiviral agent
Pharmacological effect molnupiravir
molnupiravir is a prodrug metabolized to the ribonucleoside analog N-hydroxycytidine (NHC). NHC is distributed into cells and phosphorylated to form pharmacologically active ribonucleoside triphosphate (NHC-TP).
Antiviral activity Esperavir
NHC in a cell culture experiment was active against SARS-CoV-2 with a 50% effective concentration (EK50) ranging from 0.67 to 2.66 μmol in A-549 cells and 0.32 to 2.03 μmol in Vero 6 cells.
NHC had similar activity against SARS-CoV-2 variants B.1.1.7 (Alpha), B.1351 (Beta), P.1 (Gamma) and B.1.617.2 (Delta) with EC50 values of 1.59, 1.77 and 1.32 and 1.68 μmol respectively.
The NHC antiviral activity against SARS-CoV-2 in vitro has not been affected in combination with other antiviral drugs (abacavir, emtricitabine, hydroxychloroquine, lamivudine, nelfinavir, remdevir, ribavirin, sofosbuvir, tenofovir).
The results of clinical trials showed that taking Esperavir® on 6-7 days of therapy leads to the elimination of the virus from the body.
Indications
- Suitable for treatment of novel coronavirus disease (COVID-19) confirmed by a diagnostic test for SARS-CoV-2.
- Mild and moderate cases in adults with an increased risk of progression to severe disease and no additional oxygen therapy is required.
Mode of application, course and dosage Esperavir
Esperavir® should be taken by mouth, without reference to meal times. Capsules should be swallowed whole, without disturbing their integrity - do not open, crush or chew.
For SARS-CoV-2 COVID-19, the following regimen is recommended for adult patients:
Four 200-mg capsules or two 400-mg capsules are taken twice a day (every 12 hours). Thus, the single dose is 800 mg, and the daily dose is 1600 mg. The duration of the therapy course is five days.
It is recommended to start treatment with Esperavir® as soon as possible after the diagnosis of COVID-19 has been confirmed and/or no later than five days after the onset of the first symptoms.
If the next dose is missed and less than 10 hours have passed since the scheduled time, the missed dose should be taken as soon as possible and the usual schedule should continue. If more than ten hours have passed, a missed dose should not be taken, and people should wait for the next scheduled dose. People should not take double doses to compensate for missing doses.