Generic Medicine Info
Indications and Dosage
Coronavirus disease 2019 (COVID-19)
Adult: For the treatment of mild to moderate cases in nonhospitalised patients with confirmed positive SARS-CoV-2 diagnostic test result who have at least 1 risk factor for developing severe COVID-19, and in whom alternative COVID-19 treatment options approved or authorised by the US FDA are inaccessible or not clinically appropriate: 800 mg 12 hourly for 5 days. Initiate therapy as soon as possible following diagnosis of COVID-19 and within 5 days of symptom onset. Safety and efficacy of therapy beyond 5 consecutive days have not been established. Missed dose: If a dose is missed within 10 hours of the time it is usually taken, take the missed dose as soon as possible then return to the normal dosing schedule. If the dose is missed by >10 hours, skip the missed dose and instead take the next dose at the usual dosing schedule. Do not double the dose to make up for a missed dose.
Child: <18 years Currently, the safety and efficacy of molnupiravir in children and adolescents have not been established; until such data are available, use in this age group is not recommended.
Elderly: Same as adult dose.
Special Precautions
Pregnancy (use only if potential benefits justify potential risks as data is limited regarding the use of molnupiravir in pregnant women). Breastfeeding is not recommended during therapy and for 4 days following the last dose.

It should be noted that:

- Use of molnupiravir for the treatment of COVID-19 have not been definitely established, some data are available from several initial clinical trials in the US and other countries.
- Molnupiravir may be available for use in some countries under emergency use authorisation (EUA) or conditional approval. Registration status and/or availability may vary between countries.
- The safety and efficacy of molnupiravir for the treatment of mild to moderate cases of COVID-19 continue to be evaluated. Preliminary clinical trial data showed that the use of molnupiravir early in the disease process when viral loads are high provided maximum benefit and reduced the risk of hospitalisation and/or death when given within 5 days of onset of symptoms.
- Currently available COVID-19 treatment guidelines recommend limiting the use of molnupiravir to nonhospitalised patients with mild to moderate cases who are at high risk of disease progression and are unable to use other available medications. If the patient requires hospitalisation after treatment initiation, the remainder of the full 5-day treatment course may be completed per the discretion of the healthcare provider.
- Molnupiravir is not indicated for use as pre-exposure or postexposure prophylaxis of COVID-19.
- Completion of the recommended full 5-day treatment course and continued isolation in accordance with the local public health guidelines are important to maximise viral clearance and minimise SARS-CoV-2 transmission.

For healthcare professionals:

- Refer to the local health authority for the most up-to-date information when prescribing molnupiravir.
- No specific drug-drug interaction data are available. Minimise any unnecessary co-medication whenever possible given the lack of information about interaction risk.
- To alleviate the risks of this unapproved drug during pandemic use, local regulatory agencies may require healthcare providers to comply with certain regulations on the use of molnupiravir. Please refer to respective local regulatory agencies for further information.
Adverse Reactions
Significant: Hypersensitivity reactions, including anaphylaxis and angioedema.
Gastrointestinal disorders: Nausea, diarrhoea, vomiting.
Nervous system disorders: Dizziness, headache.
Skin and subcutaneous tissue disorders: Rash, urticaria.
PO: Z (Animal studies showed reproductive and developmental toxicity. Not recommended during pregnancy.)
Patient Counseling Information
Women of childbearing potential must use a reliable birth control method during treatment and for 4 days after the last dose. Men with partners of childbearing potential must use a proven birth control method during treatment and for at least 3 months following the last dose.
Monitoring Parameters
Verify pregnancy status before treatment initiation in women of childbearing potential, if clinically indicated.
Description: Molnupiravir is an investigational antiviral prodrug with activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is hydrolysed during or after absorption to form the ribonucleoside analogue, N-hydroxycytidine (NHC), which enters into cells where it is further phosphorylated to the pharmacologically active ribonucleoside triphosphate (NHC-TP). NHC-TP incorporates into the ribonucleic acid (RNA) of SARS-CoV-2 by the viral RNA polymerase, resulting in the accumulation of errors in the viral genome and subsequent prevention of virus replication.
Absorption: Time to peak plasma concentration: 1-1.75 hours (NHC).
Distribution: Volume of distribution: 142 L.
Metabolism: Metabolised by carboxylesterases to NHC, which undergoes further phosphorylation to form the pharmacologically active NHC-TP.
Excretion: Via urine (≤3% as NHC). Elimination half-life: Approx 3.3 hours (NHC).
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 145996610, EIDD-2801. Accessed Feb. 22, 2022.

Store between 15-30°C.
MIMS Class
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Anon. Molnupiravir. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 08/02/2022.

Conditions of Use, Conditions for Distribution and Patients Targeted and Conditions for Safety Monitoring Addressed to Member States for Lagevrio (Molnupiravir). European Medicines Agency [online]. Accessed 08/02/2022.

Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults. U.S. FDA. Accessed 09/02/2022.

COVID-19 Treatment Guidelines: Therapeutic Management of Nonhospitalized Adults with COVID-19. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Accessed 10/02/2022.

EMA Issues Advice on Use of Lagevrio (Molnupiravir) for the Treatment of COVID-19. European Medicines Agency [online]. Accessed 08/02/2022.

Fact Sheet for Healthcare Providers: Emergency Use Authorization for Molnupiravir. U.S. FDA. Accessed 16/02/2022.

Joint Formulary Committee. Molnupiravir. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. Accessed 08/02/2022.

Lagevrio 200 mg Hard Capsules (Merck Sharp & Dohme [UK] Limited). MHRA. Accessed 08/02/2022.

Molnupiravir Capsule (Merck Sharp & Dohme Corp.). DailyMed. Source: U.S. National Library of Medicine. Accessed 08/02/2022.

Molnupiravir. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. Accessed 09/02/2022.

Disclaimer: This information is independently developed by MIMS based on Molnupiravir from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by
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