Mepira ®

Molnupiravir INN

Prescribing Details



Description

Mepira® is a preparation of Molnupiravir which is an antiviral drug. Molnupiravir is a prodrug that is metabolised to the ribonucleoside analogue N-hydroxycytidine (NHC) which distributes into cells where it is phosphorylated to form the pharmacologically active ribonucleoside triphosphate (NHC-TP). NHC-TP acts by a mechanism known as viral error catastrophe. NHC-TP incorporation into viral RNA by the viral RNA polymerase, results in an accumulation of errors in the viral genome leading to inhibition of replication.


Uses

No Data


Indications

Mepira® is indicated for treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness.


Dosage and administration

Route of administration: Mepira® is taken in oral route. It can be taken with or without food. The capsules should be swallowed whole with a sufficient amount of fluid (e.g., a glass of water). The capsules should not be opened, crushed or chewed.

Adults

The recommended dose of Mepira® is 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days.

The safety and efficacy of molnupiravir when administered for periods longer than 5 days have not been established. Mepira® should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset.

If the patient misses a dose of Mepira within 10 hours of the time it is usually taken, the patient should take as soon as possible and resume the normal dosing schedule. If a patient misses a dose by more than 10 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. The patient should not double the dose to make up for a missed dose.


Use in pregnancy & lactation

Pregnancy: Molnupiravir is not recommended during pregnancy. Women of childbearing potential should use effective contraception for the duration of treatment and for 4 days after the last dose of molnupiravir.

Lactation: Based on the potential for adverse reactions on the infant from molnupiravir, breastfeeding is not recommended during treatment and for 4 days after the last dose of molnupiravir.

Use in children and adolescents
The safety and efficacy of molnupiravir in patients below 18 years of age have not been established.


Geriatric use
No Data

Precautions

No information has been found.


Side effects

The most common side effects of molnupiravir are dizziness, headache, diarrhea, nausea, vomiting, rash and urticaria.


Contraindications

Molnupiravir is contraindicated in patients with known hypersensitivity to molnupiravir or any other components of this product.


Drug interactions

Drug interaction with medication: No drug interactions have been identified based on the limited available data.

Drug interaction with food and others: Not applicable.


Overdose

There is no human experience of overdose with molnupiravir. Treatment of overdose with molnupiravir should consist of general supportive measures including the monitoring of the clinical status of the patient. Haemodialysis is not expected to result in effective elimination of NHC.


Preparation

No Data


Pharmaceutical precautions

Store in a cool (below 30°C) and dry place protected from light. Keep away from the reach of children.


Presentation

Mepira® 200 Capsule: Each capsule contains Molnupiravir INN 200 mg.


Package quantities

Packing Mepira® 200 Capsule: Each carton contains 10 capsule in blister pack.