Monulamax 200 is an antiviral prodrug which has an activity against SARS Cov-2. It has a molecule called molnupiravir, which is a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis and is the 5 ́-isobutyrate ester of the ribonucleoside analog N4- hydroxycytidine (NHC).

Monulamax metabolize the cytidine nucleoside analogue NHC, which distributes into cells where NHC is phosphorylated to form the pharmacologically active ribonucleoside triphosphate (NHC-TP). NHC-TP incorporation (as NHC-monophosphate [NHC-MP]) into SARS-CoV-2 RNA by the viral RNA polymerase (nsp12) results in an accumulation of errors in the viral genome leading to inhibition of replication. The mechanism of action (known as viral error catastrophe or viral lethal mutagenesis) is supported by biochemical and cell culture data.

Each Capsule of Monulamax 200 contains Molnupiravir 200 mg. The other ingredients include Crospovidone, Povidone K-30, Microcrystalline cellulose, Colloidal silicon dioxide, Sodium stearyl fumarate.

• Adult - 800 mg (four 200 mg capsules) orally every 12 hours for 5 days, with or without food. Monulamax 200 should be administered as soon as possible and within 5 days of symptom onset.
• Completion of the full 5-day treatment course and continued isolation in accordance with public health recommendations are important to maximize viral clearance and minimize transmission of SARS-CoV-2. The patient may complete the full 5-day treatment course as per the healthcare provider’s direction.
• No dosage adjustment is recommended based on renal or hepatic impairment or in geriatric patients.

Monulamax 200 is recommended for the treatment of adult patients with COVID-19, with SpO2˃93% and who are at a high risk of progression of disease including hospitalization or death.

The use of Monulamax 200 is restricted in the following conditions:

• Individuals less than 18 years of age
• Pregnant women
• As initial treatment in COVID-19 patients who require immediate hospitalization .
• For use for longer than 5 consecutive days
• For pre-exposure or post-exposure prophylaxis for prevention of COVID-19
• Females of childbearing potential should use a reliable method of contraception correctly and consistently, as applicable, for the duration of treatment and for 4 days after the last dose of molnupiravir.
• Males of reproductive potential who are sexually active with females of childbearing potential should use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the last dose

The healthcare providers must assess and recommend the following conditions prior to prescribing Monulamax 200:

• Whether or not a female of childbearing potential is pregnant.
• Whether an individual is above 18 years of age
• Lactating women- Breastfeeding should be interrupted during treatment and for 4 days after the last dose of Monulamax 200
• Use a reliable method of contraception correctly and consistently for females of childbearing potential

The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all medication errors and serious adverse events.

Diarrhea, nausea, and dizziness are the most common adverse reaction.

No contraindications have been identified based on the available data.

No drug interactions have been identified based on the available data.

There is no human experience of overdosage with Monulamax 200 so far. However, the treatment for overdose should consist of general supportive measures including the monitoring of the clinical status of the patient.

Studies did not show any difference in safety and tolerability between patients above 65 years of age and younger patients who were treated with molnupiravir.

No dosage adjustment is recommended based on age. The PK of NHC is similar in geriatric patients compared to younger patients.