Moluzak-200 (Molnupiravir) caps. 200 mg №40

Basic Information

Pharmacological Properties

Molnupiravir is a prodrug with antiviral activity against SARS-CoV-2.
In the body, it is converted into NHC — a cytidine nucleoside analogue. Inside the cells, NHC is phosphorylated to form the active ribonucleoside triphosphate NHC-TP.

NHC-TP is incorporated into SARS-CoV-2 RNA by the viral RNA polymerase, causing accumulation of errors in the viral genome.
This mechanism of action is known as viral error catastrophe or lethal mutagenesis, resulting in inhibition of further viral replication.

Antiviral Activity

The molnupiravir metabolite NHC demonstrated activity in cell cultures against SARS-CoV-2.
According to studies, activity was also observed against SARS-CoV-2 variants Alpha, Beta, Gamma, and Delta.

NHC retained activity against viruses with polymerase substitutions associated with reduced sensitivity to remdesivir, indicating no cross-resistance.

Indications

Molnupiravir is indicated for the treatment of mild to moderate COVID-19 in adult patients with positive testing for SARS-CoV-2 who are at high risk of progression to severe disease, including hospitalization or death.

Limitations of Use

• Not approved for patients under 18 years of age.
• Not intended for pre-exposure or post-exposure prophylaxis of COVID-19.
• Not recommended for use longer than 5 consecutive days.
• Not intended for initiation of treatment in patients requiring hospitalization due to COVID-19.

Dosage and Administration

The recommended dose for adults is 800 mg, which equals 4 capsules of 200 mg, taken orally every 12 hours for 5 days.
The medicine may be taken with or without food.

Treatment should be initiated as soon as possible after diagnosis of COVID-19 and within 5 days after symptom onset.
It is important to complete the full 5-day course of treatment.

Pharmacokinetics

Molnupiravir is a prodrug that is converted after absorption into NHC — the primary circulating metabolite.
NHC enters cells and is transformed into the active form NHC-TP. Elimination occurs mainly through metabolism to uridine and/or cytidine.

Special Patient Groups

Elderly Patients

Dose adjustment based on age is not recommended. Clinical studies showed no significant differences in safety and tolerability between patients aged 65 years and older and younger adults.

Renal Impairment

Dose adjustment is generally not required in patients with renal impairment. Renal clearance is not a major elimination pathway for NHC.

Hepatic Impairment

Dose adjustment is generally not required in patients with hepatic impairment because hepatic elimination is not considered the primary elimination pathway for NHC.

Pediatric Use

Molnupiravir is not indicated for patients under 18 years of age because safety and efficacy have not been established in children.

Contraindications

Based on currently available data, no specific contraindications have been identified for molnupiravir.
However, the medicine should only be used after consultation with a healthcare professional considering the patient’s condition, concomitant diseases, and possible risks.

Adverse Reactions

The most commonly reported adverse reactions in clinical studies included:

• diarrhea;
• nausea;
• dizziness.

These reactions were generally mild or moderate in severity. Other adverse reactions may also occur; therefore, medical attention should be sought if symptoms worsen.

Use During Pregnancy and Lactation

Molnupiravir is not recommended during pregnancy because animal studies suggest potential risk to the fetus.
Before starting treatment, pregnancy status should be evaluated in individuals of reproductive potential when clinically indicated.

During treatment and for 4 days after the last dose, women of reproductive potential are advised to use effective contraception.
Men with partners of reproductive potential are advised to use reliable contraception during treatment and for at least 3 months after the last dose.

Breastfeeding is not recommended during treatment with molnupiravir and for 4 days after the last dose.

Drug Interactions

According to in vitro studies, molnupiravir and its metabolite NHC are not significant substrates or inhibitors of major CYP enzymes and transporters.
No clinically significant drug interactions have been identified; however, concomitant use with other medicines should be discussed with a healthcare professional.

Overdose

Human experience with molnupiravir overdose is limited.
In case of overdose, general supportive measures and monitoring of the patient’s clinical condition are recommended.

Storage Conditions

Store molnupiravir capsules at 20–25 °C in a dry place out of reach of children.