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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.

Molnupiravir Stella

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Lactation Support

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2,4-Dichlorobenzyl alcohol 1,2 mg

Amylmetacresol 0,6 mg

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Nasal spray for rhino-sinusitis.

Xoangspray

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Oral suspension

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Molnupiravir STELLA 400 mg

Oral antiviral, direct acting antivirals.
Function of the ingredient: Oral antiviral, direct acting antivirals.
Packaging: Box of 2 blisters x 10 hard capsules.
Expiry date: 08 months from manufacturing date.
Composition: Each hard capsule contains molnupiravir 400 mg.
Dosage form: Hard capsules.
Manufacturer: Stellapharm Joint Venture Company, Ltd. - Branch 1
Instructions for Use
Indication
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Treatment of mild to moderate 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
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For oral use. Take molnupiravir 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 be not be opened, crushed or chewed.

The recommended dose of molnupiravir is 800 mg (two 400 mg capsules) taken orally every 12 hours for 5 days.

Contraindication
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Hypersensitivity to the active substance or to any of the excipients.
Adverse reaction
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Nervous sytem disorders:

  • Common: Dizziness.

Gastrointestinal disorders:

  • Common: Diarrhoea, nausea.
Warnings and precautions
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  • There are limited clinical data available for molnupiravir. Serious and unexpected adverse events may occur that have not been previously reported with molnupiravir use.
  • Molnupiravir is not authorized for use in patients less than 18 years of age because it may affect bone and cartilage growth. The safety and efficacy of molnupiravir have not been established in pediatric patients.
  • 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.
  • Based on the potential for adverse reactions in the infant from molnupiravir, breastfeeding is not recommended during treatment with molnupiravir and for 4 days after the final dose. A lactating individual may consider interrupting breastfeeding and may consider pumping and discarding breast milk during treatment and for 4 days after the last dose of molnupiravir.
  • Sexually active individuals with partners 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 of molnupiravir.
  • This medicinal product contains less than 1 mmol sodium (23 mg) per dose of 2 capsules, that is to say essentially ‘sodium-free’.
  • No adequate information of the effects on the ability to drive and use machines is available.
Frequently Asked Questions
1. Does the use of Molnupiravir harm patients with underlying diseases (cancer, cardiovascular disease, diabetes, liver, kidney, ...) or affect the treatment of these diseases?
Assoc. Prof. PhD. Do Van Dung
Faculty of Public Health - University of Medicine and Pharmacy at Ho Chi Minh City - Co-Principal Investigator of clinical trial of molnupiravir:

It is a valuable thing that molnupiravir has few interactions with other drugs and it does not negatively affect the treatment of other diseases. Therefore, a COVID-19 patient who is hospitalized for another medical condition (eg, diabetes) and required a COVID-19 treatment (due to elderly or underlying medical conditions), he/she may and should still be prescribed Molnupiravir. Investigators at the University of Medicine and Pharmacy have experience in treating COVID-19 patients who are very old (99 years old) or have many underlying medical conditions. It is important to fully counsel the patient and their family members because in these individuals, severe disease development may not be due to molnupiravir or COVID-19 disease but advanced age or underlying medical conditions affecting the patient's clinical condition.

Cited from “Health magazine”: http://www.tcsuckhoe.com/thuoc-khang-virus-molnupiravir-va-nhung-luu-y-khi-su-dung/)

2. Who should take molnupiravir?
Assoc. Prof. Dr. Do Van Dung
Assoc. Prof. PhD. Do Van Dung - Faculty of Public Health - University of Medicine and Pharmacy at Ho Chi Minh City - Co-Principal Investigator of clinical trial of molnupiravir:

For optimal efficacy, Molnupiravir should be given to elderly COVID-19 patients (over 50 years), patients with underlying medical conditions, or unvaccinated patients. The latest COVID-19 treatment guidelines from the US in January 2022 also indicated the use of Molnupiravir for the above subjects.

Young patients and those without an immune can take Molnupiravir. Young patients without underlying disease and has developed immunity after vaccination or reinfection do not need to be treated with molnupiravir because the benefits do not outweigh the drug-associated potential risks. For the elderly, with underlying medical conditions, even if re-infected, treatment with molnupiravir is required, because this is a group with high risk factors.

(As cited from “Health magazine”: http://www.tcsuckhoe.com/thuoc-khang-virus-molnupiravir-va-nhung-luu-y-khi-su-dung/

3. What should be paid attention to when storing Molnupiravir?
Assoc. Prof. Dr. Do Van Dung
Dean of the Faculty of Public Health - Ho Chi Minh City Medicine and Pharmacy University - Co-chair of the Clinical Research Project of Molnupiravir replied:

In general, Molupiravir is highly stable and unaffected by light. Therefore, it is enough to just keep the medicine at a stable temperature of about 25°C and not more than 40°C.

(Source: Health Magazine - http://http//www.tcsuckhoe.com/thuoc-khang-virus-molnupiravir-va-nhung-luu-y-khi-su-dung/)

 
4. What are the differences between Molnupiravir and other antiviral drugs on the market?
Assoc. Prof. Dr. Do Van Dung
Dean of the Faculty of Public Health - Ho Chi Minh City Medicine and Pharmacy University - Co-chair of the Clinical Research Project of Molnupiravir replied:

To treat COVID-19 patients who do not need to be hospitalized, in addition to Molunpiravir, according to US FDA guidelines, there are 3 medicines that have been determined to be effective at reducing the risk of severe progression: Paxlovid (oral medicine), monoclonal antibodies and remdesivir (intravenous). However, these drugs are very rare in the Vietnamese market (Remdesivir is possible but in Vietnam only for inpatients because it requires intravenous infusion for 3 days).
Some other antiviral drugs currently available in Vietnam such as favipiravir (Avigan) and umifenovir (Arbinol) may also be effective, but the overall efficacy from studies is lower than that of molnupiravir and has not been included in the US regimen COVID-19 treatment guidelines.

(Source: Health Magazine - http://www.tcsuckhoe.com/thuoc-khang-virus-molnupiravir-va-nhung-luu-y-khi-su-dung/)

 
5. How safe is Molnupiravir based on results?
GONSA
GONSA - Specializing in Pharmaceuticals Services

Molnupiravir capsules have been clinically tested during the treatment of COVID-19 in the US and India with positive results. Through 3 phases of testing, molnupiravir has succeeded in effectively reducing the viral load with RT-PCR negative results on day 5 reaching 78.3% in the experimental group, compared with 48.4 % in the standard care group.
By the 10th and 14th day of treatment, the remaining patients had RT-PCR negative results. Not only clinical improvement, but the trial also showed an excellent recovery of the patient's health, and confirmed the safety of the drug, no side effects or illnesses were observed during and after duration of the treatments.
In Vietnam, the Ministry of Health also announced positive clinical trial results with 360 patients using this medicine in 2 trial phases. Specifically, 160 phase 1 participants showed positive results for safety, tolerability, and clearance or viral load reduction in patients with mild and moderate COVID-19 after 5 days of treatment.  As a result, hospitalization rates and mortality rates have also decreased significantly.

(Source: Health and Lifestyle Magazine - http://https//suckhoedoisong.vn/molnupiravir-thuoc-khang-virus-dau-tien-duoc-chung-minh-tinh-hieu-qua-voi-virus-sar-cov-2%20-169210826160603734.htm)

 
6. How should it be handled in case of overdose of Molnupiravir (due to forgetting to take the medicine, using it in the wrong way,...)?
Assoc. Prof. Dr. Do Van Dung
Dean of the Faculty of Public Health - Ho Chi Minh City Medicine and Pharmacy University - Co-chair of the Clinical Research Project of Molnupiravir replied:

In case of overdose, medical staffs will closely monitor vital signs (temperature, heart rate, breathing rate, blood pressure, SpO2) and provide supportive treatment if there are problems.

(Sources: Health Magazine - http://http//www.tcsuckhoe.com/thuoc-khang-virus-molnupiravir-va-nhung-luu-y-khi-su-dung/)%20%E2%80%8B

7. Why is Molnupiravir prescribed to take 12 hours apart and 1 hour before eating?
Assoc. Prof. Dr. Do Van Dung
Dean of the Faculty of Public Health - Ho Chi Minh City Medicine and Pharmacy University - Co-chair of the Clinical Research Project of Molnupiravir replied:

Molnupiravir is prescribed to be taken 12 hours apart from each dose, the effect will last about 16 hours (5 times the half-life of the drug is 3.3 hours). This medicine can be taken at any time, including on an empty stomach or after eating. Some doctors ask patients to drink before eating so that the patient can easily remember when to take the medicine.

(Source: Health Magazine -http://%20http//www.tcsuckhoe.com/thuoc-khang-virus-molnupiravir-va-nhung-luu-y-khi-su-dung/)%20%E2%80%8B

8. Molnupiravir has the ability to affect the genome of the virus, so long-term use will have an effect on users. Is this correct?
Dr. Truong Huu Khanh
Dr. Truong Huu Khanh - Standing Vice President of Infectious Diseases Association of Ho Chi Minh City replied:
Molnupiravir is unlikely to affect the viral genome. Molnupiravir's mechanism is that when the viral RNA is released and inserted into the human ribosome to produce proteins, Molnupiravir will combine with the viral RNA and make the viral RNA can not attach to the human ribosome, thus inhibiting the spreading of virus in our body. (Source: Health Magazine - http://http//www.tcsuckhoe.com/molnupiravir-duoi-goc-nhin-chuyen-gia-dich-te/%20)
9. Is it possible to split/cut/destroy the capsule shell of the pill to help the patient to easily use?
Assoc. Prof. Dr. Do Van Dung
Dean of the Faculty of Public Health - Ho Chi Minh City Medicine and Pharmacy University - Co-chair of the Clinical Research Project of Molnupiravir replied:

According to the instructions of the prescription, the capsule should not be cut or destroyed to facilitate optimal absorption and to avoid contaminating molnupiravir to others (especially children). However, if there is a COVID-19 patient at risk of severe progression, who needs to be treated with Molnupiravir and cannot swallow the pill, the capsule can be opened or cut to allow the patient to drink the clear powder, but be careful, so the others are not exposed to the medicine unintentionally.

(Source: Health Magazine - http://http//www.tcsuckhoe.com/thuoc-khang-virus-molnupiravir-va-nhung-luu-y-khi-su-dung/)

 
10. Is the manufacturer reputable or not?
GONSA
GONSA - Specializing in Pharmaceuticals Services

The manufacturer of Molnupiravir Stella 400 mg is Stellapharm Joint Venture Company Limited, established in 2000 (formerly STADA - Vietnam Joint Venture Co., Ltd.), currently the leading pharmaceutical manufacturing enterprise in the field of export pharmaceutical production in Vietnam, especially the European market (SRA).
Stella's products quality has been globally recognized through the assessment and recognition of pharmaceutical authorities around the world such as the European Medicines Agency (EMA), the Japan Pharmaceutical and Medical Devices Agency (PMDA), Taiwan Food and Drug Administration (Taiwan FDA), World Health Organization (WHO) and others. Stella products are now trusted by millions of patients in more than 50 countries worldwide.

(Source: Stella Vietnam - https://www.stelapharm.com/en/about/)

 
11. During the time of treatment with Molnupiravir, should I use other medicines (Western or Eastern medicine) to enhance the treatment effect?
Assoc. Prof. Dr. Do Van Dung
Dean of the Faculty of Public Health - Ho Chi Minh City Medicine and Pharmacy University - Co-chair of the Clinical Research Project of Molnupiravir replied:

According to international guidelines and data from studies, treatment with molnupiravir does not require and should not be treated with other antivirals, antibiotics or corticosteroids. It is possible to use some medicines to treat symptoms such as antipyretic, cough drops or supplement with vitamins (C, D) and trace elements (such as Zinc). Oriental medicines to treat symptoms can also be used. However, it is necessary to understand the composition of oriental medicines before using them because some of them may have some active ingredients that have an adverse effect on immunity.

(Source: Health Magazine -http://%20http//www.tcsuckhoe.com/thuoc-khang-virus-molnupiravir-va-nhung-luu-y-khi-su-dung/)

 
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