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• Product Name: Molnupiravir
• Content: Molnupiravir 200 mg/Cap
• Medicine Shape: Orange capsule printed with “82.
• Applicant: To be prescribed to adult patients with mild-to-moderate COVID-19 at high risk of severe disease, aged 18 years of age and older, have not used oxygen therapy and have onset within 5 days. For patients who could not use other recommended drugs.

Administration and Dosage

• Capsule-based dosage. Take 4 tables every 12 hours (e.g. 8 A.M. and 8 P.M.). Take twice a day and for 5 days.
• Take the medicine with or without meal. Take the whole capsule. Do not chew, separate or crush the capsule. Do not alter the dosage or suspend medication without the authorization under doctor instructions.
• If a dose is missed within 10 hours of the scheduled dosing time, take the missed dose as soon as possible and continue the regular dosing schedule. If more than 10 hours have passed, skip the missed dose and take the next dose at the scheduled time. Do not double the dosage.

Advantage/Disadvantage of Treatment

• Clinical investigation suggests that taking the preceding oral antiviral medicine could help shortening the course of disease, alleviate disease severity and lower mortality rate. However, the effect of medicine is not 100% effective and it is possible that you could experience worsening symptoms or new symptoms from the treatment.

Storage Instruction

• Please store the medicine with the medicine bag in an airtight container under room temperature and dry place. Avoid sunlight or place accessible to children.

Potential Adverse Reactions

• Diarrhea, nausea, dizziness, and possible serious and unexpected side effect.

Precautions

• No dosage adjustment is required for patients with renal or hepatic impairment or for elderly patients.
• Sexually active males with partners who may become pregnant should use effective contraception during therapy and for at least 3 months after the last molnupiravir dose.
• Complete the full 5-day course of molnupiravir even if your symptoms improve. Do not stop the medication early.
• Breastfeeding is not recommended during treatment with molnupiravir and for 4 days after the last dose.

Other Precautions

• To ensure full treatment effectiveness, do not stop taking the medication even if your symptoms improve.
• Clinical experience with molnupiravir is limited. Serious or unexpected adverse reactions may occur. If you notice any unusual, persistent, or worsening symptoms, please contact your physician or pharmacist.
• This medicine is authorized for emergency use (EUA). Therefore, adverse reactions that result in death, disability, or serious illness are not eligible for compensation under the Drug Injury Relief Act.

Recommendation for Oral Suspension (Patients who could not take oral medicine but have the need for medication)

Disclaimer: The effect of molnupiravir as an oral suspension has not been evaluated in clinical studies. In clinical studies, molnupiravir was administered orally every 12 hours.

According to Phase II clinical study data (MOVe-IN/MK-4482-001), only five subjects received molnupiravir via nasogastric or orogastric tube. However, the Chinese labeling for molnupiravir does not recommend this route of administration.

Please refer to the following clinical investigation (MOVe-IN/MK-4482-001) for administering molnupiravir through Nasogastric/orogastric tubing.

1. Open the four capsules and place the contents into the mixing container or syringe.
2. Add 40 mL of water.
3. Mix or stir the capsule contents thoroughly for 3 minutes. Administer the medicine immediately after preparation.

• It is recommended to administer the suspension to the patient within 1 hour after preparation.
• If the medicine is not administered immediately after preparation, re-mix the oral suspension for 1 minute before administering.
• Give up to 240 mL of water to ensure the full dose is swallowed.