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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 the medicine is not taken within the routine 10 hours, please take the medicine as soon as possible. If you forget to take the medicine after 10 hours, please omit the medication and start with next dosage. 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

• Currently the recommendation for dosage has not been adjusted for patients with renal insufficiency or hepatic insufficiency, or elderly patients.
• It is recommended that patients sexually active with partner with fertility shall correctly and continue to take reliable contraceptive measures during the treatment period and at least 3 months from the last dosage of molnupiravir.
• Before completing the entire 5-day treatment, even if you feel improvement of the disease, do not suspend the medication of molnupiravir.
• It is recommended not to breast feed during the treatment of taking molnupiravir or in 4 days after taking the last dosage of molnupiravir.

Other Precautions

• To ensure the healing efficacy, do not stop the medication if the symptoms become minor.
• There is limited information on the existing clinical data of molnupiravir. It is possible to have serious and unexpected adverse event never reported on precious use of molnupiravir. For any troubling, remittent and non-relieving side effects, please notify the physician or consult with the pharmacists.
• Emergency Use Authorizations (EUA) is provided for use by patients. Hence the adverse reaction after taking this medicine that leads to death, disability or serious disease will not be applicable for 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 administering molnupiravir through oral suspension to patients was not evaluated in clinical investigation. The administration in original investigation was one oral medication in every 12 hours.

According to the data on Phase II clinical investigation (MOVe-IN/MK-4482-001), only five subjects were administered molnupiravir through Nasogastric/orogastric tubing, but the instruction in Chinese version for molnupiravir did not recommend the administration through this mode.

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 content in the mixing container or syringe.
2. Add 40ml of water.
3. Mix/stir the content of capsule with after evenly for 3 minutes. After preparation, administer the medicine to patients as soon as possible.

• It is recommended to administer the suspension to patient no later than 1hour after preparation.
• If the medicine is not administered immediately after preparation, re-mix the oral suspension for 1 minute before administering.
• Give additional water to ensure all medicine has been swallowed, up to 240ml in water.