MOLRAVIR 400

MOLRAVIR 400

202202-0206 • 116709 Views • Box of 02 blisters x 10 capsules and 1 package insert.
COMPOSITION

Each capsule MOLRAVIR 400 contains:

Active ingredient:

Molnupiravir  400 mg

Excipients: Pregelatinized starch, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, sodium lauryl sulfate, size 0 capsule, pink cap, pink body imprinted “BOSTON” in black (Gelatin, purified water, tartrazine, patent blue V, ponceau 4R, mica-based titanium dioxide).

Treatment of mild-to-moderate coronavirus disease 2019 (COVID- 19) in adults who have positive results of direct SARS-CoV-2 viral testing and have at least 1 high-risk factor for progression to severe COVID-19.

DOSAGE AND ADMINISTRATION

Administration

Oral administration, 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 not be opened, crushed or chewed.

Dosage

 Adult patients: 

- Recommended dose: 800 mg molnupiravir (2 capsules) taken orally every 12 hours for 5
days.

- The safety and efficacy of molnupiravir for use for longer than 5 consecutive days have not been established. 

Take molnupiravir as soon as possible after a diagnosis of COVID-19 has been made, and within 5 days of symptom onset.

Missing dose:

If the patient misses a dose of molnupiravir within 10 hours of the time it is usually taken, the patient should take it as soon as possible and resume the normal dosing schedule. 

If the patient misses a dose by more than 10 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. The patient should not double the dose to make up for a missed dose.

Limitations of authorized use 

Do not use for longer than 5 consecutive days.

Do not use for pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

Do not use for initiation of treatment in patients hospitalized due to COVID-19. Benefit of treatment with molnupiravir has not been observed in subjects when treatment was initiated after hospitalization due to COVID-19. 

The patient who has been starting treatment with molnupiravir before hospitalization may complete the full 5-day treatment course.

Special patients:

Elderly

No dose adjustment is necessary for elderly patients.

Renal impairment

No dose adjustment is necessary for patients with renal impairment.

Hepatic impairment

No dose adjustment is necessary for patients with hepatic impairment.

Children

The safety and efficacy of molnupiravir for use in patients less than 18 years old have not been established. No data is available for this patient population. It has not been authorized for use in patients less than 18 years old.

CONTRAINDICATIONS

Hypersensitivity to molnupiravir or to any of the excipients.

WARNINGS AND PRECAUTIONS

Warnings

There is limited clinical data available for molnupiravir. Serious and unexpected adverse events may occur that have not been previously reported with molnupiravir use.

Embryo-Fetal Toxicity

Based on findings from animal reproduction studies, molnupiravir may cause fetal harm when
administered to pregnant individuals. There are no available human data on the use of molnupiravir in pregnant individuals to evaluate the risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; therefore, molnupiravir is not recommended for use during
pregnancy. 

Advise individuals of childbearing potential of the potential risk to a fetus and to use an effective
method of contraception correctly and consistently, as applicable, during treatment with
molnupiravir and for 4 days after the final dose. 

Prior to initiating treatment with molnupiravir, assess whether an individual of childbearing potential is pregnant or not, if clinically indicated. Pregnancy status does not need to be confirmed in patients who have undergone permanent sterilization, are currently using an intrauterine system or contraceptive implant, or in whom pregnancy is not possible. In all other patients, assess whether the patient is pregnant based on the first day of the last menstrual period in individuals who have regular menstrual cycles, is using a reliable method of contraception correctly and consistently or has had a negative pregnancy test. A pregnancy test is recommended if the individual has irregular menstrual cycles, is unsure of the first day of the last menstrual period or is not using effective contraception correctly and consistently.

Bone and Cartilage Toxicity

Molnupiravir is not authorized for use in patients less than 18 years of age because it may affect bone and cartilage growth. Bone and cartilage toxicity was observed in rats after repeated dosing. The safety and efficacy of molnupiravir have not been established in pediatric patients.

Precautions

Females of reproductive potentials

Prior to initiating treatment with monupiravir, assess whether an individual of childbearing
potential is pregnant or not, if clinically indicated.

Advise individuals of childbearing potential to 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 potentials

It has not been established whether molnupiravir affects sperm. While the risk is regarded as low, nonclinical studies to fully assess the potential for m0lnupiravir to affect offspring of treated males have not been completed. Advise sexually active individuals with partners of childbearing potential to use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the last dose of molnupiravir.
The risk beyond three months after the last dose of molnupiravir is unknown. Studies to understand the risk beyond three months are ongoing.

Precautions with excipients

MOLRAVIR 400 contains tartrazine, patent blue V, ponceau 4R, which is potentially allergenic.

Each dosage 4 capsules per day contains less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium-free’

SHELF-LIFE 

6 months from the manufacturing date

 

 

Al/Al blister. Box of 01 blister x 10 capsules and 1 package insert.

Al/Al blister. Box of 02 blisters x 10 capsules and 1 package insert.

Al/Al blister. Box of 05 blisters x 10 capsules and 1 package insert.

 

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