Molnupiravir STELLA 400 mg

Rx

Indications:

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:

Adults:

• The recommended dose: 800 mg (2 capsules) molnupiravir is taken orally every 12 hours for 5 days.
• The safety and efficacy of molnupiravir when administered for periods longer than 5 days have not been established. Molnupiravir should be administered as soon as possible after a diagnosis of Covid-19 has been made and within 5 days of symptom onset.

Missed dose:

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

• Molnupiravir is not used for longer than 5 consecutive days.
• Molnupiravir is not used for pre-exposure or post-exposure prophylaxis for prevention of Covid-19.
• Molnupiravir is not used in patients less than 18 years of age.

Elderly: No dose adjustment of molnupiravir is required based on age.

Renal impairment, hepatic impairment: No dose adjustment is required for patients with renal impairment.

Paediatric population: The safety and efficacy of molnupiravir in patients below 18 years of age have not been established. No data are available. Molnupiravir is not recommended for use in this population.

Usage:

For oral use, it can be taken 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.

Hypersensitivity to the molnupiravir or to any of the excipients.

Nervous sytem disorders:

• Common: Dizziness, headache.

Gastrointestinal disorders:

• Common: Diarrhoea, nausea.
• Uncommon: Vomiting.

Skin and subcutaneous tissue disorders:

• Uncommon: Rash, urticaria.

• 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.