Molnupiravir Capsules 200 mg [200 Mg Molnupiravir, Prescription, Treatment: Covid 19], Omicron a COVID-19 variant

Molnupiravir Capsules 200 mg [200 Mg Molnupiravir, Prescription, Treatment: Covid 19]

Molnupiravir (development codes MK-4482 and EIDD-2801) is an experimental antiviral drug which is orally active and was developed for the treatment of influenza. It is a prodrug of the synthetic nucleoside derivative N4-hydroxycytidine, and exerts its antiviral action through introduction of copying errors during viral RNA replication.

The drug was developed at Emory University by the university's drug innovation company, Drug Innovation Ventures at Emory (DRIVE). It was then acquired by Miami-based company Ridgeback Biotherapeutics, who later partnered with Merck & Co. to develop the drug further.

Safety controversyIn April 2020, a whistleblower complaint by former Head of US Biomedical Advanced Research and Development Authority (BARDA) Rick Bright revealed concerns over providing funding for the further development of molnupiravir due to similar drugs having mutagenic (DNA damaging) properties.[3] A previous company, Pharmasset, that had investigated the drug's active ingredient had abandoned it. These claims were denied by George Painter, CEO of DRIVE, noting that toxicity studies on molnupiravir had been carried out and data provided to regulators in the US and UK, who permitted safety studies in humans to move forward in the spring of 2020. Also at this time, DRIVE and Ridgeback Biotherapeutics stated they planned future safety studies in animals.

COVID-19In late July 2020 Merck, which had been partnering with Ridgeback Biotherapeutics on developing the drug, announced its intention to move molnupiravir to late stage trials beginning in September 2020. On October 19 2020, Merck began a one year Stage 2/3 trial focused on hospitalized patients.

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Is Omicron a COVID-19 variant of concern?
Does the Omicron variant of COVID-19 cause severe illness?
Have cases of COVID-19 variant Omicron been mild so far?
What are the organs most affected by COVID‐19?

Molnupiravir (Taj Pharma) is indicated for 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 (see sections 4.2 and 5.1 for information on posology and limits of clinical trial population).

The recommended dose of Molnupiravir (Taj Pharma) is 800 mg (four 200 mg capsules) 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 (see section 5.1).

Molnupiravir (Taj Pharma) should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset (see section 5.1).

Missed dose

If the patient misses a dose of Molnupiravir (Taj Pharma) 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.

Special populations

Elderly

No dose adjustment of Molnupiravir (Taj Pharma) is required based on age (see section 5.2).

Renal impairment

No dose adjustment is required for patients with renal impairment (see section 5.2).

Hepatic impairment

No dose adjustment is required for patients with hepatic impairment (see section 5.2).

Paediatric population

The safety and efficacy of Molnupiravir (Taj Pharma) in patients below 18 years of age have not been established. No data are available (see section 5.1).

Method of administration

For oral use.

Molnupiravir (Taj Pharma) 200 mg capsules 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

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose of 4 capsules, that is to say essentially 'sodium-free'.

4.5 Interaction with other medicinal products and other forms of interaction

No drug interactions have been identified based on the limited available data. No clinical interaction studies have been performed withmolnupiravir. Molnupiravir is hydrolysed to n-hydroxycytidine (NHC) prior to reaching systemic circulation. Uptake of NHC and metabolism to NHC-TP are mediated by the same pathways involved in endogenous pyrimidine metabolism. NHC is not a substrate of major drug metabolising enzymes or transporters. Based on in vitro studies, neither molnupiravir nor NHC are inhibitors or inducers of major drug metabolising enzymes or inhibitors of major drug transporters. Therefore, the potential for molnupiravir or NHC to interact with concomitant medications is considered unlikely.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no data from the use of Molnupiravir (Taj Pharma) in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).

Molnupiravir (Taj Pharma) 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 (Taj Pharma) (molnupiravir).

Breast-feeding

It is unknown whether molnupiravir or any of the components of molnupiravir are present in human milk, affect human milk production, or have effect on the breastfed infant. Animal lactation studies with molnupiravir have not been conducted.

Based on the potential for adverse reactions on the infant from Molnupiravir (Taj Pharma), breast-feeding is not recommended during treatment and for 4 days after the last dose of Molnupiravir (Taj Pharma).

Fertility

There were no effects on female or male fertility in rats at NHC exposures approximately 2 and 6 times respectively, the exposure in humans at the recommended human dose (RHD) (see section 5.3).

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Summary of safety profile

In an interim analysis of a Phase 3 trial of subjects with mild to moderate COVID-19 treated with molnupiravir (n=386), the most common adverse reactions (≥1% of subjects) reported during treatment and during 14 days after the last dose were diarrhoea (3%), nausea (2%), dizziness (1%) and headache (1%) all of which were Grade 1 (mild) or Grade 2 (moderate).

Tabulated list of adverse reactions

The adverse reactions are listed below by system organ class and frequency. Frequencies are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000).

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