Virso and Dactovin 12 Weeks

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BRAND :  VIRSO & DACTOVIN PRICE :  750$ STRENGTH : 400MG ACTIVE :  VIRSO-SOFOSBUVIR-400MG-DACTOVIN-DACLATASVIR-60MG-12WEEKS COMPANY NAME :  STRIDES TABLETS :  28... read more

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Drug profile

Virso Dactovin tablets are anti-viral medication, containing two most predominant ingredients such as Sofosbuvir and Daclatasvir

Virso Dactovin tablets are single dose therapy, it is a prescription medicine used by the patients only under the knowledge of medical practitioner who are well practiced

Dactovin tablet is not used alone, for better action it should be combined with Virso tablet.

In some condition Virso Dactovin is combined with ribavirin, an anti-viral medicine used in decompensated (Child Pugh B or C) cirrhosis

 

Brand name: Virso Dactovin

Active components: Virso-Sofosbuvir, Dactovin-Daclatasvir

Strength of the components: 400mg & 60mg respectively

Mfg: Strides

Package: 28 tablets in a container

Category: Anti-hepaciviral drug

 

Prescribing information for Virso Dactovin

The main indication of Virso Dactovin is;

This combination tablets are used to treat the chronic hepatitis C viral infection caused by genotype I or III

The major limitation occurred while using Virso Dactovin tablets are reduction of constant virological response rate in hepatitis C genotype I or III infected patients.

 

Mechanism of Virso Dactovin

The activity of Virso Dactovin tablets are occurred by involving in some mechanism;

Virso:

Virso containing sofosbuvir has anti-hepaciviral activity, which is directly acting drug exhibits its action by prohibiting NS5B RNA reliant RNA polymerase enzyme; essential for hepatitis viral multiplication.

Sofosbuvir is metabolized to form uridine triphosphate, an essential active metabolite which exposes an anti-viral activity.

The infusion of this active metabolite into hepatitis viral RNA with the help of NS5B polymerase and causes viral chain discontinuation

Dactovin:

Dactovin containing Daclatasvir expels anti-viral activity by prohibiting NS5A protein which is needful in viral production and virion accumulation

 

Absorption

The peak plasma concentration of Dactovin tablets occurs within the range of 2 hours

The absolute bioavailability of Dactovin is 67%

The peak plasma concentration of Virso tablets occurs within the range of 0.5 to 2 hours approximately.

The food will not creates any variation in absorption of Virso Dactovin tablets, may be taken with or without food

 

Distribution

The volume of distribution in Dactovin tablet is 47L

The human plasma protein bound with Dactovin tablet is nearly 99%

The blood to plasma ratio of Virso is relatively 0.7

The human plasma protein bound with Virso occurs nearly 61 to 65%

 

Metabolism

Virso is metabolized hepatically and formed as pharmacologically active metabolite uridine triphosphate, metabolism undergone with the help of cathepsin A or carboxylesterase 1

Dactovin metabolism occurred with the help of CYP3A4

 

Elimination

88% of Daclatasvir is excreted through feces 53% as an unchanged form, 6.6% excreted through urine.

The terminal half life period of Daclatasvir is occurred at 12 to 15 hours

Sofosbuvir metabolites are excreted through 80% in urine, 14% in feces & 2.5% in exhaled air

The terminal half life period of sofosbuvir is nearly 0.51 hours

 

How to take the Tablet Virso Dactovin

Virso Dactovin tablets are administered with or without food, in the condition of hepatitis C viral infection originated by genotype I or III

Virso Dactovin is single dose regimen

 

Dosage regimens

Generally Daclatasvir is not used alone, it is combined with sofosbuvir

The recommended dosage of Virso Dactovin is one tablet should be taken as a single dose

If sofosbuvir is discontinued, Daclatasvir also get stopped

Genotype III:

Patient suffered without cirrhosis or with compensated cirrhosis:

The recommended dosage of Virso Dactovin is one tablet should be taken as a single dose with or without food (400mg/60mg)

In decompensated cirrhosis patients:

Virso Dactovin should be combined with ribavirin as a single dose (400mg/60mg)

Genotype I:

Patient suffered without cirrhosis or with compensated cirrhosis:

The recommended dosage of Virso Dactovin is one tablet should be taken as a single dose with or without food

In decompensated cirrhosis patients:

Virso Dactovin should be combined with ribavirin as a single dose

The dosage of ribavirin;

On basis of body weight & hemoglobin level of patients, dose can be calculated.

Less than 75kg: 1000mg of ribavirin; in genotype I or III 600mg of ribavirin as an initial dose and followed as 1000mg/per

At least 75 kg: in decompensated cirrhosis 1200mg of ribavirin given as twice daily

The safety and efficacy of Dactovin has not been established <18 years

Virso used in ≥12 years or weight of ≥35kg

 

Dosage adjustment due to drug interaction;

If concurrent use with strong CYP3A inhibitors, the dosage of Dactovin is reduced to 30mg while co administration

Concurrent use with moderate CYP3A inducers, the dosage of Dactovin increased to 90mg

Concomitant use of Dactovin with CYP3A strong inducers should be avoided, it is contraindicated

 

Virso Dactovin caused side effects

The most common side effects occurred during the therapy;

Cardiac problems like symptomatic bradycardia

Insomnia

Pruritus

Myalgia

Elevation of lipase

Loss of appetite

Irritability

Neutropenia

Anemia

Chills

Influenza like symptoms

Pyrexia

Pancytopenia

Asthenia

Rashes

Headache

Fatigue

Nausea

Diarrhea

 

Drug interaction

Virso Dactovin tablets concomitant with amiodarone causes serious symptomatic bradycardia

Virso Dactovin tablets concomitant with anti-convulsants, anti-mycobacterials or herbal products like st Johns wort causes decrease in effect of concentration of Virso Dactovin

While combining Virso Dactovin with strong CYP3A inducers causes loss of virological reaction rate of both products

If Virso combines with P-gp or BCRP inhibitors leads to cause elevation of sofosbuvir plasma concentration

Virso Dactovin with HMG CoA reductase inhibitors, this combination leads to cause increasing the exposure of these drugs (statins)

CYP3A strong inducers like st Johns wort, rifampin, phenytoin or carbamazepine

 

Food drug interaction

Virso Dactovin with herbal product like st. Johns wort causes decreasing the therapeutic effect of Virso Dactovin

Diet should be discussed with consultant while undergoing therapy

No food drug interaction occurs

While using Virso Dactovin tablets, caution should be taken

 

Possible contraindications

Some contraindications occurs while using Virso Dactovin tablets

In decompensated cirrhosis, combines with ribavirin contraindicated in pregnancy condition

Some anaphylactic reaction occurs if patients are contraindicated to the components present in Virso Dactovin

 

Safety measures

Using Virso Dactovin with ribavirin, should not be recommended in pregnancy condition because of producing fetal damage due to ribavirin

Virso Dactovin causes serious bradycardia while concurrent use with amiodarone, to prevent this condition some alternative medicine is given or discontinue the amiodarone if possible. Counsel the patients about the exposure of bradycardia during the treatment

While taking Virso Dactovin tablets, with CYP3A strong inducers causes loss of therapeutic response of Virso Dactovin tablets. Avoid this concomitant to reduce the adverse effects

 

Pregnancy and lactation

Virso Dactovin use in pregnancy, safe to use. The pregnancy category is B1

While combining with ribavirin, not recommended for pregnancy

Pregnancy category: X, causes fetal death

 Breast feeding should not be recommended

 

Storage and handling

The storage condition of Virso Dactovin should be stored at room temperature below 30oC (86oF) & 20oC and 25oC (68oF and 77oF) respectively

Container should be keep away from heat, light and moisture

 

Missed dose

Both Virso Dactovin tablets are single dose therapy, if patient fails to take the dose of these tablets, must consult the physician and take the dose within the time as per the instruction given by medical practitioner

Otherwise the missed dose should be skipped and follow the regular dosing schedule

 

Over dosage

The over dosage of Virso Dactovin tablets are occurred due to missed dose , if once over dosage occurs the patients must be monitored frequently for endorsement of toxicity and provide safety measures

Hemodialysis is a procedure used to eliminate the component from body, sofosbuvir removes with separation coefficient of 54% whereas Daclatasvir is problematic because nearly 99% of drug bounded to human plasma protein

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