Resof Total 12 Weeks

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BRAND :  RESOF TOTAL PRICE :  899 STRENGTH :  400MG + 100MG ACTIVE :  RESOF-TOTAL-12-WEEKS-DRREDDYS-SOFOSBUVIR-400MG-VELPATASVIR-100MG COMPANY NAME :  DR. REDDY'S... read more

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Drug profile

Resof Total tablet containing 400mg of sofosbuvir and 100mg of Velpatasvir. Resof Total tablets are used as single dose for 12 weeks

Resof Total is an oral used tablet, for severe chronic hepatitis C viral infection.

Resof Total contains fixed dose combination medicine like sofosbuvir and Velpatasvir.


Prescribing information of Resof Total for 12 weeks

The prescribing advice of Resof Total for the patients;

Resof Total is involved in the conditions such as;

In the treatment of chronic hepatitis C viral infection associated with genotype I, II, III, IV, V or VI. It may used in two conditions like;

  1. Patients without cirrhosis or with compensated cirrhosis (child Pugh A)
  2. Patients with decompensated cirrhosis (child Pugh B or C), concurrently used with ribavirin

Trade name: Resof Total

Active components: Sofosbuvir & Velpatasvir

Strength of the components: 400mg & 100mg

Mfg: Dr.Reddy’s

Package: 28 tablets in a container

Category: Anti-hepaciviral drugs


Mechanism of Resof Total for 12 weeks

Resof Total has sofosbuvir & Velpatasvir, in which sofosbuvir is consider as nucleotide associated with HCV NS5B polymerase prohibitor, whereas Velpatasvir is consider as NS5A prohibitor

Mechanism involved in this two components are includes as;

Sofosbuvir:

Sofosbuvir is a directly acting anti-viral drug, NS5B RNA dependent RNA polymerase. This enzyme is required for hepatitis viral replication; sofosbuvir is a prodrug which endures into intracellular metabolism to form pharmacologically active metabolite known as uridine triphosphate GS-461203.

This metabolite is inserted into hepatitis C viral RNA by NS5B polymerase and acts as chain terminator.

Velpatasvir is a NS5A prohibitor, a protein responsible for viral production


Absorption

The effect of food with Resof Total is determined as;

With moderate meal compared to fasted state: sofosbuvir increased to 60% & Velpatasvir increased to 34%

With high fat meal: sofosbuvir increased to 78% & Velpatasvir increased to 21%

The peak plasma time of sofosbuvir reaches within 0.5 to 1 hour and Velpatasvir occurs within 3 hours


Distribution

In Resof Total, human plasma protein bounding capacity with sofosbuvir occurs at 61 to 65% & Velpatasvir >99.5%

The blood plasma ratio of sofosbuvir is 0.7 & Velpatasvir is 0.52 to 0.67


Metabolism

Resof Total is metabolized highly in liver. The metabolism of sofosbuvir occurs with the help of cathepsin A, CES1, HINT1 & Velpatasvir is metabolized by various cytochrome isoenzymes like CYP2B6, CYP2C8 & CYP3A4


Excretion

The major route of elimination of;

Sofosbuvir is occurred through 8% in urine and 14% in feces; Velpatasvir 0.4% in urine & 94% in feces as an unchanged form

The terminal half life period of Resof Total tablet;

Sofosbuvir: 0.51 hours

Velpatasvir: 15 hours


When to take the Resof Total tablet 12 weeks

Resof Total tablet is used as a single dose; it should be taken with or without food

Resof Total is continued for 12 weeks for improved healing


Dosage regimens of Resof Total for 12 weeks

Before starting the therapy, patient must examine by measuring hepatitis B antigen & hepatitis B core antibody, to avoid the reaction of HBV infection

The recommended dosage of Resof Total is one tablet should be taken as a single dose for 12 weeks

The recommended dosage regimen in HCV associated with genotype I, II, III, IV, V or VI

In new patients & already treated patients without cirrhosis and with compensated cirrhosis:

The recommended dosage is one tablet of Resof Total followed for 12 weeks with or without food

In new or already treated patients with child Pugh B or C (decompensated cirrhosis):

The recommended dosage of Resof Total tablet is one tablet should be combined with ribavirin and followed for 12 weeks

Dosage adjustment should not be followed in both renal and hepatic impaired patients

The dosage of ribavirin is recommended on the basis of body weight of the patients;

Less than 75kg: 1000mg per day

At least 75kg: 1200mg per day

In pediatric patients, safety and efficacy has not been established


Resof Total caused side effects

Resof Total tablets are taken for the period of 12 weeks, in this condition some adverse effects occurs includes as;

Headache

Reactivation of HBV infection occurred in HBV/HIV-1 co infected patients

Bradycardia occurs severely in case of concomitant with amiodarone

Asymptomatic creatine kinase elevation

Fatigue

Insomnia

Asthenia

Increasing bilirubin level occurred in 12 weeks therapy

After therapy, cardiac disorders occurs

Skin rashes, sometimes angioedema like inflammated angioedema

Anemia

Diarrhea

Elevation of lipase level


Drug interaction

Resof Total tablets concurrently used with herbal products like st. Johns wort causes depleting the effect of concentration of Resof Total

Resof Total not co administered with acid reducing drugs, because it may cause decreasing the effect of concentration of Velpatasvir

Amiodarone combined with Resof Total tablets, causes serious bradycardia

Digoxin with Resof Total causes increasing the exposure of digoxin

Resof Total tablet with anti-convulsants like carbamazepine, phenytoin or Phenobarbital causes decreasing the exposure of Resof Total

If Resof Total concomitant with HMG CoA reductase inhibitors causes increasing the exposure of these drugs

Resof Total is a substrate of P-gp & BCRP transporters, Resof Total concurrently used with P-gp inducers or potent inducers of CYP2B6 or CYP3A4 (rifampin, st. Johns wort) causes decreasing in plasma concentration of Resof Total and thus leads to decrease the therapeutic effect of Resof Total

Velpatasvir is an P-gp & BCRP drug transporter inhibitor, whereas concomitant use of Resof Total with these drugs may have chance to cause increasing the exposure of these drugs

If Resof Total tablet combined with anti-cancer drug this may cause increasing the effect of concentration of these drugs


Food drug interaction

Food does not interact with Resof Total tablets, but herbal product like st. Johns wort combined with Resof Total causes decreasing the therapeutic effect of Resof Total


Possible contraindications of Resof Total for 12 weeks

In chronic condition, Resof Total combined with ribavirin followed for 12 weeks, in such condition ribavirin is contraindicated to pregnancy condition

Resof Total tablets causes hypersensitivity reactions in some patients who are contraindicated to the component present in Resof Total tablet


Safety measures

Serious symptomatic bradycardia occurs while combining with amiodarone, to avoid this problem patient must counsel about the risk of bradycardia, or substitute viable therapy has been taken

There is a chance of reduction of therapeutic effect of Resof Total while combining with P-gp inducers

Serious fetal abnormality occurs while concomitant use with ribavirin

During or after the therapy, some adverse effects may occurs


Pregnancy and lactation in Resof Total 12 weeks

Resof Total tablet used alone for acute condition, pregnancy condition is B1; safe to use

Whereas in decompensated cirrhosis, pregnancy condition is categorized as X due to combination with ribavirin. Ribavirin is contraindicated in pregnancy condition


Storage and handling

Resof Total tablet container should be stored at room temperature below 30oC (86oF)

Container should be keep away from heat, light and moisture


Missed dose

Resof Total is a prescription medicine; it should not be used without valid prescription

If patient fail to take the dose of Resof Total tablet, must consult with physician and take the dose as soon as possible

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


Over dosage

The over dosage of Resof Total for 12 weeks should not have definite antidote, if it occurs the patients must be investigate with the occurrence of toxicity.

The clinical status of the patients who are affected with over dose should be periodically monitored

The another method of treating the over dosage of Resof Total is hemodialysis, to expels the excess amount of components present in Resof Total with an eradication co efficient of 53%; whereas Velpatasvir is highly bound to human plasma protein and it is difficult to remove

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