Hepcinat Plus

Brand name:  Hepcinat plus Active components:  Sofosbuvir & Daclatasvir Strength:  400mg & 60mg respectively Mfg:  Natco pharma Package:  28 tablets... read more

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Hepcinat plus tablet drug profile;

Hepcinat plus tablet is manufactured by Natco pharma which is first FDA approved product comes under the combination of two eminent anti-viral compounds like Sofosbuvir & Daclatasvir.

Hepcinat plus tablet is most effective and produces less number of side effects.

Sofosbuvir is a present as a prodrug and exhibits its action by converting into active moiety. Daclatasvir is not used as single, must be used in combination with other anti-viral agent called sofosbuvir and expels prominent effect against hepatitis virus.

Brand name: Hepcinat plus

Active components: Sofosbuvir & Daclatasvir

Strength: 400mg & 60mg respectively

Mfg: Natco pharma

Package: 28 tablets in a container

Classified as: Anti-hepaciviral drug

Prescribing information of Hepcinat plus tablet;

The most common usage of Hepcinat plus tablet is produced anti-viral activity against chronic hepatitis C viral infection caused by genotype I or III.

The major drawback of this combination therapy is given as follows;

The patient suspected with hepatitis C viral infection associated genotype III may lose their virological response due to the combination of sofosbuvir with Daclatasvir.

Mechanism;

Hepcinat plus  tablets have two fragments Sofosbuvir and Daclatasvir

Sofosbuvir:

Sofosbuvir is a prohibitor of nucleotide basic, especially blocks HCV non-helper protein 5B RNA subordinate RNA polymerase.

Sofosbuvir encounter intracellular absorption, which conveys pharmacologically powerful compound like uridine basic triphosphate.

Sofosbuvir intervened into RNA of hepatitis C contamination with the help of NS5B polymerase.

This may go about as chain eliminator.

Daclatasvir:

Non-essential 5A protein is the key for viral duplication.

Daclatasvir interfere with the activity of NS5A protein, this may prompt viral destruction.

Absorption

Peak plasma concentration of  Hepcinat Plus ;

Sofosbuvir: 0.5 to 2 hours

Daclatasvir: within 2 hours

Food should not be considered majorly, it should be administered with or without food.

Oral bioavailability occurred in Daclatasvir is 67%

Distribution od Hepcinat Plus 

Plasma protein binding capacity;

Sofosbuvir 61 to 65%

Daclatasvir nearly 99%

Sofosbuvir metabolite has the minimal binding effect

Metabolism of Hepcinat Plus 

Metabolism of sofosbuvir is involved in the liver, with the help of carboxyl esterase 1 or cathepsin A

Nearly 99% of Daclatasvir is binding to protein and it is the substrate of CYP3A.

Elimination of Hepcinat Plus 

Elimination occurs in urine, faeces, exhaled air

Sofosbuvir: 80% through urine, 14% through faeces & 2.5% through exhaled air

Daclatasvir: 88% in feces; 6.6% in urine

The terminal half-life period of Hepcinat plus;

Sofosbuvir: 0.4 hours; GS-331007 27 hours

Daclatasvir: 12 to 15 hours

When to take Hepcinat plus;

Hepcinat Plus  tablet should be administered with or without food. It is considered  a single dose regimen

Hepcinat plus dosing regimen;

Hepcinat plus: Sofosbuvir 400mg & Daclatasvir 60mg

The usual dose of Hepcinat plus tablet is one tablet should be taken as a single dose by administering with food or without food.

In severe condition, Hepcinat plus must be combined with ribavirin.

In HCV genotype I or III patients with decompensated cirrhosis or post-transplantation; the initial dose of ribavirin is 600mg as a single dose, elevating dose up to 1000mg.

In compensated cirrhosis; the initial dose of ribavirin should be calculated on the basis of body weight of the suspected patients.

In patient with the weight of at least 75kg: 1200mg of ribavirin should be considered.

In patient with the weight of less than 75kg: 1000mg of ribavirin should be used.

In genotype I:

The patient suffered without cirrhosis & compensated cirrhosis: The dose of Hepcinat plus is one tablet should be taken with or without food as a single dose.

In decompensated cirrhosis or post-liver transplantation: The recommended dose of Hepcinat plus is one tablet to be taken as a single dose by combining with ribavirin on weight basis manner.

In genotype III:

Patient struggling without cirrhosis: The usual dose of Hepcinat plus is one tablet to be taken as a single dose.

Patient with compensated, decompensated cirrhosis or post-liver transplantation:

The usual dose is one Hepcinat plus tablet should be combined with ribavirin as a single dose.

While receiving ribavirin, the patient must be administered food.

Ribavirin should be taken as twice daily.

 

Hepcinat plus tablet caused side effects;

Neutropenia

Myalgia

Irritability

Pancytopenia

Elevation of bilirubin, creatine kinase, lipase, AST & ALT

HBV reoccurrence may occur

Serious bradycardia while combining with amiodarone

Fatigue

A headache

Insomnia

Nausea

Pruritus

Asthenia

Anaemia

Loss of appetite

Flu-like syndrome

Pyrexia

Diarrhoea

Rash

Drug-drug interaction;

Hepcinat plus consisting of two most effective component like sofosbuvir & Daclatasvir;

Daclatasvir is a CYP3A substrate, while taking Hepcinat plus tablet with CYP3A strong inducers may lead to reducing the therapeutic effect of Daclatasvir.

Hepcinat plus combined with drugs inhibit the CYP3A may elevate the plasma level of Daclatasvir

Alteration in INR or prothrombin time may occur in the patient receiving warfarin with Hepcinat plus tablets.

Hepcinat plus tablet combine with P-gp or BCRP inhibitors, may lead to cause prolonging the adverse effects of these substrates.

Hepcinat plus tablet concurrently used with protease inhibitors causes increasing the effect of concentration of Daclatasvir

Hepcinat plus tablets are concomitantly used with non-nucleoside reverse transcriptase inhibitor causes diminishing the effect of concentration of Daclatasvir

Hepcinat plus tablet co-administered with amiodarone causes severe bradycardia.

Hepcinat plus tablets are concurrently used with lipid-lowering drugs causes an increasing concentration of these drugs.

Hepcinat plus tablet concurrently used with anticonvulsants, anti-mycobacterial or herbal products like st. Johns wort causes decreasing the effect of concentration of sofosbuvir. 

Sofosbuvir is a P-gp or BCRP drug transporter substrate, while concomitating Hepcinat plus tablet with P-gp inducers causes reducing the plasma concentration of sofosbuvir. This may result in the loss of therapeutic effect.

Food-drug interaction:

There is no possible food-drug interaction occurs during the therapy.

Diet should be maintained after getting advice from the physician

While concomitant with ribavirin, should not be taken on an empty stomach.

Possible Contraindications with Hepcinat plus

While Hepcinat plus tablet combined with ribavirin which is contraindicated to pregnant women.

Anaphylactic reactions may occur because the patients may be contraindicated to the component present in the Hepcinat plus tablet.

Safety measures;

Hepcinat plus tablet warning;

The major demerit of Hepcinat plus tablet is;

  1. Reoccurrence of HBV infections in the patients who are co-infected with both HCV & HIV

This adverse condition may be reduced by;

Examine the patients who are going to receive the Hepcinat plus tablet formerly with HBV infection present or not.

This may occur in the patients who are not taking anti-hepatitis B viral drugs.

To avoid this condition, patients must be investigated by undergone liver function test.

  1. Serious bradycardia may occur

This may occur due to concomitant use of Hepcinat plus with amiodarone, cause increase the effect of concentration of amiodarone leads to increase the risk associated to amiodarone.

A safety precaution takes place in Hepcinat plus tablet treatment;

HBV reactivation:

In HCV/HIV co-infected patients who have completed the directly acting anti-viral therapy and not receiving anti-hepatitis B viral therapies; HBV reappearance has been expressed.

This condition causes liver injury may lead to death. To overcome this problem by measuring the HBsAg & anti-HBc counts and also take a liver function test by monitoring the bilirubin, AST & ALT levels.

Bradycardia:

Severe life-threatening bradycardia occurs during the combinational therapy of Hepcinat plus tablet with amiodarone.

To overcome this condition;

The patient should be counsel prior to starting the treatment.

Cardiac monitoring should take place periodically

Provide a substitute for reducing the adverse effects

Avoid concomitant use of Hepcinat plus tablet with P-gp inducers, to prevent the loss of therapeutic effect. Concurrent uses of Hepcinat plus with rifampin or st. Johns wort is not suggested.

Risk related to combinational therapies; while concomitating the Hepcinat plus with other medical care should be taken to avoid the interaction related adverse effects.

Pregnancy & Lactation

Hepcinat plus is safe to use in pregnancy period

Concomitant use of Hepcinat plus with ribavirin should not be recommended in pregnancy

Ribavirin pregnancy category: X; causes fetal damage

Hepcinat plus pregnancy category

Sofosbuvir: B

Daclatasvir: C

Breast feeding should not be allowed

Storage & handling:

Hepcinat plus container should be stored at below 30oC

Keep the container free from moisture, heat & light

Missed dose;

Hepcinat plus is a single dose therapy, if a patient does not take the dose of Hepcinat plus tablet must consult with the physician and follow the advice.

Otherwise, the missed dose should be avoided and continue the regular schedule.

Over dosage;

The maximum dose of sofosbuvir is 1200mg, in case of overdosage condition;

Patients may provide with supportive measures

Alternative medicines should be recommended

Sofosbuvir overload is eliminated from the body by undergoing hemodialysis; 4 hours of a process should remove nearly 18% of sofosbuvir content from the body

Daclatasvir is difficult to remove because it is highly bound to human plasma protein, but provide supportive measures to reduce the signs and symptoms.

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