Resof-Hepcfix

A Resof-Hepcfix tablet consist of two most conspicuous active substances which will exhibits anti-viral activity against hepatitis C viral infection. Two components like; Sofosbuvir; Daclatasvir Resof-Hepcfix tablet which is approved by FDA and it is first established product comes under the combination of sofosbuvir and Daclatasvir. Usually Daclatasvir is not used as monotherapy; it must be concomitant with sofosbuvir for potent anti-viral activity. Resof-Hepcfix is a single dose therapy, with minimal adverse effects. Resof-Hepcfix has better effectiveness in chronic hepatitis condition.

Sofosbuvir-Daclatasvir

Resof-Hepcfix

400mg & 60mg

Dr. Reddy’s




Resof-Hepcfix indicated for

The primary indications of Resof-Hepcfix tablets are; Involved in advance or long-lasting hepatitis C viral infection mainly associated to genotype I or III.

The only drawback occurred in Resof-Hepcfix tablet taking patients;

There is a chance of reduction in virologic response rate in patients who are all receiving Resof-Hepcfix for 12 weeks in HCV genotype III conditions. The usage of Resof-Hepcfix is only occurred in adolescents; not in pediatric patients. The potency of Resof-Hepcfix tablet has not been evaluated in pediatric patients.

Resof-Hepcfix exhibits anti-viral activity by (mechanism)

Resof-Hepcfix in addition to tablet has two segments Sofosbuvir and Daclatasvir

Sofosbuvir:
Sofosbuvir is a prohibitor of nucleotide simple, particularly precludes HCV non-auxiliary protein 5B RNA subordinate RNA polymerase. Sofosbuvir experience intracellular digestion, which deliver pharmacologically dynamic compound like uridine simple triphosphate. Sofosbuvir mediated into RNA of hepatitis C infection with the assistance of NS5B polymerase. This may goabout as chain eliminator.

Daclatasvir:
Non-basic 5A protein is fundamental for viral duplication. Daclatasvir meddle with the action of NS5A protein, this may prompt viral annihilation.



Maximum plasma concentration time of; Sofosbuvir 0.5 to 2 hours Daclatasvir 2 hours No effect of food, may take with or without food

Bioavailability of Daclatasvir 67% The human plasma protein bounds to; Sofosbuvir: 61 to 65% Daclatasvir: 99%

Sofosbuvir is metabolized by liver, using carboxyl esterase 1 or cathepsin A as a catalyst During metabolism sofosbuvir is converted into active uridine triphosphate Daclatasvir is a substrate of CYP3A.

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Resof+Hepcfix
Brand Resof-Hepcfix
Ingredients Sofosbuvir-Daclatasvir
Strength 400mg & 60mg
Manufactured Dr. Reddy’s
Rating

Before starting the therapy with Resof-Hepcfix tablets, patient undergone hepatic function test and examine the lab measurements. If patient suspected with HBV infection, must be investigate by counting the hepatitis B surface antigen & hepatitis B core antibody. Resof-Hepcfix tablet is containing 60mg of Daclatasvir & 400mg of sofosbuvir. The usual dosage of Resof-Hepcfix is one tablet to be given orally as once a day. Resof-Hepcfix tablet should be administered with or without food.

Patients with HCV genotype I infection:

Without cirrhosis or child Pugh A or B (compensated cirrhosis): The usual dose of Resof-Hepcfix is one tablet should be given orally as once a day. Decompensated cirrhosis (child Pugh C): The usual recommended dosage is one tablet of Resof-Hepcfix should be administered orally as once daily by combining with ribavirin.

Patients with HCV genotype III infection:

Without cirrhosis or child Pugh A or B (compensated cirrhosis): The recommended dose of Resof-Hepcfix is one tablet should be given orally as once a day. In compensated, decompensated cirrhosis or post liver transplantation: The recommended dosage of Resof-Hepcfix tablet is one tablet to be administered orally as a single dose.

Dosage recommendation of Ribavirin:

Patient with HCV related genotype I or III: The recommended dose of ribavirin is 600mg should be taken as an initial dose, followed by increasing up to 1000mg. Patient with compensated cirrhosis: The dosage of ribavirin should be based on the body weight of the patients. Based on the weight of the HCV suspected patients; At least 75kg: 1200mg of ribavirin should be taken Below 75kg: 1000mg should be taken Ribavirin should be administered with or without food.

Over dosage

There are no known antitoxins forResof-Hepcfix overdose. Therapy of overdose with Resof-Hepcfix should consist of general supportive measures, containchecking of vital signs and observation of the patient’s clinical status.

Resof-Hepcfix causing side effects

Pruritus, Asthenia, Anemia, Loss of appetite, Flu like syndrome, Pyrexia, Diarrhea, Fatigue, Headache, Insomnia, Nausea, Rash, Neutropenia, Myalgia, Irritability, Pancytopenia, Rising level of bilirubin, creatine kinase, lipase, AST & ALT HBV reoccurrence may occur Serious bradycardia while combining with amiodarone

Resof-Hepcfix safety precautions

Use cautiously in the patients who are suspected with HBV infection, there is a chance of elevating the exposure of HBV reoccurrence in the patient co infected with HCV & HBV Serious bradycardia occurs while concurrent use of Resof-Hepcfix tablet with amiodarone.

Increasing risk of loss of therapeutic effect occurs while concurrently use Resof-Hepcfix tablet with P-gp inducers or inhibitors Severe adverse may occur due to drug interaction, to prevent this problem avoid this type of combinational therapy.

Resof-Hepcfix warning signs

Hepatitis B viral infection reactivation occurs in patient co infected with HCV & HBV; to avoid this problem patients must be undergone liver function test. This may occur due to fail to take HBV anti-viral agents.

The major demerit of Resof-Hepcfix tablet is loss of virological response rate in patients with HCV infection related to genotype I or III with the duration of therapy for 12 weeks. Serious life-threatening condition like bradycardia occurs while using Resof-Hepcfix with amiodarone.

Resof-Hepcfix drug interactions

  • Resof-Hepcfix tablet combined with protease inhibitors causes elevating the effect of concentration of Daclatasvir
  • Resof-Hepcfix tablets are concurrently used with non-nucleoside reverse transcriptase inhibitor causes reducing the effect of concentration of Daclatasvir
  • Resof-Hepcfix tablet combined with amiodarone causes severe bradycardia.
  • Resof-Hepcfix tablets are concomitantly used with lipid lowering drugs causes increasing concentration of these drugs.
  • Resof-Hepcfix tablet combined with anti-convulsants, anti-mycobacterials 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 combining Resof-Hepcfix tablet with P-gp inducers causes decreasing the plasma concentration of sofosbuvir. This may results as loss of therapeutic effect.
  • Daclatasvir is a CYP3A substrate, while taking Resof-Hepcfix tablet with CYP3A strong inducers may causes loss of therapeutic effect of Daclatasvir.
  • Resof-Hepcfix combined with drugs inhibits the CYP3A may elevates the plasma level of Daclatasvir
  • Alteration in INR or prothrombin time may occur in patient receiving warfarin with Resof-Hepcfix tablets.
  • Resof-Hepcfix tablet combine with P-gp or BCRP inhibitors, may leads to cause prolonging the adverse effects of these substrates.


Contraindications


No contraindication occurs, while concurrently used with ribavirin are contraindicated to pregnancy. Some anaphylactic reactions may occur due to the patients are contraindicated to the components present in the Resof-Hepcfix tablet.

Lactation


Breast feeding should not be recommended.



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Resof-Hepcfix usage in

Resof-Hepcfix is safe to use in pregnancy condition. Resof-Hepcfix is combined with ribavirin causes some fetal damage. Avoid this concomitant during pregnancy

Resof-Hepcfix tablet container should be kept at temperature below 30°C The Resof-Hepcfix tablet container should be free from moisture, heat & light.

If dose is missed, then have the dose immediately before the time of next dose or skip the missed dose and continue the normal schedule. Avoid having two doses at one time. Please consult to doctor for further information.




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