Hepcfix 12 Weeks

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BRAND :  HEPCFIX PRICE :  299$ STRENGTH : 60MG ACTIVE :  HEPCFIX-DACLATASVIR-60MG-12WEEKS COMPANY NAME :  DR.REDDYS TABLETS :  28 TABLETS read more

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Drug profile

Hepcfix 12 weeks is a single dose therapy, used in combination not alone

Hepcfix 12 weeks therapy involved to targets HBV NS5A to suppress the viral multiplication; it is applicable in the strength of 60mg

Hepcfix tablets are containing Daclatasvir, an anti-viral compound useful in the treatment of chronic hepatitis C viral infection caused by genotypes III

The duration of therapy of Hepcfix - 12 weeks

 

Brand name: Hepcfix

Active ingredients: Daclatasvir

Strength: 60MG

Mfg: Dr.Reddy’s

Package: 28 tablets in a container

Classification: Anti-viral agent

 

Prescribing information of Hepcfix-12 weeks

Hepcfix 12 weeks is highly effective against HCV genotype III; there is no continue side effects occur

The main indication of Hepcfix 12 weeks , where it has prescribed frequently for;

Chronic hepatitis C viral infection caused by genotype III

One of the major disadvantage occur in Daclatasvir therapy; while combining with sofosbuvir there is a chance of reducing virological response in HCV genotype III patients

 

Mechanism of Hepcfix-12 weeks 

The mechanism of action involved in Hepcfix 12 weeks  is very simple, it is NS5A inhibitor, a protein which is essential for hepatitis C viral production.

Hepcfix 12 weeks  after metabolism occurs; it exhibits NS5A inhibitory activity against Hepatitis C virus and causes termination of viral production and virion aggregation

 

Absorption 

The absorption of Hepcfix 12 weeks tablet held rapidly, reaches peak plasma concentration within 2 hours after drug intake

The oral bioavailability of Hepcfix 12 weeks tablet reaches 67%

 

Distribution

Hepcfix 12 weeks is highly bound to the human plasma protein around 99%

The volume of distribution at steady state level occurs 47L

 

Metabolism

Hepcfix 12 weeks containing Daclatasvir is a CYP3A substrate, which is responsible for metabolism

 

Elimination

The route of elimination;

Feces: 88%

Urine: 6.6%

The terminal half life period of Hepcfix 12 weeks is relatively occurred at 12 to 15 hours

 

How to take Hepcfix-12 weeks tablets

Hepcfix tablets are used as single dose therapy

Hepcfix should be administered with or without food

 

Dosage regimens Hepcfix-12 weeks

The usual recommended dosage of Hepcfix is 60mg, should be given in combination with sofosbuvir

Hepcfix should be used in HCV genotype I or III infections

Genotype III:

In adult patient without cirrhosis or with compensated cirrhosis:

The recommended dosage is 60mg of Hepcfix with 400mg of sofosbuvir should be given as a single dose for 12 weeks

In decompensated cirrhosis:

The usual dosage is 60mg of Hepcfix with 400mg of sofosbuvir and weight based ribavirin should be taken as single dose for 12 weeks

The safety and effectiveness of Hepcfix tablet in pediatric patients has not been established with <18 years

Genotype I:

In adult patient without cirrhosis or with compensated cirrhosis:

The recommended dosage is 60mg of Hepcfix with 400mg of sofosbuvir should be given as a single dose for 12 weeks

In decompensated cirrhosis:

The usual dosage is 60mg of Hepcfix with 400mg of sofosbuvir and weight based ribavirin should be taken as single dose for 12 weeks

Dosage modification:

Hepcfix with strong CYP3A inhibitors used, the dosage of Hepcfix should be reduced into 30mg

With moderate CYP3A, the dosage of Hepcfix should be 90mg as a single dose

With strong CYP3A inducers, usage of Hepcfix tablet is contraindicated

 

Hepcfix 12 weeks caused side effects

Diarrhea

Elevation of lipase

Bradycardia

Headache

Fatigue

Nausea

HBV reactivation

 

Drug interaction-Hepcfix 12 weeks

Hepcfix 12 weeks therapy, with amiodarone cause symptomatic bradycardia

Hepcfix 12 weeks therapy, with lipid lowering drugs causes increasing the effect of concentration of lipid lowering drugs

Hepcfix is a CYP3A substrate, while using moderate or strong CYP3A inducers with Hepcfix tablets may causes depletion of plasma levels and therapeutic effects of Hepcfix 12 weeks therapy.

Hepcfix 12 weeks therapy, concurrent use with CYP3A strong inhibitors causes elevation of plasma level of Hepcfix

Hepcfix is a P-gp, BCRP, organic anion transporting polypeptide inhibitors, whereas co administration of these drugs with Hepcfix causes increasing the systemic exposure of these drugs, which could elevate the adverse effects

Hepcfix 12 weeks therapy, combined with acetyl sulfisoxazole may causes reduction in metabolism of Hepcfix

Strong CYP3A inhibitors: clarithromycin, itraconazole, posaconazole, voriconazole, ketaconazole, atazanavir/ritonavir

Moderate CYP3A inhibitors: ciprofloxacin, atazanavir, erythromycin, verapamil, diltiazem, fluconazole

Moderate CYP3A inducers: dexamethasone, rifapentine, modafinil, efavirenz, Bosentan

 

Food drug interaction-Hepcfix 12 weeks

No food drug interaction occur, consult with physician about diet while using Hepcfix tablet

Whereas herbal product likes st. Johns wort with Hepcfix tablets causes loss of therapeutic effect of Hepcfix

 

Possible contraindications-Hepcfix 12 weeks

Hepcfix concurrent use with CYP3A strong inducers, leads to depletion of virological response of Hepcfix

Contraindicated drugs like;

Anti convulsants phenytoin, Phenobarbital, carbamazepine

Anti-mycobacterials rifampin

Herbal product st Johns wort

Anaphylactic reactions

 

Safety measures-Hepcfix 12 weeks

While using with amiodarone, causes serious bradycardia it is controlled by providing counsel to the suspected patients, or prescribe alternative medicines

Care should be taken while using in renal and hepatic impairment patients, because of no dosage adjustment preferred

Some adverse reactions occurred due to drug interaction, it may include as;

  • Severe adverse effects occurred due to concomitant drugs
  • Lack of therapeutic effect of Hepcfix and cause advancement of resistance

HBV reactivation in HCV/HBV co-infected patients, care should be taken before starting the therapy

The safety and effectiveness of Hepcfix in liver transplanted patients has not been established.

 

Pregnancy and lactation-Hepcfix 12 weeks

Hepcfix is combined with ribavirin causes fetal damage, it should not be recommended

Ribavirin pregnancy category: X

Breast feeding should not be recommended while combining with ribavirin.

 

Storage and handling-Hepcfix 12 weeks

The storage condition of Hepcfix tablet container should be stored at 20oC and 25oC

Container should be keep away from heat, moisture, and light

 

Missed dose-Hepcfix 12 weeks

Hepcfix is a prescription medicine; if a patient fails to take the dose of Hepcfix must consult with medical practitioner and take the dose as soon as possible. Otherwise the missed dose should be skipped and follow the regular dosing schedule

 

Over dosage-Hepcfix 12 weeks

 If over dosage occurs in patients who are receiving Hepcfix tablet, vital symptoms should be monitored frequently and provide supportive measures. Daclatasvir is difficult to eradicate from the body because it is highly bound to human plasma protein

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