Hepcdac

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BRAND :  HEPCDAC PRICE :  125$ STRENGTH : 60MG ACTIVE :  HEPCDAC-DACLATASVIR-60MG COMPANY NAME :  CIPLA TABLETS :  28 TABLETS read more

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Drug profile

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

Hepcdac is a single dose therapy, used in combination not alone

Hepcdac targets HBV NS5A to suppress the viral multiplication; it is applicable in the strength of 60mg

 

Brand name: Hepcdac

Active ingredients: Daclatasvir

Strength: 60MG

Mfg: Cipla

Package: 28 tablets in a container

Classification: Anti-viral agent

 

Prescribing information of Hepcdac

The main indication of Hepcdac, where it has prescribed frequently for;

Chronic hepatitis C viral infection caused by genotype III

Daclatasvir is highly effective against HCV genotype III; there is no continue side effects occur

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 Hepcdac

The mechanism of action involved in Daclatasvir is very simple, it is NS5A inhibitor, a protein which is essential for hepatitis C viral production. Hepcdac after metabolism occurs; it exhibits NS5A inhibitory activity against Hepatitis C virus and causes termination of viral production and aggregation of virion assembly


Absorption

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

The oral bioavailability of Hepcdac tablet reaches 67%

 

Distribution

Hepcdac is highly bound to the human plasma protein around 99%

The volume of distribution at steady state level occurs 47L

 

Metabolism

Hepcdac 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 Daclatasvir is relatively occurred at 12 to 15 hours

 

How to take Hepcdac tablets

Hepcdac tablets are used as single dose therapy

Hepcdac should be administered with or without food

 

Dosage regimens

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

Hepcdac should be used in HCV genotype I or III infections

Genotype I:

In adult patient without cirrhosis or with compensated cirrhosis:

The recommended dosage is 60mg of Daclatasvir with 400mg of sofosbuvir should be given as a single dose

In decompensated cirrhosis:

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

Genotype III:

In adult patient without cirrhosis or with compensated cirrhosis:

The recommended dosage is 60mg of Daclatasvir with 400mg of sofosbuvir should be given as a single dose

In decompensated cirrhosis:

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

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

 

Dosage modification:

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

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

With strong CYP3A inducers, usage of Hepcdac tablet is contraindicated

 

Hepcdac caused side effects

Headache

Fatigue

Nausea

Diarrhea

Elevation of lipase

Bradycardia

HBV reoccurrence

 

Drug interaction

Hepcdac is a CYP3A substrate, while using moderate or strong CYP3A inducers with Hepcdac tablets may causes depletion of plasma levels and therapeutic effects of Hepcdac

Hepcdac concurrent use with CYP3A strong inhibitors causes elevation of plasma level of Hepcdac

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

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

Hepcdac with amiodarone cause symptomatic bradycardia

Hepcdac with lipid lowering drugs causes increasing the effect of concentration of lipid lowering drugs

Hepcdac combined with acetyl sulfisoxazole may causes reduction in metabolism of Hepcdac  

 

Food drug interaction

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

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

 

Possible contraindications

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

Contraindicated drugs like;

Anti convulsants phenytoin, Phenobarbital, carbamazepine

Anti-mycobacterials rifampin

Herbal product st Johns wort

Anaphylactic reactions

 

Safety measures

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

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

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

There is chance of HBV reactivation in HCV/HBV co infected patients, to avoid this problem patient must examine by measuring HBV antigen, HBV core antibody before therapy

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

 

Pregnancy and lactation

Hepcdac 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

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

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

 

Missed dose

Hepcdac is a prescription medicine; if a patient fails to take the dose of Hepcdac 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

 If over dosage occurs in patients who are receiving Hepcdac 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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