Dacihep

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BRAND :  DACIHEP PRICE :  125$ STRENGTH : 60MG ACTIVE INGERIDENTS:  DACIHEP-DACLATASVIR-60MG COMPANY NAME :  ZYDUS HEPTIZA TABLETS COUNT :  28 TABLETS read more

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DESCRIPTION :

Drug profile

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

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

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

 

Brand name: Dacihep

Active ingredients: Daclatasvir

Strength: 60MG

Mfg: Zydus hepatica

Package: 28 tablets in a container

Classification: Anti-viral agent

 

Prescribing information of Dacihep

Dacihep 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

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

Chronic hepatitis C viral infection caused by genotype III

 

Mechanism of Dacihep

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

Dacihep 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 Dacihep tablet held rapidly, reaches peak plasma concentration within 2 hours after drug intake

The oral bioavailability of Dacihep tablet reaches 67%

 

Distribution

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

The volume of distribution at steady state level occurs 47L

 

Metabolism

Dacihep 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 Dacihep is relatively occurred at 12 to 15 hours

 

How to take Dacihep tablets

Dacihep tablets are used as single dose therapy

Dacihep should be administered with or without food

 

Dosage regimens

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

Dacihep should be used in HCV genotype I or III infections

Genotype III:

In decompensated cirrhosis:

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

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

In adult patient without cirrhosis or with compensated cirrhosis:

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

Genotype I:

In adult patient without cirrhosis or with compensated cirrhosis:

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

In decompensated cirrhosis:

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

Dosage modification:

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

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

With strong CYP3A inducers, usage of Dacihep tablet is contraindicated

 

Dacihep caused side effects

Diarrhea

Elevation of lipase

Fatigue

Nausea

Bradycardia

HBV reactivation

Headache

 

Drug interaction

Dacihep with amiodarone cause symptomatic bradycardia

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

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

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

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

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

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

 

Food drug interaction

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

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

 

Possible contraindications

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

Contraindicated drugs like;

Anti-mycobacterials rifampin

Herbal product st Johns wort

Anti convulsants phenytoin, Phenobarbital, carbamazepine

Anaphylactic reactions

 

Safety measures

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 Dacihep and cause advancement of resistance

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

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

Safe in use while using Dacihep in HCV/HBV co infected patients; there is a risk of HBV reactivation occurs

 

Pregnancy and lactation

Dacihep 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 Dacihep tablet container should be stored at 20oC and 25oC

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

 

Missed dose

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