Dactovin 12 Weeks

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BRAND :  DACTOVIN PRICE : 299 $ STRENGTH : 60MG ACTIVE INGERIDENTS:  DACTOVIN-DACLAHEP-60MG COMPANY NAME :  STRIDES TABLETS COUNT :  28 TABLETS read more

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Drug profile

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

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

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


Brand name: Dactovin

Active ingredients: Daclatasvir

Strength: 60MG

Mfg: Strides

Package: 28 tablets in a container

Classification: Anti-viral agent


Prescribing information of Dactovin

The main indication of Dactovin, 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 Dactovin

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

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

The oral bioavailability of Dactovin tablet reaches 67%


Distribution

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

The volume of distribution at steady state level occurs 47L


Metabolism

Dactovin 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 Dactovin is relatively occurred at 12 to 15 hours


How to take Dactovin tablets

Dactovin tablets are used as single dose therapy

Dactovin should be administered with or without food


Dosage regimens

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

Dactovin 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 Dactovin with 400mg of sofosbuvir should be given as a single dose

In decompensated cirrhosis:

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

In decompensated cirrhosis:

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

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


Dosage modification:

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

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

With strong CYP3A inducers, usage of Dactovin tablet is contraindicated


Dactovin caused side effects

Headache

Fatigue

Nausea

Diarrhea

Elevation of lipase

HBV reaction in HCV/HBV co infected patients

Bradycardia


Drug interaction

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

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

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

Dactovin with amiodarone cause symptomatic bradycardia

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

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

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

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

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


Possible contraindications

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

Contraindicated drugs like;

Anti-mycobacterials rifampin

Herbal product st Johns wort

Anti convulsants phenytoin, Phenobarbital, carbamazepine

Anaphylactic reactions


Safety measures

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

HBV reactivated in HCV/HBV co infected patients, to prevent this problem which is occurred during post-therapy by investigating the patient with antigen & antibody of HBVvalues before therapy

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;

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

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


Pregnancy and lactation

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

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


Missed dose

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