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Drug profile

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

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

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


Brand name: Natdac

Active ingredients: Daclatasvir

Strength: 60MG

Mfg: Natco

Package: 28 tablets in a container

Classification: Anti-viral agent


Prescribing information of Natdac

The main indication of Natdac, 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 reduci

ng virological response in HCV genotype III patients


Mechanism of Natdac

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



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

The oral bioavailability of Natdac tablet reaches 67%



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

The volume of distribution at steady state level occurs 47L



Natdac containing Daclatasvir is a CYP3A substrate, which is responsible for metabolism



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 Natdac tablets

Natdac tablets are used as single dose therapy

Natdac should be administered with or without food


Dosage regimens

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

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

In decompensated cirrhosis:

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

In decompensated cirrhosis:

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

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


Dosage modification:

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

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

With strong CYP3A inducers, usage of Natdac tablet is contraindicated


Natdac caused side effects




HBV reactivation


Elevation of lipase



Drug interaction

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

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

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

Natdac with amiodarone cause symptomatic bradycardia

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

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

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 Natdac tablet

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


Possible contraindications

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

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

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;

ü  Lack of therapeutic effect of Natdac and cause advancement of resistance

ü  Severe adverse effects occurred due to concomitant drugs

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

HBV reoccurred in the patients who are all having HCV/HBV co infection after the treatment has been concluded


Pregnancy and lactation

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

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


Missed dose

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