Dakovir-C 60 Tablet
Daclatasvir
60mg
Beximco Pharmaceuticals Ltd.
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| Retail Price | 400.00 AED |
Indications
Dakovir-C 60 Tablet is used for:
Chronic hepatitis C virus infection
Adult Dose
Oral
Hepatitis C
Indicated for use with sofosbuvir, with or without ribavirin, for the treatment of chronic HCV genotype 1 or 3 infection
Genotype 1
Without cirrhosis or with compensated (Child-Pugh A) cirrhosis: 60 mg (plus sofosbuvir 400 mg) once daily for 12 weeks
Decompensated (Child-Pugh B or C) cirrhosis or posttransplant: 60 mg (plus sofosbuvir 400 mg) once daily plus ribavirin for 12 weeks
Genotype 3
Without cirrhosis: 60 mg (plus sofosbuvir 400 mg) once daily for 12 weeks
Compensated (Child-Pugh A) or decompensated (Child-Pugh B or C) cirrhosis, or posttransplant: 60 mg (plus sofosbuvir 400 mg) once daily plus ribavirin for 12 weeks
Child Dose
Renal Dose
Renal impairment (any degree): No dose adjustment required
Administration
May be taken with or without food.
Contra Indications
Hypersensitivity. Co-administration w/ strong CYP3A4 inducers & P-gp eg phenytoin, carbamazepine, oxcarbazepine, phenobarb, rifampicin, rifabutin, rifapentine, systemic dexamethasone, St. John's wort.
Precautions
Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment.
Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
Bradycardia When Coadministered with Sofosbuvir and Amiodarone:
Serious symptomatic bradycardia may occur in patients taking amiodarone with sofosbuvir in combination with another HCV direct-acting agent, including Daclatasvir, particularly in patients also receiving beta blockers or those with underlying cardiac comorbidities and/or advanced liver disease.
Coadministration of amiodarone with Daclatasvir in combination with sofosbuvir is not recommended. In patients with no alternative treatment options, cardiac monitoring is recommended.
Pregnancy-Lactation
Pregnancy
No data in pregnant women are available
If daclatasvir and sofosbuvir are administered with ribavirin, the warnings and precautions for ribavirin, in particular the pregnancy avoidance warning, apply to this combination regimen
Lactation
Unknown if distributed in human breast milk
The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Interactions
May lead to lower exposure & loss of efficacy w/ phenytoin, carbamazepine, oxcarbazepine, phenobarb, rifampicin, rifabutin, rifapentine, systemic dexamethasone & St. John's wort. Decreased plasma levels & therapeutic effect w/ strong or moderate CYP3A4 & P-gp inducers.
Increased plasma levels w/ strong CYP3A4 inhibitors.
May increase systemic exposure of P-gp, OATP, 1B1, OCT1 or BCRP substrates.
Boceprevir, telaprevir, atazanavir/ritonavir, efavirenz, cobicistat-containing, clarithromycin, telithromycin, erythromycin, dabigatran, etexilate, posaconazole, voriconazole, amiodarone, digoxin, Ca channel blockers, HMG-CoA reductase inhibitors.
Adverse Effects
Side effects of Daclatasvir :
>10%
Headache (14%),Fatigue (14%)
1-10%
Nausea (8%),Diarrhea (5%),Elevated lipase, >3 x ULN (2%)
Mechanism of Action
Inhibits NS5A, a nonstructural protein encoded by HCV.
Binds to the N-terminus within domain 1 of NS5A, which may cause structural distortions that interfere with NS5A functions, and thereby inhibits both viral RNA replication and virion assembly.
Note
Dakovir-C 60 60mg Tablet manufactured by Beximco Pharmaceuticals Ltd.. Its generic name is Daclatasvir. Dakovir-C 60 is availble in Bangladesh.
Farmaco BD drug index information on Dakovir-C 60 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.