Daclac Tablet
Daclatasvir
60mg
Hetero Drugs Ltd.
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| Retail Price | 5800.00 NPR |
Indications
Daclac Tablet is used for:
Chronic hepatitis C virus infection in adults.
Adult Dose
Hepatitis C
Indicated for use with sofosbuvir for chronic hepatitis C virus (HCV) genotypes 1 and 3 infection
Genotype 1
Without cirrhosis or with compensated (Child-Pugh A) cirrhosis: 60 mg (plus sofosbuvir 400 mg) PO qDay for 12 weeks
Decompensated (Child-Pugh B or C) cirrhosis or posttransplant: 60 mg (plus sofosbuvir 400 mg) PO qDay plus ribavirin for 12 weeks
Genotype 3
Without cirrhosis: 60 mg (plus sofosbuvir 400 mg) PO qDay for 12 weeks
Compensated (Child-Pugh A) or decompensated (Child-Pugh B or C) cirrhosis, or posttransplant: 60 mg (plus sofosbuvir 400 mg) PO qDay plus ribavirin for 12 weeks
Hepatic impairment (any degree): No dose adjustment required
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
Patients w/ genotype 1 infection & compensated cirrhosis; receiving amiodarone; decompensated liver disease; prior exposure to a NS5A inhibitor; pre-, peri- or post-liver transplant or other organ transplant; HIV/HCV, HBV co-infected patients.
Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Women of childbearing potential. Pregnancy & lactation. Childn & adolescents <18 yr.
Lactation
Unknown if distributed in human breast milk
Pregnancy-Lactation
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
Daclac 60mg Tablet manufactured by Hetero Drugs Ltd.. Its generic name is Daclatasvir. Daclac is availble in Nepal.
Farmaco Nepal drug index information on Daclac Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.