Dakla 60 mg
Daclatasvir
Category: Tablet
Manufacturer: Healthcare Pharmacuticals Ltd.
Price: 2800.0 ৳
7's pack
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Daclatasvir is indicated in combination with Sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infection in adults.
Hepatic viral infections (Hepatitis C)
Daclatasvir stops HCV viral RNA replication and protein translation by directly inhibiting HCV protein NS5A. NS5A is critical for HCV viral transcription and translation.
The recommended dose of Daclatasvir is 60 mg once daily, to be taken orally with or without meals. Daclatasvir must be administered in combination with other medicinal products.HCV-monoinfected or HCV/HIV coinfected patients with chronic hepatitis C without cirrhosis, including treatment-naïve patients and patients who failed on a treatment based on Peginterferon alfa & Ribavirin
All genotypes: Daclatasvir + Sofosbuvir for 12 weeks
HCV-monoinfected or HCV/HIV coinfected patients with chronic hepatitis C with compensated (Child-Pugh A) cirrhosis, including treatment-naïve patients and patients who failed on a treatment based on Peginterferon alfa & Ribavirin
Genotype 1,4,5,6: Daclatasvir + Sofosbuvir for 24 weeks or Daclatasvir + Sofosbuvir + Ribavirin for 12 weeks
Genotype 2: Daclatasvir + Sofosbuvir for 12 weeks
Genotype 3: Daclatasvir + Sofosbuvir + Ribavirin for 24 week
The dose of Ribavirin, when combined with Daclatasvir, is weight-based (1000 or 1200 mg in patients <75 kg or ≥75 kg, respectively).
Potential for Other Drugs to Affect Daclatasvir: Daclatasvir is a substrate of CYP3A. Therefore, moderate or strong inducers of CYP3A may decrease the plasma levels and therapeutic effect of Daclatasvir. Strong inhibitors of CYP3A (eg, clarithromycin, itraconazole, ketoconazole, ritonavir) may increase the plasma levels of Daclatasvir. Potential for Daclatasvir to Affect Other Drugs: Daclatasvir is an inhibitor of P-glycoprotein transporter (P-gp), organic anion transporting polypeptide (OATP) 1B1 and 1B3, and breast cancer resistance protein (BCRP). Administration of Daclatasvir may increase systemic exposure to medicinal products that are substrates of P-gp, OATP 1B1 or 1B3, or BCRP, which could increase or prolong their therapeutic effect or adverse reaction.
Daclatasvir is contraindicated in combination with drugs that strongly induce CYP3A and, thus, may lead to lower exposure and loss of efficacy of Daclatasvir. Contraindicated drugs include, but are not limited to, Anticonvulsants (phenytoin, carbamazepine), Antimycobacterial agents (rifampin), Herbal Products st.Jhon’s wort (Hypericum perforatum).
The following serious adverse reactions are described below and elsewhere in the labeling: Serious Symptomatic Bradycardia When Coadministered with Sofosbuvir and Amiodarone. One can get any of the following symptoms: Fainting or near-fainting, dizziness or lightheadedness, not feeling well, weakness, tiredness, shortness of breath, chest pain, confusion, memory problems.
Daclatasvir should not be used during pregnancy or in women of childbearing potential not using contraception. Use of highly effective contraception should be continued for 5 weeks after completion of Daclatasvir therapy. It is not known whether daclatasvir is excreted in human milk.
Risk of adverse reactions or loss of virologic response due to drug interactions. The concomitant use of Daclatasvir and other drugs may result in known or potentially significant drug interactions, some of which may lead to:
loss of therapeutic effect of Daclatasvir and possible development of resistance
dosage adjustments of concomitant medications or Daclatasvir
possible clinically significant adverse reactions from greater exposures of concomitant drugs or Daclatasvir
Serious Symptomatic Bradycardia When Coadministered with Sofosbuvir and Amiodarone and patients counseling: Postmarketing cases of symptomatic bradycardia and cases requiring pacemaker intervention have been reported when Amiodarone is coadministered with Sofosbuvir in combination with another HCV direct-acting antiviral, including Daclatasvir. Patients who are taking Sofosbuvir in combination with Daclatasvir who need to start Amiodarone therapy due to no other alternative treatment options should undergo cardiac monitoring.
There is no known antidote for overdose of Daclatasvir. Treatment of overdose with Daclatasvir should consist of general supportive measures, including monitoring of vital signs and observation of the patient’s clinical status. Because Daclatasvir is highly protein bound (>99%), dialysis is unlikely to significantly reduce plasma concentrations of the drug.
Store at room temperature below 30°C, protect from light. keep out of the reach of children.
Hepatic viral infections (Hepatitis C)
Daclatasvir is a direct acting antiviral agent (DAA) against the Hepatitis C Virus (HCV). Daclatasvir is an inhibitor of NS5A, a nonstructural protein encoded by HCV. Daclatasvir binds to the N-terminus of NS5A and inhibits both viral RNA replication and virion assembly. Characterization of Daclatasvir-resistant viruses, biochemical studies, and computer modeling data indicate that Daclatasvir interacts with the N-terminus within Domain 1 of the protein, which may cause structural distortions that interfere with NS5A functions.
No data with Daclatasvir in pregnant women are available to inform a drug-associated risk. No information regarding the presence of Daclatasvir in human milk, the effects on the breastfed infant, or the effects on milk production is available.
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