Virodacla
Generic Name
Daclatasvir 60 mg Tablet
Manufacturer
XYZ Pharmaceuticals
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| virodacla 60 mg tablet | ৳ 400.00 | ৳ 1,600.00 |
Description
Overview of the medicine
Daclatasvir is a direct-acting antiviral medication used in combination with other antiviral drugs to treat chronic hepatitis C virus (HCV) infection. It targets the NS5A protein, essential for HCV replication.
Uses & Indications
Dosage
Adults
60 mg once daily, in combination with Sofosbuvir, for 12 or 24 weeks depending on genotype and cirrhosis status.
Elderly
No specific dose adjustment required.
Renal_impairment
No dose adjustment required for mild, moderate, or severe renal impairment, or for patients on dialysis.
How to Take
Administer orally, with or without food. Swallow the tablet whole. Do not chew, crush, or break.
Mechanism of Action
Daclatasvir is an NS5A inhibitor. It binds to the HCV NS5A protein, which is a key component of the viral replication complex. By inhibiting NS5A, it prevents viral RNA replication and virion assembly.
Pharmacokinetics
Onset
Rapid, with significant reduction in HCV RNA levels observed within days.
Excretion
Primarily excreted in feces (approximately 80%), with a minor amount in urine (approximately 6.6%).
Half life
Approximately 12-15 hours.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations (Tmax) usually within 1-2 hours. Bioavailability is approximately 67%.
Metabolism
Primarily metabolized by CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Co-administration with strong inducers of CYP3A4 (e.g., rifampicin, phenytoin, carbamazepine, St. John's wort) due to risk of significantly lower plasma exposure and loss of efficacy.
Drug Interactions
Atazanavir/Ritonavir
Increased daclatasvir concentrations.
Amiodarone (with Sofosbuvir)
Risk of severe symptomatic bradycardia.
Strong CYP3A4 inducers (e.g., Rifampicin, Phenytoin)
Significantly reduce daclatasvir plasma concentrations, leading to loss of therapeutic effect. Co-administration is contraindicated.
Strong CYP3A4 inhibitors (e.g., Ketoconazole, Clarithromycin)
May increase daclatasvir concentrations. Dose adjustment of daclatasvir (e.g., 30 mg) might be needed.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. In case of overdose, monitor for adverse effects and provide supportive care. Daclatasvir is highly protein-bound, so hemodialysis is unlikely to remove a significant amount.
Pregnancy & Lactation
Pregnancy: Limited data. Use only if potential benefit justifies potential risk to the fetus. Recommend effective contraception during treatment. Lactation: Unknown if excreted in human milk. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from daclatasvir therapy.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Pharmacies, hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, EMA, DGDA)
Patent Status
Patent protected in some regions, generics available in others
WHO Essential Medicine
YesClinical Trials
Daclatasvir has been extensively studied in several clinical trials (e.g., ALLY-1, ALLY-2, ALLY-3) demonstrating its efficacy and safety in various HCV genotypes and patient populations, including those with cirrhosis and HIV/HCV co-infection.
Lab Monitoring
- HCV RNA levels (viral load) at baseline, week 4, and 12-24 weeks post-treatment (SVR).
- Liver function tests (ALT, AST, bilirubin) at baseline and periodically during treatment.
- Renal function tests (creatinine, eGFR) at baseline.
- Complete blood count (CBC) if co-administered with ribavirin.
Doctor Notes
- Always use in combination with Sofosbuvir or other appropriate antivirals.
- Careful monitoring for drug interactions, especially with strong CYP3A4 modulators and amiodarone.
- Educate patients on adherence to therapy and potential side effects.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Do not stop treatment early, as it may lead to treatment failure.
- Report any severe side effects immediately to your doctor.
- Attend all scheduled medical appointments and lab tests.
Missed Dose Advice
If a dose is missed and it's within 20 hours of the scheduled time, take it as soon as possible. If it's more than 20 hours, skip the missed dose and take the next dose at the regularly scheduled time. Do not double the dose.
Driving Precautions
May cause fatigue or dizziness. Patients should be advised not to drive or operate machinery if they experience these symptoms.
Lifestyle Advice
- Avoid alcohol during treatment, as it can worsen liver damage.
- Maintain a healthy diet and lifestyle.
- Discuss all other medications and supplements with your doctor to avoid interactions.
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Global Brand Names
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