Dakovir-C
Generic Name
Daclatasvir + Sofosbuvir
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| dakovir c 60 mg tablet | ৳ 400.00 | ৳ 5,600.00 |
Description
Overview of the medicine
Dakovir-C is a fixed-dose combination of Daclatasvir and Sofosbuvir used for the treatment of chronic Hepatitis C virus (HCV) infection in adults. It's a direct-acting antiviral (DAA) that works by inhibiting viral replication.
Uses & Indications
Dosage
Adults
One tablet (Daclatasvir 60 mg/Sofosbuvir 400 mg) orally once daily with or without food for 12 weeks, or as determined by a physician based on genotype and cirrhosis status. Treatment duration may vary.
Elderly
No dosage adjustment is required for elderly patients.
Renal_impairment
No dosage adjustment is required for patients with mild or moderate renal impairment. For severe renal impairment (eGFR <30 mL/min/1.73m²) or end-stage renal disease (ESRD) requiring hemodialysis, use with caution and only if potential benefits outweigh risks, with close monitoring. Not recommended in these populations if alternative treatment options are available.
How to Take
Take orally once daily with or without food. Swallow the tablet whole; do not chew or crush it.
Mechanism of Action
Daclatasvir is an NS5A inhibitor, directly targeting and inhibiting the non-structural protein 5A (NS5A) essential for HCV replication. Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor, which, after being metabolized to its active uridine triphosphate form, inhibits HCV NS5B RNA polymerase, thereby blocking viral RNA replication.
Pharmacokinetics
Onset
Rapid onset of antiviral action, typically within days of initiating treatment.
Excretion
Daclatasvir: Primarily eliminated via feces (approx. 80%), with a smaller portion excreted in urine (approx. 6.6%). Sofosbuvir (metabolite GS-331007): Primarily eliminated via urine (approx. 80%), with a smaller portion in feces.
Half life
Daclatasvir: Approximately 12-15 hours. Sofosbuvir (active metabolite GS-331007): Approximately 18-19 hours.
Absorption
Daclatasvir is rapidly absorbed, with peak concentrations observed within 2 hours. Sofosbuvir is rapidly absorbed, with peak plasma concentrations of the parent compound observed within 0.5-2 hours. High-fat meal can slightly increase Sofosbuvir exposure.
Metabolism
Daclatasvir is primarily metabolized by CYP3A4. Sofosbuvir is extensively metabolized in the liver to its pharmacologically active nucleoside triphosphate form and then to an inactive metabolite (GS-331007).
Side Effects
Contraindications
- Hypersensitivity to Daclatasvir, Sofosbuvir, or any component of the tablet.
- Co-administration with potent CYP3A inducers (e.g., rifampin, rifabutin, phenytoin, carbamazepine, St. John's Wort) as they may significantly decrease Daclatasvir plasma concentrations, leading to loss of efficacy.
Drug Interactions
0
Amiodarone: Increased risk of bradycardia (refer to black box warning).
1
CYP3A inducers (e.g., rifampin, phenytoin): Contraindicated due to decreased Daclatasvir levels.
2
CYP3A inhibitors (e.g., ketoconazole, clarithromycin): May increase Daclatasvir levels; dosage adjustment may be needed for some inhibitors.
3
P-gp inducers (e.g., oxcarbazepine): May decrease Sofosbuvir levels.
4
Antacids/H2-receptor antagonists/PPIs: No clinically significant interaction reported for Sofosbuvir; for Daclatasvir, avoid concurrent use with omeprazole unless necessary.
5
Other antivirals (e.g., protease inhibitors, other DAAs): Potential for complex interactions; concurrent use generally not recommended unless specifically studied.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for overdose with Daclatasvir or Sofosbuvir. In case of overdose, the patient should be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic and supportive treatment should be instituted.
Pregnancy & Lactation
Pregnancy: Limited data on use in pregnant women. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation: It is unknown whether Daclatasvir or Sofosbuvir and its metabolites are excreted in human milk. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to Daclatasvir, Sofosbuvir, or any component of the tablet.
- Co-administration with potent CYP3A inducers (e.g., rifampin, rifabutin, phenytoin, carbamazepine, St. John's Wort) as they may significantly decrease Daclatasvir plasma concentrations, leading to loss of efficacy.
Drug Interactions
0
Amiodarone: Increased risk of bradycardia (refer to black box warning).
1
CYP3A inducers (e.g., rifampin, phenytoin): Contraindicated due to decreased Daclatasvir levels.
2
CYP3A inhibitors (e.g., ketoconazole, clarithromycin): May increase Daclatasvir levels; dosage adjustment may be needed for some inhibitors.
3
P-gp inducers (e.g., oxcarbazepine): May decrease Sofosbuvir levels.
4
Antacids/H2-receptor antagonists/PPIs: No clinically significant interaction reported for Sofosbuvir; for Daclatasvir, avoid concurrent use with omeprazole unless necessary.
5
Other antivirals (e.g., protease inhibitors, other DAAs): Potential for complex interactions; concurrent use generally not recommended unless specifically studied.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for overdose with Daclatasvir or Sofosbuvir. In case of overdose, the patient should be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic and supportive treatment should be instituted.
Pregnancy & Lactation
Pregnancy: Limited data on use in pregnant women. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation: It is unknown whether Daclatasvir or Sofosbuvir and its metabolites are excreted in human milk. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Available in pharmacies and hospitals
Approval Status
Approved by DGDA
Patent Status
Generic versions available due to compulsory licensing in Bangladesh
WHO Essential Medicine
YesClinical Trials
Dakovir-C (Daclatasvir + Sofosbuvir) has been evaluated in multiple Phase 3 clinical trials demonstrating high sustained virologic response (SVR) rates across various HCV genotypes, including difficult-to-treat populations.
Lab Monitoring
- HCV RNA levels (before, during, and after treatment to assess response)
- Liver function tests (ALT, AST, bilirubin) at baseline and periodically during treatment.
- Renal function tests (eGFR, creatinine) at baseline and periodically if impairment is suspected or existing.
Doctor Notes
- Confirm HCV genotype and assess liver disease stage before initiating treatment.
- Screen for potential drug-drug interactions, particularly with amiodarone and potent CYP3A inducers.
- Educate patients on the importance of adherence to the full treatment course and potential for reinfection.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor and complete the full course of treatment, even if you feel better.
- Do not stop taking Dakovir-C without consulting your doctor.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, especially amiodarone.
Missed Dose Advice
If a dose is missed and it has been less than 20 hours since the usual time, take it as soon as possible. If more than 20 hours have passed, skip the missed dose and take the next dose at the regularly scheduled time. Do not take a double dose to make up for a missed dose.
Driving Precautions
Some patients may experience dizziness, fatigue, or visual disturbances. If these occur, exercise caution when driving or operating machinery.
Lifestyle Advice
- Avoid alcohol consumption as it can worsen liver disease.
- Maintain a healthy diet and lifestyle.
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