Daclacee
Generic Name
Daclatasvir 60 mg tablet
Manufacturer
Beacon Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
daclacee 60 mg tablet | ৳ 400.00 | ৳ 4,000.00 |
Description
Overview of the medicine
Daclatasvir is a direct-acting antiviral medication used in combination with other drugs to treat chronic hepatitis C virus (HCV) infection. It targets the NS5A protein, which is essential for HCV replication.
Uses & Indications
Dosage
Adults
60 mg orally once daily, in combination with other agents (e.g., Sofosbuvir). Duration typically 12 or 24 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.
Elderly
No specific dose adjustment is generally needed for elderly patients.
Renal_impairment
No dose adjustment is needed for patients with any degree of renal impairment, including those on dialysis.
How to Take
Oral administration. Can be taken with or without food. Should be taken at the same time each day.
Mechanism of Action
Daclatasvir inhibits the hepatitis C virus (HCV) nonstructural protein 5A (NS5A), a phosphoprotein that plays a critical role in HCV replication, including viral RNA replication and virion assembly.
Pharmacokinetics
Onset
Not an acute onset drug; viral load reduction begins within days of starting treatment.
Excretion
Primarily via feces (approx. 88%), with a smaller amount in urine (approx. 6.6%).
Half life
Approximately 12-15 hours.
Absorption
Rapidly absorbed, peak plasma concentration typically 2 hours post-dose. Bioavailability around 67%.
Metabolism
Primarily metabolized by cytochrome P450 3A4 (CYP3A4).
Side Effects
Contraindications
- Hypersensitivity to daclatasvir or any component of the formulation.
- Co-administration with strong inducers of CYP3A (e.g., rifampin, phenytoin, carbamazepine, St. John's wort) due to potential for loss of efficacy.
Drug Interactions
Amiodarone
Co-administration with sofosbuvir and another direct-acting antiviral, including daclatasvir, may lead to symptomatic bradycardia; co-administration is not recommended.
Ketoconazole, Clarithromycin, Ritonavir
Strong CYP3A inhibitors, co-administration may increase daclatasvir plasma concentrations, requiring dose reduction in some cases.
Rifampin, Phenytoin, Carbamazepine, St. John's wort
Strong CYP3A inducers, co-administration is contraindicated due to decreased daclatasvir plasma concentrations and potential for loss of virologic response.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Limited experience with overdose. In cases of overdose, treatment should be symptomatic and supportive. Daclatasvir cannot be efficiently removed by hemodialysis.
Pregnancy & Lactation
Pregnancy Category B. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if daclatasvir is excreted in human milk; advise women not to breastfeed during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from the date of manufacture, depending on storage conditions.
Availability
Pharmacies, hospitals
Approval Status
FDA approved
Patent Status
Patent expired in many countries; generic versions available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials (e.g., ALLY-1, ALLY-2, ALLY-3, ALLY-4 studies) demonstrated high sustained virologic response (SVR) rates across various HCV genotypes when daclatasvir was used in combination with sofosbuvir or other antiviral agents.
Lab Monitoring
- HCV RNA levels (to assess viral response)
- Liver function tests (ALT, AST, bilirubin) prior to and during treatment
- Renal function tests if clinically indicated
- HBV serology testing before starting treatment
Doctor Notes
- Always use daclatasvir in combination with other appropriate antiviral agents for HCV treatment.
- Ensure patients are screened for HBV infection before initiating therapy due to the risk of HBV reactivation.
- Strict adherence to the dosing regimen is crucial for achieving sustained virologic response.
- Monitor for drug interactions, especially with strong CYP3A inducers/inhibitors and amiodarone.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor, at the same time each day.
- Do not stop taking Daclatasvir without consulting your doctor, even if you feel better.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Report any severe side effects, especially slow heart rate if also taking amiodarone.
Missed Dose Advice
If a dose is missed and it is within 12 hours of the usual dosing time, take the missed dose as soon as possible. If it is more than 12 hours, skip the missed dose and resume the regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Daclatasvir may cause dizziness or fatigue. Patients should be advised not to drive or operate machinery if they experience these symptoms.
Lifestyle Advice
- Avoid alcohol consumption during treatment.
- Maintain a healthy diet and lifestyle as advised by your doctor.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.