Barcavir
Generic Name
Entecavir
Manufacturer
Healthcare Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| barcavir 1 mg tablet | ৳ 90.00 | ৳ 900.00 |
| barcavir 05 mg tablet | ৳ 48.00 | ৳ 480.00 |
Description
Overview of the medicine
Barcavir (Entecavir) is an antiviral medication used to treat chronic hepatitis B virus (HBV) infection in adults and pediatric patients aged 2 years and older with evidence of active viral replication and persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Uses & Indications
Dosage
Adults
For nucleoside-naïve adult patients: 0.5 mg once daily. For lamivudine-refractory adult patients or patients with known lamivudine resistance: 1 mg once daily.
Elderly
No dose adjustment required based on age; however, renal function should be monitored due to age-related decline in renal function.
Renal_impairment
Dose adjustment required based on creatinine clearance: CrCl ≥50 mL/min: 0.5 mg (naïve) or 1 mg (refractory) once daily. CrCl 30-<50 mL/min: 0.25 mg (naïve) or 0.5 mg (refractory) once daily. CrCl <30 mL/min or hemodialysis/CAPD: 0.15 mg (naïve) or 0.25 mg (refractory) once daily or every other day depending on severity.
How to Take
Barcavir should be taken orally on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal) to ensure optimal absorption.
Mechanism of Action
Entecavir is a guanosine analogue that is phosphorylated to its active triphosphate form. Entecavir triphosphate competes with the natural substrate deoxyguanosine triphosphate, inhibiting all three functions of the HBV polymerase: (1) base priming, (2) reverse transcription of the negative strand from the pregenomic messenger RNA, and (3) synthesis of the positive strand of HBV DNA.
Pharmacokinetics
Onset
Viral load reduction typically observed within weeks, with continued reduction over months.
Excretion
Primarily renal. Approximately 62-73% of a dose is excreted unchanged in urine.
Half life
Terminal elimination half-life is 128-149 hours. Intracellular half-life of entecavir triphosphate is 15 hours.
Absorption
Rapidly absorbed. Peak plasma concentrations reached within 0.5-1.5 hours. Oral bioavailability is approximately 100% relative to solution. Food decreases absorption (AUC decreased by 18-20%, Cmax decreased by 44-46%).
Metabolism
Not a substrate, inhibitor, or inducer of cytochrome P450 enzymes. Not significantly metabolized by liver.
Side Effects
Contraindications
- Hypersensitivity to entecavir or any component of the formulation.
- Patients co-infected with HIV and HBV who are not receiving effective HIV treatment.
Drug Interactions
Drugs eliminated by renal excretion (e.g., lamivudine, adefovir, tenofovir)
Coadministration with entecavir may increase serum concentrations of entecavir or the coadministered drug due to competition for renal tubular secretion. Monitor for adverse effects.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited experience with entecavir overdose. In studies, single doses up to 40 mg and multiple doses up to 20 mg/day for up to 28 days were well tolerated. There is no specific antidote for entecavir overdose. Hemodialysis removes approximately 13% of the dose in 4 hours.
Pregnancy & Lactation
Pregnancy Category C. Entecavir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether entecavir is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to entecavir or any component of the formulation.
- Patients co-infected with HIV and HBV who are not receiving effective HIV treatment.
Drug Interactions
Drugs eliminated by renal excretion (e.g., lamivudine, adefovir, tenofovir)
Coadministration with entecavir may increase serum concentrations of entecavir or the coadministered drug due to competition for renal tubular secretion. Monitor for adverse effects.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited experience with entecavir overdose. In studies, single doses up to 40 mg and multiple doses up to 20 mg/day for up to 28 days were well tolerated. There is no specific antidote for entecavir overdose. Hemodialysis removes approximately 13% of the dose in 4 hours.
Pregnancy & Lactation
Pregnancy Category C. Entecavir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether entecavir is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to 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 to 36 months from manufacturing date, refer to packaging for exact expiry.
Availability
Available in pharmacies and hospitals
Approval Status
FDA approved, DGDA approved
Patent Status
Generics available, original patent expired
WHO Essential Medicine
YesClinical Trials
Entecavir has undergone extensive clinical trials demonstrating its efficacy and safety in chronic hepatitis B patients, including nucleoside-naïve and lamivudine-refractory individuals, leading to sustained viral suppression and improved liver outcomes.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin)
- Renal function tests (creatinine, creatinine clearance)
- HBV DNA levels
- HBeAg and anti-HBe status
- HBsAg and anti-HBs status
- Lactic acid levels (if symptoms of lactic acidosis occur)
Doctor Notes
- Emphasize strict adherence to dosing regimen to prevent resistance.
- Assess renal function before and during therapy; adjust dose for impaired renal function.
- Test all patients for HIV infection prior to initiating Barcavir. If Barcavir is used in HBV/HIV co-infected patients, ensure concurrent effective antiretroviral therapy for HIV.
- Educate patients on symptoms of lactic acidosis and hepatic flares.
- Monitor HBV DNA, ALT, and HBeAg/anti-HBe status regularly.
- Counsel pregnant patients on risks and benefits.
Patient Guidelines
- Take Barcavir exactly as prescribed by your doctor. Do not stop taking it without consulting your doctor, as this can lead to severe worsening of your hepatitis B.
- Take Barcavir on an empty stomach for optimal absorption.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Report any unusual symptoms or side effects to your doctor immediately.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Barcavir may cause dizziness or fatigue in some patients. If you experience these symptoms, avoid driving or operating heavy machinery until you know how the medication affects you.
Lifestyle Advice
- Avoid or limit alcohol consumption to reduce stress on your liver.
- Maintain a healthy diet and engage in regular exercise.
- Practice safe sex to prevent transmission of HBV and other sexually transmitted infections.
- Regularly visit your doctor for scheduled check-ups and lab tests.
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