Teviral
Generic Name
Entecavir
Manufacturer
Beacon Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| teviral 1 mg tablet | ৳ 100.30 | ৳ 1,003.00 |
Description
Overview of the medicine
Teviral 1 mg Tablet contains Entecavir, an antiviral medication used to treat chronic hepatitis B virus (HBV) infection in adults and children aged 2 years and older. It helps reduce the amount of HBV in the body and improves liver function.
Uses & Indications
Dosage
Adults
For nucleoside-naive patients: 0.5 mg once daily. For lamivudine-refractory patients or patients with known lamivudine resistance: 1 mg once daily.
Elderly
No dose adjustment based on age alone. Adjust based on renal function if impaired.
Renal_impairment
Dosage adjustment is required for patients with creatinine clearance < 50 mL/min, including hemodialysis or CAPD. Consult product leaflet for specific dose adjustments.
How to Take
Take orally, preferably on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal). Take at the same time each day.
Mechanism of Action
Entecavir is a guanosine nucleoside analog that is phosphorylated to its active triphosphate form. Entecavir triphosphate inhibits all three activities of the HBV polymerase (reverse transcriptase): base priming, reverse transcription of the negative strand from the pregenomic messenger RNA, and synthesis of the positive strand of HBV DNA. It directly interferes with viral replication.
Pharmacokinetics
Onset
Antiviral effects begin within days to weeks, significant reduction in viral load observed within 4-8 weeks.
Excretion
Primarily excreted by the kidneys, with approximately 62-73% of the administered dose recovered in urine as unchanged drug.
Half life
Elimination half-life is approximately 128-149 hours due to intracellular retention of the triphosphate. Plasma half-life is 15 hours.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations occur between 0.5 to 1.5 hours. Bioavailability is approximately 100% when taken without food.
Metabolism
Not a substrate, inhibitor, or inducer of cytochrome P450 enzymes. Primarily eliminated unchanged.
Side Effects
Contraindications
- Hypersensitivity to entecavir or any component of the formulation.
- Lactation (potentially).
Drug Interactions
Drugs eliminated by renal excretion
Coadministration with drugs that reduce renal function or compete for active tubular secretion (e.g., adefovir, tenofovir, ribavirin) may increase serum concentrations of entecavir or the coadministered drug.
Storage
Store at controlled room temperature (20°C to 25°C), excursions permitted to 15°C to 30°C. Protect from moisture and light. Keep out of reach of children.
Overdose
Limited experience with entecavir overdose. Monitor for signs of toxicity and provide supportive care. Hemodialysis removes approximately 13% of the dose over 4 hours.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies potential risk to the fetus. Lactation: Not recommended; unknown if excreted in human milk. Breastfeeding is not recommended for mothers infected with HBV to avoid postnatal transmission to the infant.
Side Effects
Contraindications
- Hypersensitivity to entecavir or any component of the formulation.
- Lactation (potentially).
Drug Interactions
Drugs eliminated by renal excretion
Coadministration with drugs that reduce renal function or compete for active tubular secretion (e.g., adefovir, tenofovir, ribavirin) may increase serum concentrations of entecavir or the coadministered drug.
Storage
Store at controlled room temperature (20°C to 25°C), excursions permitted to 15°C to 30°C. Protect from moisture and light. Keep out of reach of children.
Overdose
Limited experience with entecavir overdose. Monitor for signs of toxicity and provide supportive care. Hemodialysis removes approximately 13% of the dose over 4 hours.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies potential risk to the fetus. Lactation: Not recommended; unknown if excreted in human milk. Breastfeeding is not recommended for mothers infected with HBV to avoid postnatal transmission to the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture.
Availability
Pharmacies, hospitals
Approval Status
Approved by FDA and DGDA
Patent Status
Generic versions available, patent expired
WHO Essential Medicine
YesClinical Trials
Entecavir has undergone extensive clinical trials demonstrating its efficacy and safety in chronic HBV infection, including studies comparing it to lamivudine and placebo, and studies in lamivudine-refractory patients.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin) at baseline and periodically during treatment.
- Renal function (creatinine clearance) at baseline and periodically.
- HBV DNA levels periodically.
- Hepatitis B e-antigen (HBeAg) and anti-HBe status.
Doctor Notes
- Monitor patients carefully for signs of lactic acidosis and hepatic toxicity.
- Regular assessment of HBV DNA and liver function is essential to monitor treatment response and detect resistance.
- Advise patients on the importance of adherence to therapy and not to discontinue without medical consultation due to the risk of HBV exacerbation.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Do not stop taking this medicine without consulting your doctor, as it can lead to severe exacerbation of hepatitis B.
- Inform your doctor about all other medications and supplements you are taking.
- Report any new or worsening symptoms to your doctor immediately.
Missed Dose Advice
If a dose is missed, take it as soon as remembered, unless it is almost time for the next dose. Do not double the dose to catch up.
Driving Precautions
May cause dizziness or fatigue. If affected, avoid driving or operating machinery.
Lifestyle Advice
- Avoid alcohol consumption.
- Maintain a healthy diet and lifestyle.
- Practice safe sex to prevent HBV transmission.
- Regular follow-ups with your doctor are crucial.
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International brand names for this medicine. Click a brand to search for detailed information.
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