Teviral
Generic Name
Entecavir
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| teviral 05 mg tablet | ৳ 50.00 | ৳ 500.00 |
Description
Overview of the medicine
Teviral 0.5 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 with evidence of active viral replication and persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Uses & Indications
Dosage
Adults
0.5 mg once daily. For lamivudine-refractory patients, 1 mg once daily.
Elderly
No dosage adjustment required based on age alone, but monitor renal function.
Renal_impairment
Dosage adjustment is recommended for patients with creatinine clearance < 50 mL/min.
How to Take
Should be taken on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).
Mechanism of Action
Entecavir is a guanosine nucleoside analogue with activity against hepatitis B virus (HBV) polymerase. It is phosphorylated to the active triphosphate form, which competes with the natural substrate, deoxyguanosine triphosphate, for incorporation into HBV DNA. This competition inhibits all three functions of the HBV polymerase: base priming, reverse transcription of the negative strand from the pregenomic messenger RNA, and synthesis of the positive strand of HBV DNA. This leads to inhibition of viral replication.
Pharmacokinetics
Onset
Viral load reduction can be observed within weeks; sustained viral suppression achieved with continued therapy.
Excretion
Primarily excreted unchanged in the urine, with approximately 62-73% of a single dose recovered in urine.
Half life
Terminal plasma half-life is approximately 128-149 hours due to intracellular triphosphate, while apparent plasma elimination half-life is 15-20 hours.
Absorption
Rapidly absorbed after oral administration, with peak plasma concentrations occurring between 0.5 to 1.5 hours.
Metabolism
Not a substrate, inducer, or inhibitor of cytochrome P450 enzymes. Primarily metabolized by phosphorylation to its active triphosphate form.
Side Effects
Contraindications
- Hypersensitivity to Entecavir or any components of the formulation.
Drug Interactions
CYP450 metabolized drugs
No significant pharmacokinetic interactions expected with drugs metabolized by CYP450 enzymes.
Drugs affecting renal function
Drugs that reduce renal function or compete for active tubular secretion (e.g., adefovir, tenofovir, ribavirin) may increase entecavir concentrations.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited experience with overdose. Monitor for signs of toxicity and provide supportive care. Hemodialysis removes approximately 13% of the entecavir dose over 4 hours.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactating mothers should discontinue nursing or the drug, considering the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date.
Availability
Pharmacies, hospitals
Approval Status
FDA Approved
Patent Status
Generic versions available, original patent expired
WHO Essential Medicine
YesClinical Trials
Multiple pivotal clinical trials demonstrated entecavir's efficacy and safety in chronic HBV patients, including treatment-naive and lamivudine-refractory individuals. Key trials include AI463-014 and AI463-022.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin)
- Renal function (creatinine, eGFR)
- HBV DNA levels
- HIV status (before initiating therapy)
Doctor Notes
- Screen all patients for HIV before initiating entecavir due to the risk of HIV resistance if undiagnosed HIV is treated with entecavir alone.
- Monitor renal function regularly.
- Emphasize strict adherence to avoid resistance.
Patient Guidelines
- Take on an empty stomach.
- Do not stop the medication without consulting your doctor.
- Report any new or worsening symptoms immediately.
- Regular monitoring by your doctor is essential.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double the dose.
Driving Precautions
May cause dizziness or fatigue; use caution when driving or operating machinery.
Lifestyle Advice
- Maintain a healthy diet and lifestyle.
- Avoid alcohol consumption.
- Regular exercise.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.