Tecavir
Generic Name
tecavir-05-mg-tablet
Manufacturer
Various manufacturers (e.g., Incepta Pharmaceuticals)
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tecavir 05 mg tablet | ৳ 40.00 | ৳ 400.00 |
Description
Overview of the medicine
Entecavir is an oral antiviral agent used in the treatment of chronic hepatitis B virus (HBV) infection. It works by inhibiting the HBV DNA polymerase, thereby reducing viral replication.
Uses & Indications
Dosage
Adults
Nucleoside-naive adult patients: 0.5 mg once daily. Lamivudine-refractory adult patients or those with known lamivudine resistance mutations: 1 mg once daily.
Elderly
No specific dose adjustment is needed based on age; however, monitor renal function.
Renal_impairment
Dose adjustment required based on creatinine clearance (CrCl). For CrCl < 50 mL/min (including hemodialysis or CAPD), dose frequency reduction or dose reduction is necessary.
How to Take
Administer 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 nucleoside analogue with activity against HBV DNA polymerase. It is phosphorylated to its active triphosphate form, which competes with the natural substrate deoxyguanosine triphosphate, leading to inhibition of HBV reverse transcriptase (RT) activity, including DNA priming, reverse transcription of the negative strand, and synthesis of the positive strand of HBV DNA.
Pharmacokinetics
Onset
Viral DNA suppression typically within weeks of starting treatment.
Excretion
Primarily excreted unchanged by the kidneys (62-73% of a single dose).
Half life
Terminal elimination half-life is about 128-149 hours; intracellular triphosphate half-life is approximately 15 hours.
Absorption
Rapidly absorbed, peak plasma concentrations (Cmax) occur between 0.5 and 1.5 hours. Bioavailability is approximately 100% when taken without food. Food decreases absorption.
Metabolism
Not a substrate, inhibitor, or inducer of CYP450 enzymes. Not significantly metabolized.
Side Effects
Contraindications
- Hypersensitivity to entecavir or any component of the formulation.
Drug Interactions
Drugs affecting renal function or competing for active tubular secretion (e.g., Tenofovir, Lamivudine, Adefovir)
Co-administration may increase serum concentrations of entecavir or the co-administered drug, requiring close monitoring or dose adjustment.
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 case of overdose, patients should be monitored for signs of toxicity, and standard supportive treatment should be administered. Hemodialysis removes approximately 13% of the dose over 4 hours.
Pregnancy & Lactation
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. It is unknown whether entecavir is excreted in human milk; a decision should be made whether to discontinue nursing or to discontinue the drug.
Side Effects
Contraindications
- Hypersensitivity to entecavir or any component of the formulation.
Drug Interactions
Drugs affecting renal function or competing for active tubular secretion (e.g., Tenofovir, Lamivudine, Adefovir)
Co-administration may increase serum concentrations of entecavir or the co-administered drug, requiring close monitoring or dose adjustment.
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 case of overdose, patients should be monitored for signs of toxicity, and standard supportive treatment should be administered. Hemodialysis removes approximately 13% of the dose over 4 hours.
Pregnancy & Lactation
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. It is unknown whether entecavir is excreted in human milk; a decision should be made whether to discontinue nursing or to discontinue the drug.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date
Availability
Available in pharmacies nationwide
Approval Status
FDA/DGDA Approved
Patent Status
Generics available, patent expired in many regions
WHO Essential Medicine
YesClinical Trials
Entecavir has undergone extensive clinical trials demonstrating its efficacy and safety in suppressing HBV DNA, improving liver histology, and reducing the risk of disease progression in patients with chronic hepatitis B.
Lab Monitoring
- HBV DNA levels
- HBeAg/anti-HBe status
- Liver function tests (ALT, AST, bilirubin)
- Renal function (creatinine, CrCl)
- Lactic acid (if symptoms suggest)
Doctor Notes
- Monitor liver and renal function regularly, especially for patients with pre-existing renal impairment.
- Counsel patients on strict adherence to the regimen and the risk of hepatitis flare-up upon discontinuation.
- Educate patients about the black box warnings.
Patient Guidelines
- Take medication exactly as prescribed by your doctor.
- Do not stop treatment without consulting your doctor, as it can lead to a severe flare-up of hepatitis B.
- Report any unusual symptoms or side effects immediately.
- Do not share this medication with others.
- Attend all regular follow-up appointments.
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 take two doses at the same time or double the dose to make up for a missed one.
Driving Precautions
Entecavir may cause dizziness or fatigue. Patients should use caution when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Avoid alcohol consumption.
- Maintain a healthy diet and regular exercise.
- Practice safe sex to prevent transmission of HBV.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.