Replivir 0.5 mg (Tablet)
Unit Price: ৳ 50.00 (1 x 10: ৳ 500.00)
Strip Price: ৳ 500.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Entecavir |
| Company | Beximco pharmaceuticals ltd |
| Also available as |
Indications
- Treatment of chronic hepatitis B virus infection in adults
- Treatment of chronic hepatitis B virus infection in pediatric patients 2 years and older
- Active viral replication
- Elevation in serum aminotransferases (ALT or AST)
- Histologically active disease
Pharmacology
- Competes with natural substrate deoxyguanosine triphosphate
- Inhibits all three activities of the HBV polymerase
- Base priming
- Reverse transcription of the negative strand from the pregenomic messenger RNA
- Synthesis of the positive strand of HBV DNA
Dosage & Administration
- Recommended dose: 0.5 mg once daily for nucleoside-treatment-naive adults and adolescents 16 years of age
- Recommended dose: 1 mg once daily for Lamivudine-refractory patients or patients with known Lamivudine or Telbivudine resistance mutations
- Recommended dose: 1 mg once daily for patients with decompensated liver disease (adult)
- Administration on an empty stomach
- Missed Dose: Skip the missed dose and take the next dose at the proper time
Interaction
- No significant drug interactions with Lamivudine or Adefovir dipivoxil
- Effects of co-administration with other drugs affecting renal function not evaluated
- Close monitoring for adverse events when coadministered with renal-affecting drugs
Contraindications
- Contraindicated in patients with demonstrated hypersensitivity to Entecavir
Side Effects
- Most common adverse events: headache, fatigue, dizziness, nausea
Pregnancy & Lactation
- No data on the effect on the transmission of HBV from mother to infant
- Appropriate care advised
- Not known whether it is excreted in human milk
- Instructions not to breastfeed if taking Entecavir
Precautions & Warnings
- Lactic acidosis reported with the use of nucleoside analogues alone or in combination with antiretrovirals
- Severe acute exacerbations of hepatitis B reported after discontinuation of treatment
Use in Special Populations
- Safety and effectiveness not established in pediatric patients below the age of 2 years
- Clinical studies did not include sufficient numbers of subjects aged 65 years and over
- Dose adjustment recommended for patients with renal impairment
- Dose adjustment guide provided for different levels of renal impairment
Overdose Effects
- No reported experience of Replivir overdosage in patients
- Healthy subjects received up to 20 mg daily for up to 14 days with no unexpected adverse events
- Monitoring for evidence of toxicity and standard supportive treatment advised in case of overdosage
Therapeutic Class
- Hepatic viral infections (Hepatitis B)
Storage Conditions
- Store below 30°C
- Protect from light
- Keep out of the reach of children