Teviral 0.05 mg/ml (Oral Solution)
70 ml bottle: ৳ 220.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Entecavir |
| Company | Aci limited |
| Also available as |
Indications
- Indicated for the treatment of chronic hepatitis B virus infection in adults
- Indicated for the treatment of chronic hepatitis B virus infection in pediatric patients 2 years of age and older
- Evidence of active viral replication
- Evidence of persistent elevation in serum aminotransferases (ALT or AST)
- Histologically active disease
Pharmacology
- Competes with the natural substrate deoxyguanosine triphosphate
- Functionally inhibits all three activities of the HBV polymerase
- Inhibits base priming
- Inhibits reverse transcription of the negative strand from the pregenomic messenger RNA
- Inhibits synthesis of the positive strand of HBV DNA
- Activated by kinases and can be incorporated into the DNA
- Ultimate effect of inhibiting the HBV polymerase activity
Dosage & Administration
- Recommended dose of Entecavir for chronic hepatitis B virus infection in nucleoside-treatment-naive adults and adolescents 16 years of age is 0.5 mg once daily
- Recommended dose of Entecavir for Lamivudine-refractory or known Lamivudine or Telbivudine resistance mutations is 1 mg once daily
- Recommended dose of Entecavir for patients with decompensated liver disease (adult) is 1 mg once daily
- Entecavir should be administered on an empty stomach
- Missed dose should be skipped and not compensated with a double dose
Interaction
- Co-administration with Lamivudine or Adefovir dipivoxil did not result in significant drug interactions
- Effects of co-administration with other drugs that are eliminated through renal or affect renal function have not been evaluated
Contraindications
- Contraindicated in patients with previously demonstrated hypersensitivity to Entecavir or any component of the product
Side Effects
- The most common adverse events are headache, fatigue, dizziness, and nausea
Pregnancy & Lactation
- No data on the effect of Entecavir on the transmission of HBV from mother to infant
- Mothers should be instructed not to breastfeed if they are taking Entecavir
Precautions & Warnings
- Lactic acidosis and severe hepatomegaly with steatosis reported with the use of nucleoside analogues alone or in combination with antiretrovirals
- Severe acute exacerbations of hepatitis B reported in patients who have discontinued anti-hepatitis B therapy
Use in Special Populations
- Safety and effectiveness in pediatric patients below the age of 2 years have not been established
- Clinical studies did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects
- Dose adjustment recommended for patients with CrCl <50 ml/min including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD)
Overdose Effects
- No experience of Teviral overdosage reported in patients
- Healthy subjects who received up to 20 mg daily for up to 14 days and single doses up to 40 mg had no unexpected adverse events
- Patient must be monitored for evidence of toxicity if overdosage occurs
Therapeutic Class
- Hepatic viral infections (Hepatitis B)
Storage Conditions
- Keep in a dry place
- Store below 30°C
- Protect from light
- Keep out of the reach of children