Enviral 1 mg (Tablet)

Unit Price: ৳ 90.95 (1 x 14: ৳ 1,273.30)
Strip Price: ৳ 1,273.30

Medicine Details

Category Details
Generic Entecavir
Company Opsonin pharma ltd
Also available as
Enviral 05 mg tablet

Indications

  • Treatment of chronic hepatitis B virus infection in adults
  • 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 natural substrate deoxyguanosine triphosphate
  • Functionally 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 for nucleoside-treatment-naive adults and adolescents 16 years of age: 0.5 mg once daily
  • Recommended dose for Lamivudine-refractory or known Lamivudine or Telbivudine resistance mutations: 1 mg once daily
  • Recommended dose for patients with decompensated liver disease (adult): 1 mg once daily
  • Should be administered on an empty stomach
  • Missed Dose: If it is almost time for next dose, skip the missed dose and take the next dose at the proper time

Interaction

  • Co-administration with Lamivudine or Adefovir dipivoxil
  • Effects of co-administration with other drugs that are eliminated through renal or affect renal function

Contraindications

  • Patients with previously demonstrated hypersensitivity to Entecavir or any component of the product

Side Effects

  • Headache
  • Fatigue
  • Dizziness
  • Nausea

Pregnancy & Lactation

  • No data on the effect of Entecavir on the transmission of HBV from mother to infant
  • Not known whether it is excreted in human milk
  • Mothers should be instructed not to breastfeed if they are taking Entecavir

Precautions & Warnings

  • Lactic acidosis
  • Severe hepatomegaly with steatosis
  • Exacerbations of hepatitis after discontinuation of treatment
  • Severe acute exacerbations of hepatitis B after discontinuation of anti-hepatitis B therapy
  • Safety and effectiveness in pediatric patients below the age of 2 years not established
  • Care should be taken in dose selection for geriatric patients
  • Dose adjustment recommended for patients with renal impairment

Use in Special Populations

  • Safety and effectiveness in pediatric patients below the age of 2 years not established
  • Clinical studies did not include sufficient numbers of subjects aged 65 years and over
  • Dose adjustment recommended for patients with CrCl <50 ml/min

Overdose Effects

  • No experience of Enviral overdosage reported in patients
  • Healthy subjects who received up to 20 mg daily for up to 14 days had no unexpected adverse events
  • If overdosage occurs, the patient must be monitored for evidence of toxicity

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

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