Enteca 0.5 mg (Tablet)

Unit Price: ৳ 48.00 (1 x 10: ৳ 480.00)
Strip Price: ৳ 480.00

Medicine Details

Category Details
Generic Entecavir
Company Renata limited

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
  • Active viral replication
  • Persistent 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
  • Incorporated into the DNA upon activation by kinases

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 patients or those with known resistance mutations: 1 mg once daily
  • Recommended dose for patients with decompensated liver disease (adults): 1 mg once daily
  • Administered on an empty stomach
  • Missed Dose: Do not take a double dose

Interaction

  • No significant drug interactions with Lamivudine or Adefovir dipivoxil
  • Effects of co-administration with other drugs eliminated through renal or known to affect renal function have not been evaluated

Contraindications

  • 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 transmission of HBV from mother to infant
  • Precautions should be taken
  • Not known whether it is excreted in human milk
  • Mothers should be instructed not to breastfeed if taking Entecavir

Precautions & Warnings

  • Lactic acidosis reported with the use of nucleoside analogues alone or in combination with antiretrovirals
  • Exacerbations of hepatitis after discontinuation of treatment reported
  • Safety and effectiveness not established in pediatric patients below the age of 2 years
  • Care should be taken in dose selection for geriatric patients
  • Dose adjustment in renal impairment recommended

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 impaired renal function

Overdose Effects

  • No reported experience of Entecavir overdosage in patients
  • Healthy subjects who received high doses had no unexpected adverse events
  • Patients 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

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