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Entecavir STELLA 0.5 mg
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Entecavir STELLA 0.5 mg contains entecavir, a guanosine nucleoside analogue with activity against HBV polymerase, is used in treatment of chronic hepatitis B in adults.

Pack size Box of 30 tablets.
Shelf-life 24 months
Composition Entecavir
Dosage forms and strengths Film-coated tablet: 0.5 mg.
Product code :

PRESCRIBING INFORMATION

Indications:

Treatment of chronic hepatitis B in adults with compensated liver disease with evidence of active viral replication, persistently elevated liver enzyme values, and histologically active disease, including those resistant to lamivudine.

Dosage:

Adults and adolescents ≥ 16 years of age:

Patients with chronic hepatitis B virus infection in nucleoside-treatment-naive: 0.5 mg once daily.

Patients with a history of hepatitis B viremia while receiving lamivudine or known lamivudine resistance mutations: 1 mg once daily.

Patients with renal impairment:

  • ClCr ≥ 50mL/min: 0.5 mg once daily (Lamivudine-refractory: 1 mg once daily)
  • ClCr 30 – < 50mL/ min: 0.25 mg once daily (Lamivudine-refractory: 0.5 mg once daily)
  • ClCr 10 – < 30mL/ min: 0.15 mg once daily (Lamivudine-refractory: 0.3 mg once daily)
  • ClCr < 10mL/ min (Hemodialysis (administer after hemodialysis) or continuous ambulatory peritoneal dialysis (CAPD)): 0.05 mg once daily (lamivudine-refractory: 0.1 mg once daily).

Usage:

Entecavir STELLA 0.5 mg should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).

Patients with previously demonstrated hypersensitivity to any component of the product.

Headache, fatigue, dizziness, and nausea. Diarrhoea, dyspepsia, insomnia, somnolence, and vomiting. Raised liver enzyme concentrations may occur and exacerbation of hepatitis has been reported after stopping treatment with entecavir. Lactic acidosis, usually associated with severe hepatomegaly and steatosis.

  • Hepatic function should be monitored closely follow-up for at least several months in patients who discontinue anti-hepatitis B therapy.
  • Renal function must be carefully monitored both before and during treatment with entecavir in liver transplant recipients.
  • Entecavir should be used during pregnancy only if clearly needed and after careful consideration of the risks and benefits. Mothers should not to breast-feed if they are taking entecavir.
  • Patients should be aware of how they react to drug before driving or operating machinery.