Entecavir Stella 0.5mg (3 blisters x 10 tablets/box)

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.

---

Contraindications

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

---

Compositon/Ingredients

Entecavir 0.5mg

---

Dosage and administration

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).

---

Precaution

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.

---

Storage

Store at temperature below 30°C, protect from light.