Solid Tablet (Entecavir)

Adult dose

Administer this drug orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Administer 0.5 mg of entecavir orally once daily. Patients aged 16 years or older with lamivudine resistance, i.e., patients who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: 1 mg of entecavir once daily on an empty stomach Patients with renal impairment: In patients with renal impairment, the oral clearance of this drug decreases as creatinine clearance decreases. Adjust the dose as follows in patients with creatinine clearance below 50 mL/min, including patients receiving hemodialysis or peritoneal dialysis (CAPD). Creatinine clearance (mL/min) Entecavir dose Entecavir dose in patients with lamivudine resistance ≥ 50 0.5 mg once daily 1 mg once daily 30 - <50 0.25 mg once daily a or 0.5 mg every 48 hours 0.5 mg once daily or 1 mg every 48 hours 10 - <30 0.15 mg once daily a or 0.5 mg every 72 hours 0.3 mg once daily a or 1 mg every 72 hours <10, hemodialysis b or CAPD 0.05 mg once daily a or 0.5 mg every 7 days 0.1 mg once daily a or 1 mg every 7 days a: For doses below 0.5 mg, use of the oral solution is recommended. b: If administered on a hemodialysis day, administer this drug after the hemodialysis session. (Pharmacokinetic properties in patients with renal impairment: See “8. Administration to patients with renal impairment” under Precautions for Use)

This drug is mainly used to treat chronic hepatitis B, and special caution is needed for patients with liver dysfunction or renal impairment. When using this drug, there is a risk of serious liver diseases such as lactic acidosis and fatty liver, so liver function tests and clinical conditions should be monitored periodically. If treatment is suddenly stopped, hepatitis B may dramatically deteriorate, so it should be managed carefully according to the doctor's instructions when discontinuing. It is recommended not to use this drug in HIV-infected patients who are not receiving antiretroviral therapy. This drug contains lactose; therefore, patients with lactose intolerance or related genetic diseases should not take it. In patients with renal failure or those undergoing hemodialysis, the dosage of this drug should be adjusted, and liver transplant recipients should also administer the drug while closely monitoring kidney function. This drug may cause side effects such as headache, fatigue, dizziness, and nausea; if symptoms worsen, consult a doctor. Taking it with food may reduce drug absorption, so it is better to take it on an empty stomach. During pregnancy, its use should be limited to cases where it is essential, considering the risk to the fetus, and during breastfeeding, it is preferable to discontinue breastfeeding or the medication. There is no specific antidote for overdose, and appropriate supportive treatment should be received according to symptoms. This drug should be stored in a sealed container away from the reach of children, avoiding direct sunlight and stored at room temperature.

• Lactic acidosis
• steatosis
• hepatomegaly
• hepatic metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

This drug should be stored in a sealed container to avoid exposure to air or humidity. It is also recommended to keep it at room temperature between 15 and 30 degrees Celsius, avoiding extremes of temperature.

Appearance

White to off-white triangular film-coated tablet

Package unit

30 tablets (10 tablets/ PTP * 3)