Entacavir 1.0 mg Tablet (Entacavir Hydrate)

Adult dose

Administer this medicine orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Administer entecavir 0.5mg orally once daily. Patients with lamivudine resistance, i.e., patients aged 16 years or older who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: Administer entecavir 1mg once daily on an empty stomach. Patients with renal failure: In patients with renal failure, the oral clearance of this medicine decreases as creatinine clearance decreases. Adjust the dose as follows in patients with creatinine clearance below 50mL/min, including patients receiving hemodialysis or continuous ambulatory 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 less than 0.5mg, use of the syrup formulation is recommended. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session. (Pharmacokinetic properties in patients with renal failure: See “8. Administration to patients with renal failure” under Precautions for Use.)

This drug may cause severe liver problems such as lactic acidosis and fatty liver in patients with impaired liver function, requiring caution. There is a risk of rapid worsening of hepatitis B if treatment is discontinued, so liver function should be continuously monitored after cessation. This drug is not recommended for patients infected with HIV who are not receiving treatment, and an HIV test is required before use. This drug should not be administered to patients allergic to this drug or its components, or to those with lactose intolerance. In renal impairment patients or those undergoing dialysis, dosage adjustments are necessary, and kidney function should be closely monitored in patients who have undergone liver transplantation. This medication may cause side effects such as headaches, fatigue, dizziness, and nausea; if symptoms worsen, consultation with a physician is necessary. It is best to take this drug on an empty stomach, as food may reduce drug absorption. This drug is primarily excreted through the kidneys, so careful monitoring for side effects is advised when used with other medications that affect kidney function. During pregnancy, it should only be used if absolutely necessary due to risks to the fetus, and if breastfeeding, nursing should be stopped or medication discontinued. It can be used in children aged 2 years and older; safety and efficacy in children under 2 years have not been established. Elderly patients may have elevated drug concentrations due to decreased kidney function, requiring dosage adjustments and monitoring of renal function. There is no specific antidote for overdose; appropriate treatment should be provided based on symptoms, and some drugs may be removed through dialysis. This drug should be stored in a tightly closed container, protected from light, and kept out of the reach of children.

• Lactic acidosis
• fatty liver
• acute liver enlargement
• impaired liver metabolic function
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

This drug should be stored in a tightly closed container to protect it from air and light, avoiding direct sunlight. It is recommended to maintain the storage temperature between 15 to 30 degrees.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP X 3)