Encaron Tablet 0.5 mg (Entacavir)

Adult dose

Administer this drug orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Administer this drug orally once daily at a dose of 0.5mg of entecavir. Patients aged 16 years and older with lamivudine resistance, that is, patients who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: 1mg of entecavir once daily on an empty stomach Patients with renal failure: In patients with renal failure, the oral clearance of this drug decreases as creatinine clearance decreases. For patients with creatinine clearance below 50mL/min, including those receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), adjust the dose as follows. 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 0.5mg, use of the syrup formulation is recommended. b: If administered on a hemodialysis day, administer this drug after the hemodialysis session.

Child dose

Limited to lamivudine-resistant patients aged 16 years and older: Take 1 mg of entacavir orally once daily on an empty stomach.

This drug may cause serious liver problems, such as lactic acidosis and steatosis, particularly in women with severe liver disease, so caution is necessary. Patients with impaired liver function are at increased risk of lactic acidosis while using this drug, and if any abnormalities are found in liver function tests, drug use should be temporarily suspended. Sudden discontinuation of this drug may lead to a rapid deterioration of hepatitis B, so liver function should be closely monitored for several months after discontinuation. For patients co-infected with HIV and hepatitis B who are not undergoing HIV treatment, the use of this drug is not recommended, and testing for HIV infection is necessary. Patients with allergies to this drug or its ingredients, or any specific genetic metabolic disorders such as lactose intolerance, should not receive this medication. Patients with impaired renal function, especially those undergoing hemodialysis or peritoneal dialysis, require dose adjustment and close monitoring of renal function. Patients who have received a liver transplant should closely evaluate and observe renal function when co-administering other medications that may affect renal function. During the use of this drug, side effects such as headache, fatigue, dizziness, nausea, and others may occur, and abnormalities in liver function tests may arise, so regular testing is recommended. The risk of hepatitis worsening when treatment is discontinued necessitates careful management according to healthcare provider instructions. This drug is most effective when taken on an empty stomach, as food may reduce its absorption. Since it is primarily excreted through the kidneys, caution is needed when co-administering other medications that may affect renal function, as drug concentrations may change and side effects may arise. During pregnancy, it should only be used when necessary due to potential risks to the fetus, and during breastfeeding, it is recommended to either discontinue breastfeeding or stop the medication. Safety and efficacy have only been confirmed in patients aged 2 years and older, and its use is not recommended in those under 2 years. Elderly patients may have a higher likelihood of decreased renal function, requiring dose adjustment and monitoring of renal function. In cases of overdose, as there is no specific antidote, supportive treatment according to symptoms should be implemented, and some removal may be achieved via hemodialysis. This drug should be stored out of the reach of children, away from direct sunlight, and at room temperature.

• lactic acidosis
• steatosis
• severe liver enlargement
• liver metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• indigestion

This drug should be stored in an airtight sealed container, preferably at room temperature between 15 degrees and 30 degrees. Proper storage helps maintain the drug's efficacy.

Appearance

White to pale gray triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP*3)