Entakim Tablet 0.5 mg (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 this drug orally once daily at a dose of 0.5mg of entecavir. Patients aged 16 years and 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: 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. Adjust the dose as follows in patients with creatinine clearance less than 50mL/min, including patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Creatinine clearance (mL/min) ≥ 50: Entecavir dose 0.5 mg once daily; Entecavir dose in patients with lamivudine resistance 1 mg once daily Creatinine clearance (mL/min) 30 - <50: Entecavir dose 0.25 mg a once daily or 0.5 mg every 48 hours; Entecavir dose in patients with lamivudine resistance 0.5 mg once daily or 1 mg every 48 hours Creatinine clearance (mL/min) 10 - <30: Entecavir dose 0.15 mg a once daily or 0.5 mg every 72 hours; Entecavir dose in patients with lamivudine resistance 0.3 mg a once daily or 1 mg every 72 hours Creatinine clearance (mL/min) <10, hemodialysis b or CAPD: Entecavir dose 0.05 mg a once daily or 0.5 mg every 7 days; Entecavir dose in patients with lamivudine resistance 0.1 mg a once daily or 1 mg every 7 days a : Use of the syrup formulation is recommended for doses less than 0.5mg. b : If administered on a hemodialysis day, administer this drug after the hemodialysis session. (Pharmacokinetic properties in patients with renal failure: See “8. Administration to Patients with Renal Failure” under Precautions for Use)

Child dose

There are no specified dosage guidelines for children.

This medication requires special caution when administered to patients with liver function problems. There is a risk of severe liver enlargement accompanying lactic acidosis and steatosis particularly in female patients when using nucleoside analog drugs. Additionally, abruptly discontinuing this medication may lead to a rapid deterioration of hepatitis B, thus liver function tests must be closely monitored for several months after stopping the treatment. It is not recommended for patients co-infected with HIV and hepatitis B who are not receiving HIV treatment, and HIV infection status must be confirmed prior to therapy. This medication should not be administered to patients with hypersensitivity to its components or those with certain genetic lactose intolerance disorders. Dose adjustments are necessary for patients with impaired renal function, especially those undergoing hemodialysis or peritoneal dialysis, and liver transplant recipients should also have their renal function monitored closely. During treatment, side effects such as headaches, fatigue, dizziness, nausea, etc., may occur, and treatment should be stopped immediately if liver function test results worsen or signs of lactic acidosis appear. Taking this medication with food may decrease drug absorption; therefore, it is better to take it on an empty stomach. Since this drug is excreted through the kidneys, careful observation for side effects is necessary when taken with other medications that may affect renal function. During pregnancy, it should only be used when absolutely necessary due to potential risks to the fetus, and breastfeeding women are advised to either stop breastfeeding or discontinue the medication due to the possibility of the drug being excreted in breast milk. Use in children is permitted only for those aged 2 years and older, and safety and efficacy for those younger than 2 years have not been confirmed. Elderly patients are at a higher risk for decreased renal function, thus dose adjustments and monitoring of renal function are necessary. In cases of overdose, there is no specific antidote, so the patient's condition should be monitored closely, and supportive therapy should be provided as needed. Finally, this medication should be stored out of the reach of children, protected from direct sunlight, and kept at room temperature. For syrup formulations, use should be limited to within the expiration period after opening, and it is safe not to mix with other solvents.

• Lactic acidosis
• fatty liver
• liver enlargement
• liver metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• indigestion

This medication should be stored in an airtight container to prevent air exposure, and the optimal storage temperature is between 15 to 30 degrees Celsius. Proper storage helps maintain the drug's efficacy and prevents degradation.

Appearance

White to grayish-white triangular film-coated tablet

Package unit

Export - 30 tablets/PTP [30 tablets (10 tablets/Alu-Alu PTP X 3)], Export - 120 tablets/PTP [12 tablets (10 tablets/Alu-Alu PTP X 12)], Export - 500 tablets/PTP [500 tablets (10 tablets/Alu-Alu PTP X 50)], Export - 1000 tablets/PTP [1000 tablets (10 tablets/Alu-Alu PTP X 100)], Domestic - 30 tablets/PTP [30 tablets (10 tablets/Alu-Alu