Entakim Tablet 1 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

No specific dosage is mentioned for patients under 16 years old, including those resistant to lamivudine; thus, pediatric dosage is not clearly defined.

This medication should be used with caution in patients with liver disease, especially in women, as serious liver enlargement, including lactic acidosis and steatosis, may occur. In patients with impaired liver function, the risk of lactic acidosis may increase during the use of this medication, so if abnormalities appear in liver function test results, administration should be temporarily halted. Discontinuation of treatment may lead to acute exacerbation of hepatitis B; therefore, liver function and virus status should be closely monitored for several months after treatment ends. In patients with concurrent HIV and hepatitis B infection who are not receiving HIV treatment, the use of this medication is not recommended, and an HIV test is required prior to use. Patients with allergies to this medication or its components, or those with genetic problems such as lactose intolerance, should not take this medication. Patients with renal insufficiency, especially those on hemodialysis or peritoneal dialysis, may require dose adjustments, and kidney function should be closely monitored in patients who have undergone liver transplant. Caution should be observed in administering this medication if there is an allergy to the dyes included in this medication. This medication may cause side effects such as headache, fatigue, dizziness, nausea, and liver function test levels may increase, so regular testing is necessary. Hepatitis may worsen after discontinuation of treatment; thus, liver function status must be carefully monitored during treatment cessation. This medication is excreted through the kidneys, so caution is necessary concerning the possibility of side effects when used in patients with impaired kidney function and with drugs affecting renal excretion. During pregnancy, this medication should only be used if absolutely necessary considering the risks to the fetus, and in nursing mothers, consideration should be given to either discontinuing nursing or the medication. Taking this medication with food may decrease its absorption; thus, it is recommended to take it on an empty stomach. Elderly patients may have increased drug concentrations due to decreased renal function; therefore, dose adjustments and monitoring of kidney function are needed. In case of overdose, consult medical personnel immediately and receive appropriate supportive care if necessary. This medication should be kept out of reach of children, stored in a tightly sealed container at room temperature, and not transferred to other containers.

• Hyperlipidemia
• fatty liver
• hepatic enlargement
• impaired liver metabolism
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

This medication should be stored in a tightly sealed container to prevent air and moisture exposure, in a cool place between 15 and 30 degrees Celsius. Storing in this manner will help maintain the medication's effectiveness for a longer period.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets (10 tablets/1 PTP X 3)