Entazen Tablet 1mg (Entecavir)

Adult dose

Take this medicine orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Take 0.5mg of entecavir orally once daily. Patients with lamivudine resistance, i.e., patients 16 years of age and older who have experienced persistent hepatitis B virus replication despite lamivudine treatment or who have lamivudine-resistance mutations: 1mg of entecavir 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 those 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 once daily a 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 once daily a or 0.5 mg every 72 hours / Entecavir dose in patients with lamivudine resistance 0.3 mg once daily a or 1 mg every 72 hours Creatinine clearance (mL/min) <10, hemodialysis b or CAPD: Entecavir dose 0.05 mg once daily a or 0.5 mg every 7 days / Entecavir dose in patients with lamivudine resistance 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 characteristics in patients with renal failure: See “8. Administration to patients with renal failure” under Precautions for Use.)

This medication requires careful caution when used in patients with liver disease. Specifically, serious liver issues such as lactic acidosis and steatosis may occur in women and obese patients, so the medication should be discontinued if there is any abnormality in liver function. Abruptly stopping treatment for Hepatitis B can lead to rapid deterioration of liver function, so caution should be exercised in consultation with a physician when discontinuing treatment, and liver status should be continuously monitored. This medication is not recommended for patients co-infected with HIV and Hepatitis B who are not receiving HIV treatment, and a test for HIV infection must be conducted before treatment. Patients allergic to this medication or its components should not take it, and those with specific genetic metabolic abnormalities such as lactose intolerance should also avoid taking it. Patients with impaired kidney function or those undergoing dialysis should have their dosage adjusted, and those who have undergone liver transplantation should monitor kidney and liver functions carefully while taking this medication. Taking this medication on an empty stomach may enhance absorption, so taking it with food may reduce its effectiveness. Long-term use may result in side effects such as headache, fatigue, dizziness, nausea, and regular liver function and other clinical tests are necessary. Pregnant or breastfeeding women should consult a doctor before taking this medication, as its effects on the fetus or newborn are not clear. Use in children is recommended only for those aged 2 and older; safety and efficacy have not been established for children under 2 years old. In case of an overdose, there are no specific antidotes, so symptoms should be closely monitored and supportive treatment should be received as necessary. This medication should be stored out of reach of children, protected from direct sunlight, and kept at room temperature. Additionally, transferring to other containers may lead to degradation of quality, so caution is necessary.

• Hyperechoic liver
• fatty liver
• hepatomegaly
• hepatic metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• indigestion

This medication should be stored in a tightly sealed container to avoid air or moisture exposure, with a storage temperature maintained between 15 and 30 degrees Celsius. This helps in maintaining the effectiveness of the medication.

Appearance

Pink triangular film-coated tablet

Package unit

- - 30 tablets/PTP [10 tablets/PTP × 3]