Enbir Tablet 0.5 mg (Entecavir)

Adult dose

Administer this medicine orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Administer 0.5mg of entecavir orally once daily. Patients 16 years of age and older with lamivudine resistance, that is, patients who 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 impairment: In patients with renal impairment, 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) ≥ 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: For doses below 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 impairment: See “8. Administration to patients with renal impairment” under Precautions for Use.)

Special care is needed when administering this medication to patients with liver disease. Severe adverse effects such as lactic acidosis and steatosis may occur, especially in cases of severely impaired liver function, so the drug should be stopped immediately if symptoms of liver dysfunction appear. Additionally, stopping this medication may lead to a rapid worsening of hepatitis B, so liver function and clinical status should be carefully monitored for several months after discontinuation. This medication is not recommended for patients receiving treatment for HIV infection, and it is safer to administer after confirming HIV infection status. Patients with allergic reactions or hypersensitivity to any components of this drug should not use it, and those with certain genetic disorders such as lactose intolerance should also avoid this medication. Patients with reduced kidney function, particularly those undergoing hemodialysis or peritoneal dialysis, require dosage adjustments, and liver transplant patients should carefully monitor their kidney function. The most common side effects of this drug include headaches, fatigue, dizziness, nausea, among others, and liver function tests may show elevated levels, so regular liver function tests are necessary. During pregnancy, the risks and benefits to the fetus should be carefully considered before administration, and during breastfeeding, since the drug may be excreted in breast milk, it is recommended to either discontinue breastfeeding or stop the medication. This drug's absorption decreases when taken with food, so it is recommended to take it on an empty stomach. Additionally, since renal excretion is the main route, caution should be exercised when using it with other medications that affect kidney function, due to the possibility of adverse effects. In case of overdose, patients should be closely monitored, and if necessary, appropriate supportive treatment should be administered; some of the drug can be removed through hemodialysis. This medication's safety and effectiveness may vary in specific populations such as children, the elderly, and pregnant women, so special caution is needed. Lastly, this drug should be kept out of reach of children, stored away from direct sunlight and at room temperature.

• Lactic acidosis
• fatty liver
• hepatic enlargement
• impaired liver metabolism
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• indigestion

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is best kept in a cool place between 15 and 30 degrees Celsius.

Appearance

White to grayish-white triangular film-coated tablet

Package unit

30 tablets (10 tablets/AluAlu packaging x 3)