Entacavir Tablet 0.5 mg (Entacavir Hydrate)

Adult dose

Administer this medicine orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Administer entecavir 0.5mg orally once daily. Patients with lamivudine resistance, i.e., patients aged 16 years or older who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: Administer entecavir 1mg 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 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 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 properties in patients with renal failure: See “8. Administration to patients with renal failure” under Precautions for Use.)

This medication may cause serious side effects, such as lactic acidosis and fatty liver, when administered to patients with liver disease, so caution is advised. These side effects have been reported more frequently in women, as well as in patients who are obese or have used nucleoside analogs for a prolonged period. Patients with impaired liver function are at higher risk for lactic acidosis; if liver function test results show abnormalities during the use of this medication, treatment should be immediately stopped. Abrupt discontinuation of this medication may lead to a rapid deterioration of hepatitis B, so liver function should be closely monitored for several months after discontinuation. The use of this medication is not recommended for patients who are HIV-infected but not receiving treatment, and HIV infection status should be checked before use. This medication should not be administered to patients with allergies to it or its components, or with hereditary lactose intolerance. Dose adjustments are needed for patients with impaired kidney function or those undergoing dialysis, and kidney function should be carefully monitored in liver transplant recipients. Side effects such as headache, fatigue, dizziness, nausea, and changes in liver function test values may occur, and these should be periodically monitored. Taking this medication with food may decrease its absorption, so it is best to take it on an empty stomach. Since it is primarily excreted by the kidneys, attention should be paid to possible side effects when used with other medications affecting kidney function. The risks and benefits to the fetus should be carefully considered during pregnancy, and if nursing, it is recommended to either discontinue breastfeeding or discontinue the medication. The safety and efficacy have only been confirmed in pediatric patients aged 2 years and older, and elderly patients may need dose adjustments and monitoring due to decreased kidney function. There is no specific antidote for overdose, and supportive treatment should be administered according to symptoms; some can be removed by hemodialysis. This medication should be kept out of reach of children, stored in a tightly sealed container away from direct sunlight, and kept at room temperature.

• Lactic acidosis
• steatosis
• liver hypertrophy
• liver metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

This medication should be stored in a tightly sealed container to prevent exposure to air and light. Additionally, it is advisable to keep it at a temperature between 15 degrees and 30 degrees Celsius, avoiding excessively hot or cold places.

Appearance

White, triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP X 3)