Entavir 0.5 mg (Entecavir)

Adult dose

This medicine should be taken orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). The usual dose is 0.5mg of entecavir orally once daily. Patients with lamivudine resistance, i.e., patients aged 16 years and older 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 impairment: In patients with renal impairment, the oral clearance of this medicine decreases as creatinine clearance decreases. For patients with creatinine clearance below 50mL/min, including those receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), adjust the dose as follows. Creatinine clearance (mL/min) ≥ 50: entecavir dose 0.5 mg once daily / entecavir dose for 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 for 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 for 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 for patients with lamivudine resistance 0.1 mg once daily a 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” in Precautions for Use)

Child dose

Limited to patients aged 16 years and older with lamivudine-resistant hepatitis B virus that has persisted despite lamivudine therapy or who have lamivudine-resistant mutations.

This medication requires caution when used in patients with severely impaired liver function or decreased renal function. In particular, dosage adjustment is recommended for patients with renal failure or those undergoing hemodialysis. Additionally, abruptly stopping this medication may lead to rapid deterioration of hepatitis B; therefore, regular liver function tests must be conducted as per the physician's instructions upon discontinuation of treatment. This medication should be administered cautiously in pregnant women considering potential risks to the fetus, and nursing mothers should consider discontinuing breastfeeding or consult a physician. This medication can interact with other drugs, so it is important to inform the physician if taking medications that affect renal function. Taking this medication with food may reduce absorption; thus, it is best taken on an empty stomach. Serious side effects such as potentially fatal lactic acidosis, steatosis, or hepatomegaly have been reported; if such symptoms occur, immediate medical consultation is necessary. This medication is not recommended for HIV-infected individuals who are not receiving treatment for HIV, and an HIV test is required before administration. Patients with hypersensitivity to this medication or genetic issues such as lactose intolerance should not take it. During treatment, side effects such as headache, fatigue, dizziness, nausea, and others may occur; if unusual symptoms persist, consult the medical staff.

• Urticaria
• liver metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia
• vomiting
• vertigo

This medication should be stored in a tightly sealed container to protect it from air and light exposure. Additionally, it should be kept away from direct sunlight and stored in a cool place between 15 to 30 degrees Celsius.

Appearance

White triangular film-coated tablet

Package unit

30 tablets