Enterone Tablet 0.5mg (Entecavir)

Adult dose

This medicine should be administered 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 and 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 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 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 is used for the treatment of hepatitis B virus infection and should be used with caution in patients with impaired liver function or reduced kidney function. During the course of this medication, regular liver function tests and blood tests should be conducted, and there is a possibility that hepatitis may worsen during or after treatment, so continuous monitoring as per healthcare provider's instructions is necessary. Women who are pregnant or breastfeeding should carefully assess the effects on the fetus or infant before using this medication, and if breastfeeding, it is recommended to either stop breastfeeding or discontinue the drug administration. This medication contains lactose, so patients with lactose intolerance should avoid it, and patients who are allergic to the drug should also refrain from using it. Patients with renal failure, especially those on hemodialysis or peritoneal dialysis, require dose adjustment, and patients who have undergone liver transplantation need careful monitoring of kidney function and drug interactions. It is advisable not to administer this medication to patients who are co-infected with HIV and hepatitis B when they are not receiving HIV treatment, and testing for HIV infection is necessary. Taking this medication with food may reduce drug absorption, so it is effective to take it on an empty stomach. In case of overdose, there is no specific antidote, so appropriate supportive care is needed based on symptoms, and some drugs may be removed by hemodialysis. This medication can lead to resistance if taken for a prolonged period, thus it is important to discuss and follow the treatment plan with healthcare providers. Side effects may include headache, fatigue, dizziness, dyspepsia, vomiting, etc., and rarely there may be indications of liver dysfunction, lactic acidosis, hair loss, and rash. If any unusual symptoms occur, it is crucial to inform healthcare providers immediately. This medication can be used in children and the elderly, but dose and kidney function adjustments are necessary, and particular caution is needed for the elderly who are at higher risk of adverse effects due to decreased kidney function. When storing, it should be kept in a cool place away from direct sunlight and out of reach of children, and syrup formulations must be used within the expiration date after opening. During the course of this medication, attention should be paid to sexual contact or blood exposure to prevent the transmission of hepatitis B, as taking medication alone does not entirely reduce transmission risk, safe practices are necessary.

• Lactic acidosis
• fatty liver
• hepatomegaly
• liver metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• indigestion

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is advisable to store it at room temperature between 15 to 30 degrees Celsius to maintain its efficacy.

Appearance

White to grayish white triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)