Baraliver Tablet 1.0 mg (Entecavir)

Adult dose

Take this medicine orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). The usual dose of entecavir is 0.5mg orally once daily. Patients with lamivudine resistance, i.e., patients 16 years of age or older who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: 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. 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 0.5mg once daily / entecavir dose for patients with lamivudine resistance 1mg once daily Creatinine clearance (mL/min) 30 - <50: entecavir dose 0.25mg a once daily or 0.5mg every 48 hours / entecavir dose for patients with lamivudine resistance 0.5mg once daily or 1mg every 48 hours Creatinine clearance (mL/min) 10 - <30: entecavir dose 0.15mg a once daily or 0.5mg every 72 hours / entecavir dose for patients with lamivudine resistance 0.3mg a once daily or 1mg every 72 hours Creatinine clearance (mL/min) <10, hemodialysis b or CAPD: entecavir dose 0.05mg a once daily or 0.5mg every 7 days / entecavir dose for patients with lamivudine resistance 0.1mg a once daily or 1mg 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.

Child dose

Patients aged 16 years and older with lamivudine-resistant hepatitis are treated as adults and should take 1 mg once daily on an empty stomach.

This drug should be used with caution in patients with weakened liver function or those at risk of liver disease, as serious side effects such as lactic acidosis and hepatic steatosis may occur. Abrupt discontinuation of this medication can severely worsen hepatitis B; therefore, close monitoring of liver function is necessary upon discontinuation, following a doctor's instructions. For patients co-infected with HIV and hepatitis B who are not receiving HIV treatment, using this medication may lead to resistance to HIV treatment, necessitating an HIV test before use. Patients with allergies to this medication or its components, or with genetic issues such as lactose intolerance, should not take this medication. Patients with impaired kidney function or those undergoing dialysis require dosage adjustment, and liver transplant recipients should carefully monitor kidney function. This medication is best taken on an empty stomach as taking it with food may reduce its effectiveness. Long-term use may result in side effects such as headache, fatigue, dizziness, nausea, and it is advisable to consult a doctor if abnormal symptoms occur. Pregnant women should only use this medication if necessary, considering the risks to the fetus, and breastfeeding mothers are advised to either stop breastfeeding or discontinue this medication. Use in children is permitted only for those aged 2 years and older; safety and efficacy have not been established in those under 2 years old. This medication is excreted through the kidneys, so patients with decreased kidney function may experience increased drug concentration, warranting caution. In case of overdose, there is no specific antidote, and appropriate treatment should be administered based on symptoms. It may be partially removed through dialysis. The risk of carcinogenicity was observed in animal studies, but the risk in humans is unclear, necessitating periodic checks under a doctor's supervision during prolonged use. Store out of reach of children, keep in a cool place away from direct sunlight, and do not transfer to another container.

Liver dysfunction, fatty liver, hepatomegaly, metabolic liver disease, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, vertigo, drowsiness, insomnia, anaphylactic reaction, increased aminotransferases, hair loss, rash, upper abdominal pain, chest burning, itching, cold, cough, chest pain, constipation, abdominal pain, lower back pain, abdominal discomfort, runny nose, intraperitoneal bleeding, ascites, portal hypertension-related gastric disease, gastrointestinal hemorrhage, cholangitis, hepatic encephalopathy, deviated septum, sepsis, eyelid skin disease, gastric hemangioma, chronic sinusitis, abdominal pain, rash, bad taste, neutropenia

This medication should be stored in a tightly sealed container to prevent air and moisture ingress, and it is best kept in a cool place at a temperature between 15 and 30 degrees Celsius. Storing it this way helps maintain the medication's efficacy over time and prevents degradation.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP X 3)