Baralivir Tablets 0.5 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.

This medication is used for the treatment of liver diseases, and there are several important precautions to consider. First, serious liver-related side effects such as lactic acidosis and steatosis may occur if this medication is used alone or in combination with other antiretroviral drugs, so liver health should be closely monitored. Second, sudden discontinuation of treatment may worsen hepatitis B, so liver function should be checked regularly according to a physician's instructions when stopping treatment. Third, this medication is not recommended for patients with HIV infection, and an HIV test must be conducted before administration. Fourth, this medication should not be administered to patients with allergies to this drug or its components and to certain genetically lactose-intolerant patients. Fifth, dosage adjustment is necessary for patients with impaired kidney function or those undergoing hemodialysis, and patients who have undergone liver transplantation should closely monitor kidney function. Sixth, side effects such as headache, fatigue, dizziness, and nausea may occur, and if abnormal liver function test results appear, immediate consultation with a physician is required. Seventh, taking this medication with food can decrease absorption, so it is advisable to take it on an empty stomach. Eighth, during pregnancy, this medication should only be used when absolutely necessary, taking fetal risk into account, and during breastfeeding, either breastfeeding should be discontinued or medication use should be stopped. Ninth, since this medication is mainly excreted through the kidneys, elderly patients with poor kidney function or patients with renal failure need dosage adjustment and kidney function monitoring. Finally, this medication should be kept out of reach of children and stored according to specified temperature and method.

• Hyperlipidemia
• steatosis
• severe hepatic enlargement
• liver metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. Additionally, it is important to store it at room temperature between 15 to 30 degrees Celsius to maintain efficacy.

Appearance

White to grayish-white triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP X 3)