Baraclude Tablet 0.5 mg (Entacavir)

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 aged 16 years and older who are lamivudine-refractory, that is, 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 impairment: In patients with renal impairment, the oral clearance of this medicine decreases as creatinine clearance decreases. Adjust the dose as follows in patients with a creatinine clearance of less than 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 lamivudine-refractory patients 1 mg once daily Creatinine clearance (mL/min) 30 - <50: Entecavir dose 0.25 mg a once daily or 0.5 mg every 48 hours; entecavir dose in lamivudine-refractory patients 0.5 mg once daily or 1 mg every 48 hours Creatinine clearance (mL/min) 10 - <30: Entecavir dose 0.15 mg a once daily or 0.5 mg every 72 hours; entecavir dose in lamivudine-refractory patients 0.3 mg a once daily or 1 mg every 72 hours Creatinine clearance (mL/min) <10, hemodialysis b or CAPD: Entecavir dose 0.05 mg a once daily or 0.5 mg every 7 days; entecavir dose in lamivudine-refractory patients 0.1 mg a once daily 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.

Child dose

Dosage is specified for patients 16 years and older, but there are no specific guidelines mentioned for children under 16 years.

This medication requires special caution regarding liver health. Serious hepatic issues such as lactic acidosis and steatosis may occur during use, so particular caution is needed in patients with compromised liver function or at risk of liver disease. Abrupt discontinuation of this medication may result in severe exacerbation of hepatitis B, thus close monitoring of liver function is essential when stopping treatment as per the physician's guidance. The use of this medication is not recommended for patients co-infected with HIV and hepatitis B who are not receiving HIV treatment, and testing for HIV infection is required before use. Patients allergic to this medication or its components, and those with specific genetic metabolic disorders, such as lactose intolerance, should not take this medication. Patients with decreased renal function or those undergoing dialysis require dosage adjustments, and kidney function must be closely monitored in liver transplant recipients. Side effects like headache, fatigue, dizziness, nausea may occur during treatment, and if liver function test results worsen, treatment may need to be temporarily halted. To enhance absorption, this medication is best taken on an empty stomach. When used with other medications that affect renal function, careful monitoring for potential side effects is necessary. During pregnancy, it should only be used when necessary, considering the risk to the fetus, and during breastfeeding, it is recommended to discontinue either breastfeeding or the medication. Children and elderly patients also require careful dosage adjustments based on renal function. In case of overdose, as there is no specific antidote, symptoms should be observed and appropriate treatment pursued, as some of the medication may be removed through dialysis. This medication should be stored out of the reach of children, kept away from direct sunlight, and stored at room temperature. It is crucial to strictly follow the physician's instructions and regularly undergo liver and kidney function tests during treatment.

• Lactic acidosis
• fatty liver
• hepatic enlargement
• liver metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

This medication should be stored in a tightly sealed container to prevent air exposure and at room temperature between 15°C and 30°C. This helps maintain the efficacy of the medication and prevents degradation.

Appearance

White to grayish-white triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP) x 3