Baraclude Tablet 1 mg (Entecavir)

Adult dose

This medication should be administered orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Recommended dosage for adults (16 years and older) This medication should be administered orally once daily at a dose of 0.5 mg of entecavir. Patients with lamivudine resistance, i.e., patients 16 years and older who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: 1 mg of entecavir orally once daily on an empty stomach Patients with renal impairment In adults with renal impairment, the oral clearance of this medication decreases as creatinine clearance decreases. The dosage should be adjusted as shown in Table 2 for adult patients with creatinine clearance less than 50 mL/min, including patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Creatinine clearance (mL/min) ≥ 50: Entecavir dosage 0.5 mg once daily; entecavir dosage for patients with lamivudine resistance 1 mg once daily Creatinine clearance (mL/min) 30 - <50: Entecavir dosage 0.25 mg once daily a or 0.5 mg every 48 hours; entecavir dosage for patients with lamivudine resistance 0.5 mg once daily or 1 mg every 48 hours Creatinine clearance (mL/min) 10 - <30: Entecavir dosage 0.15 mg once daily a or 0.5 mg every 72 hours; entecavir dosage 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 dosage 0.05 mg once daily a or 0.5 mg every 7 days; entecavir dosage for patients with lamivudine resistance 0.1 mg once daily a or 1 mg every 7 days a : Use of the oral solution is recommended for doses less than 0.5 mg. b : If administered on a hemodialysis day, this medication should be administered after the hemodialysis session.

Child dose

Recommended dosage for pediatric patients Table 1 shows the recommended dosage of this drug for pediatric patients aged 2 years or older and weighing at least 10kg. The syrup should be used only in patients weighing up to 30kg. 10 to 11 kg: Recommended once-daily dose of syrup 3 mL Over 11 to 14 kg: Recommended once-daily dose of syrup 4 mL Over 14 to 17 kg: Recommended once-daily dose of syrup 5 mL Over 17 to 20 kg: Recommended once-daily dose of syrup 6 mL Over 20 to 23 kg: Recommended once-daily dose of syrup 7 mL Over 23 to 26 kg: Recommended once-daily dose of syrup 8 mL Over 26 to 30 kg: Recommended once-daily dose of syrup 9 mL Over 30 kg: Recommended once-daily dose of syrup 10 mL a Children weighing over 30kg should receive 10 mL of syrup or one 0.5 mg tablet once daily. There are insufficient data to recommend a specific dosage adjustment for this drug in pediatric patients with renal impairment. However, as with dosage adjustments in adults, reducing the dose or increasing the dosing interval should be considered.

This medication should be used with caution in patients with liver disease, especially in women or obese patients, as serious liver issues such as lactic acidosis and steatosis may occur. If symptoms of lactic acidosis or liver dysfunction appear while using this medication, it should be discontinued immediately. Abrupt cessation of this medication may lead to rapid worsening of hepatitis B, so liver function should be closely monitored for several months after discontinuation. This medication is not recommended as monotherapy for patients who are HIV-infected and not receiving treatment; an HIV test should be done first. This medication should not be administered to patients with known allergies to it or its components, or with genetic problems such as lactose intolerance. Patients with renal impairment or those undergoing dialysis need dosage adjustment, and patients who have undergone liver transplantation should have their kidney function closely monitored. Side effects such as headache, fatigue, dizziness, nausea may occur, and if abnormal liver function test results are found, the physician should be consulted regarding the continuation of treatment. Taking this medication with food may reduce absorption, so it is advisable to take it on an empty stomach. During pregnancy, the risks to the fetus should be considered, and it should only be used when absolutely necessary; breastfeeding should either be discontinued or the medication should be stopped during lactation. Since this medication is excreted through the kidneys, dosage adjustments are necessary for patients with renal function impairment, and patients on dialysis should take it after the dialysis procedure. Elderly patients may have increased drug levels due to decreased renal function, requiring careful dosage adjustment and monitoring of renal function. In the case of overdose, no specific antidote exists, so appropriate treatment and observation based on symptoms are necessary. This medication should be stored out of reach of children, in a tightly closed container at room temperature, and syrup forms should be used only within their expiration date after opening.

• Lactic acidosis
• steatosis
• hepatomegaly
• hepatic metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. The appropriate storage temperature is room temperature between 15 to 30 degrees, avoiding excessively hot or cold locations.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets/PTP