Baraclude 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). Recommended dosage for adults (16 years and older) The recommended dose of this medicine is 0.5mg of entecavir 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: 1mg of entecavir orally once daily on an empty stomach In adults with renal impairment, the oral clearance of this medicine decreases as creatinine clearance decreases. For adult patients with creatinine clearance below 50mL/min, including patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), adjust the dosage as shown in Table 2. ≥ 50 mL/min: 0.5 mg once daily; entecavir dosage for patients with lamivudine resistance 1 mg once daily 30 - <50 mL/min: 0.25 mg a once daily 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 10 - <30 mL/min: 0.15 mg a once daily or 0.5 mg every 72 hours; entecavir dosage for patients with lamivudine resistance 0.3 mg a once daily or 1 mg every 72 hours <10, hemodialysis b or CAPD: 0.05 mg a once daily or 0.5 mg every 7 days; entecavir dosage for patients with lamivudine resistance 0.1 mg a once daily or 1 mg every 7 days a : Use of the oral solution is recommended for doses below 0.5mg. b : If administered on a hemodialysis day, administer this medicine after the hemodialysis session.

Child dose

Pediatric patients aged 2 years or older and weighing at least 10 kg Use the syrup formulation only in patients weighing up to 30 kg. 10 to 11 kg: 3 mL of syrup once daily Over 11 to 14 kg: 4 mL of syrup once daily Over 14 to 17 kg: 5 mL of syrup once daily Over 17 to 20 kg: 6 mL of syrup once daily Over 20 to 23 kg: 7 mL of syrup once daily Over 23 to 26 kg: 8 mL of syrup once daily Over 26 to 30 kg: 9 mL of syrup once daily Over 30 kg: Administer 10 mL of syrup once daily or one 0.5 mg tablet once daily. Although there are insufficient data to recommend a definitive dosage adjustment for pediatric patients with renal impairment, reducing the dose or extending the dosing interval should be considered, similarly to dosage adjustments in adults.

This medicine is used for the treatment of liver diseases, and liver health status should be carefully monitored. Particularly in patients with impaired liver function or those who have undergone liver transplantation, both renal and liver functions should be regularly checked. During the use of this medication, serious side effects such as lactic acidosis and fatty liver may occur, so if symptoms appear, immediate consultation with a healthcare provider is necessary. Moreover, sudden discontinuation of this medication may lead to rapid deterioration of hepatitis B, so it should be done carefully under medical supervision. This drug is not recommended for HIV-infected patients, and it is important to be tested for HIV before using this medication. Patients with lactose intolerance or an allergy to any component of this medication should not take it. Patients with impaired renal function need dosage adjustments, and hemodialysis patients are advised to take the medication post-dialysis. Women who are pregnant or breastfeeding should carefully consider the effects of this medication on the fetus or infant before use. Generally, this medicine is most effective when taken on an empty stomach, as food may reduce its absorption. Side effects such as headache, fatigue, dizziness, dyspepsia may occur, so if symptoms are severe, inform healthcare providers. Long-term use requires liver function testing, and if any abnormalities are found, consideration should be given to discontinuation of treatment. This drug may have possible interactions when taken with other renal-excreted medications, so caution is needed in combination therapy. When storing, keep it out of reach of children, avoid direct sunlight, and store at room temperature.

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

This medication should be stored in a closed container to prevent exposure to air and light. Additionally, it is advisable to keep the temperature between 15°C and 30°C. This helps maintain the drug's efficacy and safety.

Appearance

White to grayish-white, triangular film-coated tablet

Package unit

30 tablets/PTP