Baraclude Tablet 1 mg (Entecavir)

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. (Pharmacokinetic properties in patients with renal impairment: See “8. Administration to patients with renal impairment” under Precautions for Use.)

Child dose

Dosages for lamivudine-resistant patients or patients aged 16 years and older are specified, but there are no separate dosage instructions for children under 16 years.

This medicine is used for the treatment of liver diseases, especially prescribed for chronic hepatitis B patients. Caution is needed in patients with liver function impairment due to the risk of serious liver issues such as lactic acidosis and steatosis when using this medicine. During treatment, liver function tests and clinical symptoms should be monitored regularly, and if abnormalities are detected, the use of this medicine should be stopped immediately. Sudden discontinuation of this medicine may lead to acute exacerbation of hepatitis, so it should be done cautiously after consulting a specialist. This medicine is not recommended for patients co-infected with HIV and hepatitis B who have not yet received HIV treatment, and an HIV test is required before use. Patients with allergies to this medicine or its components, or those with certain genetic lactose intolerance disorders should not take this product. Patients with impaired renal function may require dosage adjustments, and it is advisable for dialysis patients to take this medicine after dialysis. Liver transplant patients or those taking immunosuppressants that may affect renal function should monitor their kidney function closely before and during the use of this medicine. Common side effects that may occur with this medicine include headache, fatigue, dizziness, nausea, etc., and immediate consultation with medical personnel is recommended in case of severe side effects. During pregnancy, the risks and benefits to the fetus should be carefully considered before use, and breastfeeding women should discontinue breastfeeding or reconsider the use of the medicine. This medicine's absorption may be reduced when taken with food, so it is recommended to take it on an empty stomach. When used with other renal-excreting drugs, blood concentrations may increase, so careful observation for adverse reactions is necessary during combination therapy. There is a possibility of resistance development with long-term use, so regular checks on treatment effectiveness and viral status are important. The pharmacokinetics of this medicine may vary by age, such as in children and elderly patients, so dosage adjustments should be made according to age and renal function. In the case of overdose, there is no specific antidote, so appropriate supportive care should be implemented according to symptoms. For storage, keep this medicine out of reach of children, avoid direct sunlight, and store it at room temperature.

Hyperlipidemia, fatty liver, hepatomegaly, liver metabolic dysfunction, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, vertigo, drowsiness, insomnia, anaphylactic reaction, increased aminotransferases, hair loss, rash, epigastric pain, heartburn, pruritus, chest pain, constipation, abdominal pain, low back pain, abdominal discomfort, nasal discharge, hematuria, thrombocytopenia, hyperglycemia, diabetes, hepatic neoplasm, intra-abdominal bleeding, ascites, portal hypertension gastrointestinal syndrome, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disorder, gastric angiodysplasia, chronic sinusitis, abdominal pain, rash, unpleasant taste, neutropenia

This medicine should be stored in a tightly closed container to prevent air ingress and is best kept at room temperature between 15 degrees and 30 degrees Celsius. Proper storage will help maintain the medicine's effectiveness and prevent degradation.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP) x 3