Baraclude 0.5 mg (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) Administer entecavir 0.5mg orally once daily. Patients resistant to lamivudine, 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: entecavir 1mg once daily on an empty stomach. In adult patients with renal impairment, the oral clearance of this medicine decreases as creatinine clearance decreases. In adult patients with creatinine clearance less than 50mL/min, including patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), adjust the dose as shown in Table 2. Creatinine clearance (mL/min) ≥ 50: Entecavir dose 0.5 mg once daily / Entecavir dose for lamivudine-resistant 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 for lamivudine-resistant 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 for lamivudine-resistant 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 for lamivudine-resistant patients 0.1 mg a once daily or 1 mg every 7 days a: Use of the oral solution is recommended for doses less than 0.5mg. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session.

Child dose

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

This medication should be used with caution in patients with liver disease. Severe liver enlargement accompanied by lactic acidosis and steatosis may occur with the sole use of nucleoside analogs; hence, patients with compromised liver function should be particularly cautious when using this drug. Abrupt discontinuation of this drug may result in a rapid deterioration of hepatitis B, so liver function should be carefully monitored for several months after stopping treatment. If a patient with undiagnosed HIV infection uses this drug, there is a risk of developing resistance to HIV treatment, so it is important to obtain an HIV test before using this medication. Patients with a known allergy to this drug or its components, and those with lactose intolerance or specific genetic metabolic disorders should not take this medication. Patients with renal impairment or those undergoing dialysis need dosing adjustments, while liver transplant patients should be administered cautiously with careful monitoring of kidney function. Headache, fatigue, dizziness, nausea, and other symptoms may occur during treatment, and if liver function test results are abnormally elevated, medical consultation is required immediately. Pregnant women should only use this drug under the doctor's judgment considering the risk to the fetus, and breastfeeding women are recommended to discontinue breastfeeding or the medication. Since this drug is mainly excreted via the kidneys, careful observation for adverse reactions is necessary when used in conjunction with other drugs affecting renal function. Taking this medication with food may reduce absorption, so it is recommended to take it on an empty stomach. Reports of special adverse reactions due to overdose are rare; however, patients should be carefully monitored in cases of overdose and appropriate supportive treatment provided if required. When administering to children or elderly patients, dosing adjustments and monitoring of renal function are necessary, and safety and efficacy have not been established for children under 2 years.

Lactic acidosis, steatosis, hepatic enlargement, impaired hepatic metabolism, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, lightheadedness, drowsiness, insomnia, anaphylactic reactions, increased aminotransferases, hair loss, rash, upper abdominal pain, heartburn, itching, chest pain, constipation, abdominal pain, lumbago, abdominal discomfort, rhinorrhea, hematuria, thrombocytopenia, hyperglycemia, diabetes, liver neoplasm, intraperitoneal hemorrhage, ascites, portal hypertension gastrointestinal syndrome, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disorders, gastric angioma, chronic sinusitis, abdominal pain, rash, bad taste, neutropenia

This medication may be sensitive to air or moisture and should be stored in a tightly sealed container. It is recommended to maintain storage temperatures between 15 and 30 degrees Celsius. Proper storage will help maintain the medication's efficacy.

Appearance

White to grayish-white triangular film-coated tablet

Package unit

30 tablets/PTP