Baraclude 0.5 mg (entecavir hydrate)

Adult dose

Take this medicine orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). The recommended dose is 0.5 mg of entecavir once daily by mouth. Patients with lamivudine resistance, i.e., patients 16 years of age or older who experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: 1 mg of entecavir once daily on an empty stomach Patients with renal impairment: As creatinine clearance decreases in patients with renal impairment, the oral clearance of this medicine decreases. Adjust the dose as follows in patients with creatinine clearance below 50 mL/min, including those receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Creatinine clearance (mL/min) ≥ 50: entecavir dose 0.5 mg once daily; entecavir dose for patients with lamivudine resistance 1 mg once daily Creatinine clearance (mL/min) 30 - <50: entecavir dose 0.25 mga once daily or 0.5 mg every 48 hours; entecavir dose for patients with lamivudine resistance 0.5 mg once daily or 1 mg every 48 hours Creatinine clearance (mL/min) 10 - <30: entecavir dose 0.15 mga once daily or 0.5 mg every 72 hours; entecavir dose for patients with lamivudine resistance 0.3 mga once daily or 1 mg every 72 hours Creatinine clearance (mL/min) <10, hemodialysisb or CAPD: entecavir dose 0.05 mga once daily or 0.5 mg every 7 days; entecavir dose for patients with lamivudine resistance 0.1 mga once daily or 1 mg every 7 days a : For doses below 0.5 mg, 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” in Precautions for use)

Child dose

This includes patients aged 16 years and older who have experienced persistent replication of the hepatitis B virus despite lamivudine treatment or have lamivudine-resistant mutations, so for those under 16 years of age, it is not recommended.

This medication should be used with special caution in patients with impaired liver function or those at high risk of liver disease, as serious side effects such as lactic acidosis and fatty liver may occur. Abrupt discontinuation of this medication can lead to rapid worsening of hepatitis B, so liver function must be carefully monitored for several months after discontinuation. It is recommended not to use this medication in patients co-infected with HIV and hepatitis B who are not receiving HIV treatment. Patients with allergies to this medication or its components, or with certain genetic diseases such as lactose intolerance, should not take it. Renal function must be adjusted in patients with decreased renal function, and those undergoing dialysis should closely monitor their renal function during treatment with this medication. In liver transplant patients on immunosuppressants, renal function must be thoroughly evaluated before and during the administration of this medication. During treatment with this medication, side effects such as headache, fatigue, dizziness, and nausea may occur, and if symptoms are severe, consultation with a healthcare professional is necessary. If liver function test results are abnormally elevated, treatment may need to be temporarily suspended, so regular liver function tests are required. This medication should be taken on an empty stomach as absorption may be reduced when taken with meals. Pregnant women should only take this medication if necessary, considering the risks to the fetus, and nursing mothers should consider discontinuing breastfeeding or the medication, as it may be excreted in breast milk. Use in pediatric patients is recommended only for those aged 2 years and older, as safety and effectiveness in children under 2 years have not been established. In case of overdose, there is no specific antidote, and appropriate supportive care should be provided according to the symptoms, as some of the medication may be removed by hemodialysis. Since this medication is primarily excreted through the kidneys, caution should be exercised when taking it with other medications that may affect renal function. When storing, keep in a tightly closed container out of the reach of children, away from direct sunlight, and at room temperature.

• Headache
• fatigue
• dizziness
• nausea
• diarrhea
• indigestion
• vomiting
• drowsiness
• insomnia
• anaphylactic reactions

This medication should be stored in a tightly closed container to avoid exposure to air and light, maintaining a temperature between 15 and 30 degrees Celsius at room temperature. Proper storage will help maintain the medication's effectiveness and prevent degradation.

Appearance

white triangular film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP) × 3]