Baranub Tablet 1.0 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 0.5mg 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: 1mg of entecavir once daily on an empty stomach 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 50mL/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 0.5mg, use of the syrup formulation is recommended. b : If administered on a hemodialysis day, administer this medicine after the hemodialysis session.

Child dose

Limited to patients aged 16 years or older who are resistant to lamivudine.

Care should be taken when administering this drug to patients with liver disease due to the potential for serious side effects such as lactic acidosis and fatty liver. If liver function abnormalities occur during treatment with this medication, discontinue use immediately and consult a doctor. After stopping treatment, hepatitis B may worsen rapidly; therefore, liver function tests should be performed regularly for several months after treatment cessation. Use of this drug is not recommended for patients with concurrent HIV and hepatitis B who are not receiving HIV treatment, and HIV infection status should be confirmed before administration. Patients with allergies to this drug or its components, as well as those with certain genetic lactose intolerance disorders, should not take this medication. Dose adjustments are necessary for patients with impaired kidney function, and those undergoing dialysis should take this drug after dialysis. Patients who have undergone liver transplant surgery should carefully monitor kidney function prior to and during the use of this medication. This drug contains certain dyes, so patients allergic to these components should use it cautiously. Side effects such as headache, fatigue, dizziness, nausea, and other issues may occur while taking this medication; if symptoms are severe, consult a healthcare professional. During pregnancy, this medication should only be used when absolutely necessary, considering potential risks to the fetus; breastfeeding mothers should consider stopping breastfeeding or discontinuing the medication. In children, use is only recommended for those aged 2 years and older, as safety and efficacy have not been established in children under 2. This medication should be taken on an empty stomach, as taking it with food may reduce its absorption. No specific harmful symptoms have been reported in the case of overdose, but if an overdose occurs, inform medical staff immediately and receive necessary treatment. This drug is excreted through the kidneys, so dosage adjustment and monitoring of kidney function is important in patients with impaired renal function. Regular liver function tests during treatment are necessary to monitor liver health. Since this drug carries a risk of hepatitis exacerbation, liver function should be closely monitored even after discontinuation of treatment. This drug may interact with other medications; therefore, inform your doctor or pharmacist if you are taking other drugs. Store out of reach of children, keep tablets in a tightly closed container at room temperature, and syrup formulations should be stored in an opaque, tightly sealed container.

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

This medication should be stored in a tightly sealed container to avoid exposure to air and light. Additionally, it should be stored at room temperature between 15 and 30 degrees Celsius. This will help maintain the drug's effectiveness over time.

Appearance

Pink triangular film-coated tablets

Package unit

30 tablets/PTP