Barud Tablet 1 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). The dose of this medicine is entecavir 0.5mg orally once daily. Patients with lamivudine resistance, i.e., patients 16 years of age or older who have experienced persistent hepatitis B virus replication despite lamivudine treatment or who have lamivudine-resistant mutations: 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 creatinine clearance below 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 patients with lamivudine resistance 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 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 mg a once daily or 0.5 mg every 72 hours; entecavir dose in patients with lamivudine resistance 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 patients with lamivudine resistance 0.1 mg a once daily or 1 mg every 7 days a: For doses below 0.5mg, use of the oral solution is recommended. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session. (Pharmacokinetic properties in patients with renal impairment: See section “8. Administration to patients with renal impairment” under Precautions for Use.)

Child dose

The dosage is specified for patients with lamivudine resistance or patients over 16 years old, therefore, no separate dosing instructions are provided for children under 16.

This medication should be used with caution in patients with liver disease. Severe side effects such as lactic acidosis or steatosis may occur in cases of severe liver dysfunction, so regular liver function tests should be conducted and use should be discontinued if abnormalities are found. Abrupt discontinuation of this drug can lead to rapid deterioration of hepatitis B, so liver function should be closely monitored for several months after stopping treatment. Treatment may be resumed if necessary. It is advisable not to use this drug in HIV-infected patients who are not yet receiving HIV treatment. Tests for HIV infection must be conducted. Patients with hypersensitivity to this drug or genetic disorders such as lactose intolerance should not take it. Patients with impaired kidney function, especially those undergoing hemodialysis or peritoneal dialysis, require dose adjustment, and liver transplant patients should closely monitor their kidney function if taking other medications that may affect it. Common side effects of this drug include headaches, fatigue, dizziness, nausea, but they are mostly mild and rarely lead to treatment discontinuation. Taking this drug with food may reduce absorption, so it is recommended to take it on an empty stomach. During pregnancy, the potential risks to the fetus and the benefits of this medication must be carefully considered, and if breastfeeding, discontinuation of either this medication or breastfeeding is recommended since this drug can be secreted into breast milk. Since this drug is excreted by the kidneys, caution is needed when used in conjunction with other medications that can impact kidney function, and potential drug interactions should be discussed with a physician. Specific patient groups such as children, the elderly, and pregnant women may require dose adjustments or special attention, especially children under 2 years of age, as safety and efficacy have not been established. In case of overdose, there is no specific antidote, so symptoms must be monitored, and supportive treatment may be required if needed. This medication should be stored under appropriate conditions and kept out of reach of children.

• Lactic acidosis
• steatosis
• hepatomegaly
• liver metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

This medication should be stored in a tightly closed container that is well-ventilated, and it is important to maintain a temperature between 15 to 30 degrees Celsius. Proper storage conditions help to maintain the drug's effectiveness and prevent degradation.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets/Alu-Alu (10 tablets/Alu-Alu * 3)