Barud tablet 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). 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.

Child dose

No specific dosage for those under 16 years is specified.

This drug may cause serious hepatic enlargement, including hepatic steatosis and fatty liver, especially in women with liver disease, so caution should be exercised in patients with compromised liver function. After discontinuation of treatment, hepatitis B may worsen rapidly, requiring regular monitoring of liver function even after treatment ends. This drug is not recommended for patients with concurrent HIV and hepatitis B infections who are not receiving HIV treatment; a test for HIV infection must be conducted prior to administration. Patients with allergies to this drug or its components, or with certain hereditary conditions such as lactose intolerance, should not take it. Dose adjustment is required in patients with impaired renal function, especially those undergoing hemodialysis or peritoneal dialysis, and renal function should be monitored regularly. Patients who have undergone liver transplantation must monitor renal function carefully before and during the administration of this drug. Symptoms such as headaches, fatigue, dizziness, nausea may occur during treatment; if abnormal symptoms persist, consulting a doctor is advised. If liver function test values rise or if hepatotoxic symptoms manifest, this drug should be discontinued immediately and medical advice sought. Absorption may be reduced when taken with food, so it is preferable to take it on an empty stomach. As this drug is excreted via the kidneys, caution is needed when taken with other medications that may affect renal function. During pregnancy, this drug should only be used when necessary, considering the risks to the fetus; nursing mothers are advised to either stop breastfeeding or discontinue this drug. Use is recommended only in children aged 2 years and older; safety and efficacy have not been established in those under 2 years. Elderly patients may require dose adjustments and renal function testing due to potential declines in renal function. In cases of overdose, there is no specific antidote, and appropriate supportive treatment should be administered based on symptoms; some drugs may be removed by hemodialysis. This drug should be stored out of reach of children, away from direct sunlight, and at room temperature. Transferring medication to another container or diluting syrup is not advised as it may affect the quality.

• Fatty liver
• fatty degeneration
• liver enlargement
• impaired liver metabolic function
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• indigestion

This drug should be stored in a tightly sealed container to prevent air or moisture from entering. Additionally, it is best to store the medicine at a temperature between 15 and 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance

White to grayish-white triangular film-coated tablet

Package unit

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