Ceviran 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). Administer entecavir 0.5mg orally once daily. Patients with lamivudine resistance, i.e., patients aged 16 years or older who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: Administer entecavir 1mg orally 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: Use of the syrup formulation is recommended for doses less than 0.5mg. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session.

Child dose

No specific dosage recommendation for patients under 16 years old.

This medication can cause serious side effects such as lactic acidosis and steatosis in patients with severely impaired liver function, so caution is needed. Especially in women and obese patients, these side effects have been reported more frequently, and patients with poor liver function are at higher risk for lactic acidosis. If liver function abnormalities are suspected, the use of this medication should be temporarily halted. Additionally, abrupt discontinuation of this medication can lead to rapid deterioration of hepatitis B, so liver conditions must be closely monitored for several months after therapy cessation. The use of this medication is not recommended for patients co-infected with HIV and hepatitis B who are not receiving HIV treatment. Patients with an allergy to any component of this medication or specific hereditary conditions like lactose intolerance should not take it. Patients with reduced renal function or those undergoing hemodialysis need medication dosage adjustments, and liver transplant patients should be closely monitored for kidney function. While taking this medication, side effects such as headache, fatigue, dizziness, nausea, etc., may occur, and if symptoms become severe, consultation with healthcare professionals is necessary. It is important to regularly check liver function as the medication may worsen liver function test results. This medication is more effectively absorbed when taken on an empty stomach and its efficacy may be reduced when taken with food. During pregnancy, it should only be used if necessary, taking fetal risk into consideration, and breastfeeding should be discontinued or medication intake should be halted in nursing mothers. Caution should be taken when administering this medication to special populations such as children, the elderly, and pregnant women, following healthcare provider instructions. In case of overdose, immediate contact with a healthcare facility for appropriate measures is required, and some medications may be removed by hemodialysis. Since this medication is primarily eliminated through the kidneys, careful monitoring for side effects is necessary when used with other medications that might affect renal function. When storing, keep it out of reach of children, avoid direct sunlight, and store within the recommended temperature range.

• Lactic acidosis
• steatosis
• liver enlargement
• impaired liver metabolism
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

This medication should be stored in a tightly closed container to protect it from air and light. Additionally, it is best to store it at room temperature between 15 and 30 degrees Celsius. This helps maintain the medication's efficacy and safety.

Appearance

White-gray triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTPX3)