Antavir Tablet 0.5 mg (Entecavir)

Adult dose

• This medicine should be taken 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 aged 16 years or older who have 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 • Patients with renal impairment: 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 CAPD. Creatinine clearance (mL/min) Entecavir dose Entecavir dose in patients with lamivudine resistance ≥ 50 0.5 mg once daily 1 mg once daily 30 - <50 0.25 mg once daily a or 0.5 mg every 48 hours 0.5 mg once daily or 1 mg every 48 hours 10 - <30 0.15 mg once daily a or 0.5 mg every 72 hours 0.3 mg once daily a or 1 mg every 72 hours <10, hemodialysis b or CAPD 0.05 mg once daily a or 0.5 mg every 7 days 0.1 mg once daily a 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. (Pharmacokinetic properties in patients with renal impairment: See “8. Administration to patients with renal impairment” under Precautions for Use.)

Child dose

No specific dosage regimen mentioned for those under 16 years of age.

Great caution is required when administering this drug to patients with liver disease. Particular care should be taken in women and obese patients, as lactic acidosis and fatty liver may occur. If abnormalities in liver function or symptoms of lactic acidosis occur during treatment, use should be stopped immediately. After discontinuation, hepatitis may worsen, so liver function should be closely monitored for several months. It is not recommended to use this drug alone in patients co-infected with HIV and hepatitis B; an HIV test is required. Patients with allergy to this drug or its ingredients, or lactose intolerance should not receive this medication. Renal impairment patients, especially those undergoing hemodialysis or peritoneal dialysis, require dose adjustment, and liver transplant recipients should closely monitor kidney function. Side effects such as headaches, fatigue, dizziness, nausea may occur with this medication, and regular monitoring such as liver function tests is required. Taking this medicine with food may decrease absorption; therefore, it is recommended to take it on an empty stomach. When using this drug with other medications affecting renal function, close observation for side effects is necessary. During pregnancy, the risks and benefits to the fetus should be carefully considered. While breastfeeding, it is recommended to either stop breastfeeding or discontinue the medication. In children and elderly patients, kidney function should be closely monitored, and safety and efficacy have not been established in children under 2 years of age. In case of overdose, patients should be monitored and supportive treatment should be provided if needed. This medication should be kept out of reach of children, stored in a tightly sealed container, away from direct sunlight and at room temperature.

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

This medication should be stored in a tightly sealed container to prevent air or moisture ingress. It is best stored at room temperature between 15 degrees and 30 degrees.

Appearance

White to grayish, triangular-shaped film-coated tablets

Package unit

30 Tablets (10 Tablets/PTP × 3)