Encarvir 0.5 mg Tablet (Entacavir)

Adult dose

Administer this medicine 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 16 years of age or older who have experienced persistent replication of hepatitis B virus despite lamivudine treatment, or who have lamivudine-resistant mutations: entecavir 1mg orally once daily on an empty stomach Patients with renal impairment: 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 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 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 Precautions for Use, “8. Administration to Patients with Renal Impairment”)

Child dose

Includes patients aged 16 and older with lamivudine-resistant mutations, but no separate pediatric dosage is specified.

This medication is used for the treatment of liver disease and can affect liver function, so patients with impaired liver function should take special care. During treatment, serious side effects such as lactic acidosis and hepatic steatosis may occur; thus, particularly women, obese patients, and those who have used nucleoside analogs for an extended period should be more cautious. If there are abnormal results from liver function tests or symptoms of lactic acidosis occur, discontinue use immediately and consult a doctor. Discontinuation of treatment may lead to a sudden worsening of hepatitis B, so liver function should be closely monitored for several months after stopping treatment. This drug is not recommended for patients co-infected with HIV and hepatitis B who are not receiving HIV treatment, and an HIV infection test is necessary before administration. Patients with allergies to this medication or its components, or with genetic lactose metabolism disorders, should not take this drug. Patients with impaired kidney function, especially those undergoing hemodialysis or peritoneal dialysis, require dosage adjustment, and liver transplant recipients should also monitor kidney function carefully. Common side effects such as headache, fatigue, dizziness, nausea may occur, and liver function test levels may rise, hence regular monitoring is required. Taking the medication with food can decrease the absorption of the drug, so it is best taken on an empty stomach. This drug is excreted through the kidneys; caution should be exercised for potential side effects when taken with other medications that can affect kidney function. The use of this drug during pregnancy has unclear effects on the fetus, and it should only be used if the benefits outweigh the risks, while breastfeeding should be stopped or medication discontinued. In children, use is permitted only for those aged 2 years and older, and safety and efficacy have not been established for those under 2 years of age. Elderly patients may experience reduced kidney function, so dosage adjustment and kidney function monitoring are necessary. In cases of overdose, there is no specific antidote available, so appropriate supportive care should be provided according to symptoms, and some medications may be removed by hemodialysis. This medication should be kept out of reach of children, stored in a sealed container, away from direct sunlight, and at room temperature. Regular liver and kidney function tests before and during treatment are important to identify any abnormalities.

• Hyperlipidemia
• fatty liver
• hepatomegaly
• impaired liver metabolism
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

This medication should be stored in a sealed container for safety. For domestic use, it is advisable to store the medication at a temperature between 15 and 30 degrees Celsius. For export medication, it should be stored at room temperature, between 1 and 30 degrees Celsius. This helps maintain the drug's effectiveness and prevents deterioration.

Appearance

1. For domestic use: white to off-white triangular film-coated tablet 2. For export: white to light yellowish triangular film-coated tablet

Package unit

For domestic use: 30 tablets (10 tablets/PTP x 3), for export: 70 tablets (14 tablets/PTP x 5)