Encaron 1.0 mg (Entacavir)

Adult dose

Administer 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 aged 16 years or older with lamivudine resistance, i.e., patients 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. In patients with renal impairment, the oral clearance of this drug decreases as creatinine clearance decreases. For patients with creatinine clearance below 50mL/min, including patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), adjust the dose as follows. 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 less than 0.5mg, use of the syrup formulation is recommended. b: If administered on a hemodialysis day, administer this drug 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

Patients over 16 years of age should take 1 mg of entecavir orally once daily on an empty stomach, depending on the presence of lamivudine resistance.

This drug can cause serious liver problems such as lactic acidosis and steatosis in patients with liver disease, so those with poor liver health should be particularly cautious. Abrupt discontinuation of this drug can lead to rapid deterioration of hepatitis B, so treatment should only be stopped under a doctor's direction. Patients infected with HIV who use this drug alone without effective treatment are at risk of developing resistance to HIV treatment, so an HIV test is required before use. Patients with allergies to this drug or its ingredients, or those with certain genetic issues such as lactose intolerance should not take this drug. Patients with impaired kidney function or those undergoing dialysis require dosage adjustments, and liver transplant recipients need careful monitoring of kidney function. This drug may cause side effects such as headaches, fatigue, dizziness, and nausea. Treatment should be stopped immediately if liver function test results worsen. Taking this drug with food may reduce absorption, so it is recommended to take it on an empty stomach. Since this drug is primarily excreted through the kidneys, co-administration with other medications that may affect kidney function should be closely monitored for side effects. During pregnancy, it should only be used when absolutely necessary due to risks to the fetus, and during breastfeeding, it is recommended to either stop breastfeeding or discontinue the medication. Pediatric and elderly patients should also be monitored carefully for kidney function and adverse reactions when using this medication. No specific harm has been reported in cases of overdose, but some can be removed by dialysis if necessary, and medical advice should be sought immediately in case of adverse reactions. This drug should be stored in a sealed container to prevent air infiltration, kept in a cool place between 15 and 30 degrees. Proper storage ensures the maintenance of the drug's efficacy.

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

This drug should be stored in a sealed container to prevent air infiltration and kept in a cool place between 15 and 30 degrees. Proper storage will help maintain the drug's effectiveness for a long time.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP*3)