Entaclurud Tablet 0.5 mg (Entecavir)

Adult dose

Administer this drug 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 hepatitis B virus replication despite lamivudine treatment or who have lamivudine-resistance mutations: administer entecavir 1mg once daily on an empty stomach. Patients with renal impairment: In patients with renal impairment, the oral clearance of this drug decreases as creatinine clearance decreases. Adjust the dose as follows in patients with creatinine clearance less than 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 once daily a 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 once daily a or 0.5 mg every 72 hours / Entecavir dose in patients with lamivudine resistance 0.3 mg once daily a or 1 mg every 72 hours Creatinine clearance (mL/min) <10, hemodialysis b or CAPD: Entecavir dose 0.05 mg once daily a or 0.5 mg every 7 days / Entecavir dose in patients with lamivudine resistance 0.1 mg once daily a 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.

This drug can cause serious side effects such as lactic acidosis and fatty liver when used in patients with liver disease, so caution is needed. The risk may be greater, especially in female patients, obese patients, and patients who have used nucleoside analogs for an extended period. Patients with impaired liver function are at increased risk of lactic acidosis while using this medication and should have regular liver function tests. Stopping this drug suddenly may lead to a rapid deterioration of hepatitis B, so liver function should be monitored even after discontinuation. This drug is not recommended for patients coinfected with HIV and hepatitis B who are not receiving effective HIV treatment. Patients with allergies to any component of this drug or those with lactose intolerance should not take it. Patients with impaired kidney function or those undergoing dialysis require dose adjustments, and liver transplant patients should closely monitor kidney function. Common side effects may include headache, fatigue, dizziness, nausea, etc. If symptoms are severe, consult a physician. This drug should be taken on an empty stomach, as absorption is reduced when taken with food. During pregnancy, the risks to the fetus and the benefits of this drug should be carefully considered, and during breastfeeding, it is recommended to either stop breastfeeding or discontinue the drug. Elderly patients or patients with impaired kidney function may have increased drug levels in the body; thus, dose adjustments and kidney function monitoring are necessary. In case of overdose, there is no specific antidote; appropriate treatment should be administered according to symptoms, and some removal may be achieved through hemodialysis. Regular liver and kidney function tests should be conducted, and if unusual symptoms occur during treatment, inform the healthcare provider immediately.

Hyperlactatemia, steatosis, severe liver enlargement, liver metabolic dysfunction, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, lightheadedness, drowsiness, insomnia, anaphylactic reactions, increase in aminotransferases, hair loss, rash, upper abdominal pain, heartburn, chest pain, dyspepsia, constipation, abdominal pain, lower back pain, abdominal discomfort, runny nose, liver neoplasm, intra-abdominal hemorrhage, ascites, portal hypertension with gastrointestinal complications, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disease, gastric angiodysplasia, chronic sinusitis, abdominal pain, rash, unpleasant taste, neutropenia

Store this medication in a tightly closed container to avoid exposure to air, and the appropriate storage temperature is between 15 to 30 degrees Celsius. This prevents the medication from deteriorating and helps maintain its efficacy.

Appearance

White triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)