Jungheon Entecavir Hydrate Tablet 1 mg

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). The recommended dose is 0.5mg of entecavir 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: 1mg of entecavir 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 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 less than 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

For patients with lamivudine resistance or those aged 16 years and older, they should take 1 mg of entecavir orally once a day on an empty stomach. Specific dosage instructions for children are not stated.

This medication is a chronic hepatitis B treatment affecting the liver, and serious side effects like liver dysfunction or lactic acidosis may occur, so caution is required. Risk of side effects is higher in patients with liver disease risk factors, women, and obese patients. If abnormal liver function test results occur, the medication should be stopped immediately, as hepatitis may rapidly worsen upon discontinuation, necessitating careful monitoring of liver function. This medication is not recommended for patients co-infected with HIV and hepatitis B who are not receiving HIV treatment, so an HIV test is mandatory. Patients with allergies to this medication or its ingredients, or genetic issues such as lactose intolerance, should not be given this medication. Patients with decreased renal function or those undergoing dialysis must adjust the dosage, and liver transplant patients should carefully monitor kidney function. This medication is more effective when taken on an empty stomach, as food may reduce absorption. During the treatment period, side effects such as headache, fatigue, dizziness, and nausea may occur; if symptoms are severe, consultation with medical staff is required. This medication is excreted through the kidneys, so caution is needed when combined with other drugs that may affect renal function as side effects can increase. During pregnancy, it should be used cautiously considering the risk to the fetus, and breastfeeding should be discontinued or the drug should be halted. Its safety and efficacy have only been established in pediatric patients aged 2 years and older, and its use is not recommended in patients under 2 years of age. Elderly patients may experience increased drug concentration due to decreased renal function, necessitating dosage adjustments and monitoring of renal function. There is no specific antidote for overdose, so supportive care based on symptoms should be administered under medical supervision. This medication should be stored out of reach of children, away from direct sunlight, and at room temperature.

Fatty liver, fatty infiltration, severe liver enlargement, impaired liver metabolism, headache, fatigue, dizziness, nausea, diarrhea, indigestion, vomiting, disorientation, drowsiness, insomnia, anaphylaxis-like reaction, increased aminotransferases, hair loss, rash, upper abdominal pain, heartburn, itching, chest pain, constipation, abdominal pain, lower back pain, abdominal discomfort, runny nose, hematuria, thrombocytopenia, hyperglycemia, diabetes, liver tumors, intra-abdominal bleeding, ascites, portal hypertension-related gastric disease, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disorders, gastric angioedema, chronic sinusitis, abdominal pain, rash, bad taste, neutropenia

This medication should be stored in a sealed container to prevent air or moisture ingress, ideally at room temperature between 15 and 30 degrees Celsius. This will help maintain the medication's efficacy and prevent degradation.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets (10 tablets/1 PTP X 3)