Enterone Tablet 1mg (Entecavir)
Entecavir 1.065mg
Tablet · Prescription medication
Cosmax Pharma Co., Ltd.
MFDS item code 201907011 · Approved 2019.10.01
This product's status changed to Approval withdrawn on 2024.01.10. It may no longer be sold, so consult a doctor or pharmacist before taking it.
Treatment of active chronic hepatitis B virus infection
This medication is used for adult patients who are infected with chronic Hepatitis B virus and have confirmed active viral replication or a persistent increase in serum aminotransferases (ALT, AST) indicating liver damage based on blood tests. Treatment is also necessary when an active disease of the liver is confirmed through histological examination. This medication effectively treats chronic Hepatitis B by improving liver function and suppressing viral activity.
This medicine should be administered 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 aged 16 years and older who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: administer entecavir 1mg once daily on an empty stomach. Patients with renal failure: In patients with renal failure, 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 continuous ambulatory peritoneal dialysis (CAPD). Creatinine clearance (mL/min) ≥ 50: Entecavir dose 0.5 mg once daily; entecavir dose for 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 for 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 for 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 for 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 medicine after the hemodialysis session.
For patients aged 16 years and older who are resistant to lamivudine, Entecavir 1mg is administered orally once daily on an empty stomach.
This medication has been reported to cause serious side effects that may affect the liver; therefore, patients with poor liver health or risk factors must exercise special caution. Sudden discontinuation of this medication may worsen hepatitis; thus, liver function should be closely monitored under a physician's direction when stopping treatment. Patients simultaneously infected with HIV and Hepatitis B may experience negative effects on HIV treatment when using this medication alone, thus HIV treatment must be received. Patients with allergies to this medication or its components should not take it, nor should patients with specific genetic issues such as lactose intolerance. Patients with impaired renal function should have their dosage adjusted, especially those undergoing hemodialysis or peritoneal dialysis, who require careful monitoring during administration. Liver transplant patients should closely observe changes in renal function when this medication is combined with immunosuppressants. During treatment, symptoms such as headache, fatigue, dizziness, nausea, and others may occur, and if abnormal liver function test results arise, treatment cessation should be considered. Pregnant women should use this medication cautiously due to potential risks to the fetus; breastfeeding mothers should also consider stopping breastfeeding or the medication due to possible secretion into breast milk. This medication may have reduced absorption when taken with food; hence, it is recommended to take it on an empty stomach. No specific harm has been reported in cases of overdose, but if needed, some can be removed via hemodialysis, so immediate hospital visitation is necessary in case of overdose. When storing this medication, keep it out of reach of children, avoid direct sunlight, and store it at room temperature.
Lactation syndrome, steatosis, hepatomegaly, impaired hepatic metabolic function, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, lightheadedness, drowsiness, insomnia, anaphylactic reaction, increase in aminotransferase enzymes, hair loss, rash, upper abdominal pain, heartburn, hematuria, hyperglycemia, diabetes, pruritus, chest pain, constipation, abdominal pain, back pain, abdominal discomfort, runny nose, hepatic neoplasm, intra-abdominal hemorrhage, ascites, portal hypertension gastrointestinal disease, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin diseases, gastric angiofibroma, chronic sinusitis, abdominal pain, rash, unpleasant taste, neutropenia
Not everyone experiences these, and they can vary from person to person.
This medication should be stored in an airtight, sealed container, and it is important to maintain the temperature between 15 and 30 degrees Celsius. Proper storage will help in retaining the medication's effectiveness.
Pink triangular film-coated tablet
30 tablets (10 tablets/PTP x 3)
Even with the same ingredient, strength, dosage form and how it is taken can differ.
Entecavir 1.065mg
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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.
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For anything that needs medical judgment, consult a doctor or pharmacist.
This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.