Donggwang Entacavir Tablet 1mg
Entecavir 1.06mg
Tablet · Prescription medication
Donggwang Pharmaceutical Co., Ltd.
MFDS item code 201501922 · Approved 2015.04.09
This product's status changed to Expired on 2025.04.09. It may no longer be sold, so consult a doctor or pharmacist before taking it.
Treatment of chronic hepatitis B virus infection in patients aged 16 years and older
This medication is used for adults (16 years and older) with chronic hepatitis B who have active viral replication and consistently elevated serum aminotransferases (ALT or AST) or when active disease is confirmed by biopsy. It helps improve liver function and inhibit the progression of chronic hepatitis B.
Administer this drug orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Administer this drug orally once daily at a dose of 0.5mg of entecavir. Patients aged 16 years and older with lamivudine resistance, that is, patients who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: 1mg of entecavir once daily on an empty stomach Patients with renal failure: In patients with renal failure, the oral clearance of this drug decreases as creatinine clearance decreases. For patients with creatinine clearance below 50mL/min, including those receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), adjust the dose as follows. Creatinine clearance (mL/min) | Entecavir dose | Entecavir dose in patients with lamivudine resistance ≥ 50 | 0.5 mg once daily | 1 mg once daily 30 - <50 | 0.25 mg once daily a or 0.5 mg every 48 hours | 0.5 mg once daily or 1 mg every 48 hours 10 - <30 | 0.15 mg once daily a or 0.5 mg every 72 hours | 0.3 mg once daily a or 1 mg every 72 hours <10, hemodialysis b or CAPD | 0.05 mg once daily a or 0.5 mg every 7 days | 0.1 mg once daily a 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 drug after the hemodialysis session.
Caution is required when administering this medication to patients with liver disease or impaired liver function due to the risk of severe side effects such as lactic acidosis and steatosis. If treatment is discontinued, there is a risk of exacerbation of hepatitis; therefore, regular monitoring of liver function is necessary even after discontinuation of treatment, and the physician's instructions must be followed. In patients infected with HIV who are not receiving treatment, the use of this drug may lead to resistance to HIV treatment; therefore, HIV status must be checked before use. Patients with allergies to this drug or its components should not use it, nor should patients with lactose intolerance take this medication. Patients with impaired kidney function or those undergoing dialysis should consult with their physician for dosage adjustments. Patients who have undergone liver transplantation should carefully monitor kidney function before and during the administration of this drug. This drug may cause side effects such as headache, fatigue, dizziness, and nausea; patients should consult with their physician if symptoms worsen. Taking this medication with food may decrease its effectiveness, so it is advisable to take it on an empty stomach. Pregnant or breastfeeding women should consult with a physician before taking this medication, as the effects on the fetus or infant are not clearly established. When administering to children or elderly patients, careful dosage adjustments should be made considering kidney function. There is no specific antidote for overdose, so if symptoms occur, immediate medical attention should be sought. Since this drug is excreted by the kidneys, taking it with other medications that affect kidney function may increase the risk of side effects; patients should inform their physician of any medications they are currently taking. During treatment, regular liver function tests should be performed, and if signs of liver dysfunction occur, medical personnel should be notified immediately. This medication is used for the treatment of hepatitis B virus; however, since treatment effects may not manifest or resistance can develop, regular check-ups are necessary. Store this medication out of reach of children, away from direct sunlight, and at room temperature.
Not everyone experiences these, and they can vary from person to person.
This medication should be stored in a tightly closed container to protect it from exposure to air and light. It is preferable to keep it in a cool place between 15 and 30 degrees Celsius. Proper storage aids in maintaining the drug's effectiveness.
Pink triangular film-coated tablet
30 tablets/box [(10 tablets/PTP x 3)]
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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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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.