Entecavir Tablets (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) 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 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 characteristics in patients with renal impairment: see Precautions for Use, “8. Administration to patients with renal impairment”)

This medication is used for treating liver disease and may cause severe liver-related side effects such as lactic acidosis and steatosis. Patients with impaired liver function should be particularly cautious. Stopping treatment may lead to a rapid worsening of hepatitis B, so liver function should be closely monitored for several months after discontinuation. Use is not recommended for patients co-infected with HIV, and testing for HIV infection is required prior to treatment. Patients allergic to this medication or its components, or those with genetically inherited lactose intolerance, should not take it. Dose adjustment is necessary for patients with impaired kidney function, and liver transplant patients or those on medications that may affect kidney function should be closely monitored for kidney function. Common side effects may include headache, fatigue, dizziness, nausea, etc., and regular liver function tests are required as abnormalities or worsening of hepatitis may occur. Drug absorption may decrease if taken with food, so it is advisable to take it on an empty stomach. Because this drug is excreted by the kidneys, patients should be closely monitored for side effects when taken with medications that affect kidney function. During pregnancy, the risks to the fetus versus benefits should be carefully considered, and in breastfeeding, either breastfeeding should be discontinued or medication use should be stopped. It is approved for use in children aged 2 years and older, and safety and efficacy have not been established in children under 2 years old. There is no specific antidote for overdose, so appropriate treatment should be given based on symptoms, although some can be removed through dialysis. It is important to keep this medication out of the reach of children, store it in a tightly closed container away from direct sunlight, and at room temperature.

Hyperlactatemia, steatosis, hepatomegaly, hepatic metabolic dysfunction, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, lightheadedness, drowsiness, insomnia, anaphylactic reaction, increased aminotransferases, hair loss, rash, upper abdominal pain, heartburn, itching, cold, cough, chest pain, constipation, abdominal pain, low back pain, abdominal discomfort, runny nose, intraperitoneal hemorrhage, ascites, portal hypertension-related complications, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disorders, gastric hemangioma, chronic sinusitis, abdominal pain, rash, unpleasant taste, neutropenia

This medication should be stored in a tightly closed container to prevent air from entering, and it should be kept in a cool place between 15 to 30 degrees Celsius. Proper storage helps maintain the efficacy of the drug for a long time.

Appearance

Film-coated tablet in a triangular shape, white to whitish color

Package unit

30 tablets (10 tablets/PTP) X 3