Entacavir 0.5 mg Tablet (Entacavir)

Adult dose

Administer this medicine 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-resistant mutations: Administer entecavir 1mg once daily on an empty stomach. Patients with renal impairment: As creatinine clearance decreases in patients with renal impairment, the oral clearance of this medicine 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 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 below 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

Dosage is specified for patients aged 16 years and older with lamivudine-resistant strains, which are those who have experienced persistent replication of Hepatitis B virus despite lamivudine treatment or have documented lamivudine-resistant mutations.

This medication may cause serious side effects such as lactic acidosis and steatosis in patients with severely impaired liver function, so caution is needed. The risk may be higher in women and obese patients, so patients with risk factors for liver disease should use it more cautiously. Sudden discontinuation of this medication can lead to rapid deterioration of Hepatitis B; therefore, liver function should be closely monitored upon discontinuation, following doctor's instructions. It is not recommended to use this medication in patients co-infected with HIV who are not receiving treatment for HIV, and an HIV test is necessary before use. Patients with allergies to this medication or its ingredients or those with lactose intolerance should not take it. Dose adjustment is required for patients with impaired renal function, and particularly for patients undergoing hemodialysis, administration timing should be adjusted. Patients with liver transplants need to carefully monitor their kidney function when taking medications that may affect it. Common side effects may include headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, drowsiness, insomnia, hair loss, rash, bad taste, itching, heartburn, cold, constipation, abdominal pain, lower back pain, abdominal discomfort, and runny nose. The absorption of this medication is reduced when taken with food, so it is recommended to take it on an empty stomach. During pregnancy, the risks and benefits to the fetus should be carefully considered before use, and if breastfeeding, it should be discontinued or the medication should be stopped, as the drug may be excreted in breast milk. It is recommended for children aged 2 years and older; safety and efficacy have not been established for those under 2 years. Elderly patients may have a higher likelihood of reduced kidney function, so dose adjustment and kidney function monitoring are necessary. There is no specific antidote for overdose; appropriate treatment should be administered based on symptoms, and some drugs can be removed by hemodialysis. This medication is excreted through the kidneys, so interactions may occur when used concomitantly with other drugs affecting renal function.

Hyperlipidemia, liver enlargement, fatty liver, impaired liver metabolic function, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, lightheadedness, drowsiness, insomnia, anaphylactic reaction, increased aminotransferases, hair loss, rash, upper abdominal pain, heartburn, chest pain, cold, pruritus, constipation, abdominal pain, back pain, abdominal discomfort, rhinorrhea, hematuria, thrombocytopenia, hyperglycemia, diabetes, hepatic neoplasm, intra-abdominal hemorrhage, ascites, portal hypertension-related gastric disease, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disorders, gastric angiofibroma, chronic sinusitis, abdominal pain, rash, unpleasant taste, neutropenia

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, in a cool place between 15°C and 30°C. Proper storage will maintain the medication's effectiveness for a longer period.

Appearance

White to off-white triangular film-coated tablet

Package unit

30 tablets (10 tablets/Alu-Alu*3)