Entavir 1.0 mg (Entecavir) Tablets

Adult dose

This medicine should be taken orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). The usual dose is 0.5mg of entecavir 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: 1mg of entecavir 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. 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 ≥ 50 mL/min: entecavir dose 0.5 mg once daily; entecavir dose for patients with lamivudine resistance 1 mg once daily Creatinine clearance 30 - <50 mL/min: 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 10 - <30 mL/min: 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 <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 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” in Precautions for Use)

Child dose

Dosage for patients aged 16 years and older with lamivudine-resistant infection is specified separately; however, dosing guidelines for children under 16 are not specified.

Special caution is required when this drug is used in patients with severely impaired liver function or at risk for liver disease, as serious side effects such as lactic acidosis or steatosis may occur. Sudden discontinuation of this medication may result in rapid deterioration of hepatitis B, so liver function and condition should be closely monitored for several months after discontinuation. The use of this drug alone in patients infected with HIV but not receiving treatment may lead to HIV resistance and is not recommended. Patients with allergies to this medication or its ingredients, or those with genetic issues such as lactose intolerance, should not take this medication. Patients with impaired kidney function or those undergoing dialysis should have their dosage adjusted, and liver transplant patients should be closely monitored for kidney function during administration. It is recommended to take this medication on an empty stomach for better absorption; therefore, it is advisable not to take it with food. Headache, fatigue, dizziness, nausea, and other side effects may occur during treatment; if symptoms are severe, consult a physician. During pregnancy, this medication should only be used when necessary, considering the risks to the fetus, and it is recommended to stop breastfeeding or discontinue the medication while nursing. In children, it is only approved for those aged 2 years and older; safety and efficacy in those under 2 have not been established. Elderly patients may have reduced kidney function, and dosage adjustments and kidney function tests may be required. There is no specific antidote for overdose, so symptoms should be monitored, and appropriate treatment should be provided if necessary. Since this drug is excreted via the kidneys, the potential for side effects should be closely observed if taken with other medications that may affect kidney function or compete with it.

Hyperuricemia, steatosis, hepatomegaly, impaired hepatic metabolism, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, lightheadedness, drowsiness, insomnia, anaphylactic reaction, increased aminotransferases, hair loss, rash, abdominal pain, heartburn, chest pain, cold, pruritus, constipation, abdominal cramping, low back pain, abdominal discomfort, runny nose, hematuria, thrombocytopenia, hyperglycemia, diabetes, liver neoplasm, intra-abdominal hemorrhage, ascites, portal hypertension-related gastric disorders, 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 sealed container to protect it from air and light exposure, kept away from direct sunlight, and stored at a temperature between 15°C and 30°C in a cool place.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets