Entacavir Tablet 1.0 mg (Entacavir)

Adult dose

Take this medicine orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Take entecavir 0.5mg orally once daily. Patients resistant to lamivudine, i.e., patients 16 years of age or older who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: entecavir 1mg 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. Adjust the dose as follows in patients with creatinine clearance below 50mL/min, including those receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Creatinine clearance (mL/min) ≥ 50: Entecavir dose 0.5 mg once daily / Entecavir dose in patients resistant to lamivudine 1 mg once daily Creatinine clearance (mL/min) 30 - <50: Entecavir dose 0.25 mg a once daily or 0.5 mg every 48 hours / Entecavir dose in patients resistant to lamivudine 0.5 mg once daily or 1 mg every 48 hours Creatinine clearance (mL/min) 10 - <30: Entecavir dose 0.15 mg a once daily or 0.5 mg every 72 hours / Entecavir dose in patients resistant to lamivudine 0.3 mg a once daily or 1 mg every 72 hours Creatinine clearance (mL/min) <10, hemodialysis b or CAPD: Entecavir dose 0.05 mg a once daily or 0.5 mg every 7 days / Entecavir dose in patients resistant to lamivudine 0.1 mg a once daily 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, take this medicine after the hemodialysis session.

Caution is needed as this drug can cause severe side effects such as serious liver enlargement and lactic acidosis in patients with liver disease, especially women or obese patients. Patients with poor liver function should discontinue use immediately if symptoms of lactic acidosis or signs of liver toxicity appear during treatment. Sudden discontinuation of this medication can lead to an abrupt worsening of hepatitis B, so liver function should be periodically monitored, and the patient's condition should be closely observed even after cessation. Patients co-infected with HIV and hepatitis B are advised not to use this medication alone, and testing for HIV infection is necessary. Patients with allergies to this medication or its components, or those with genetic conditions such as lactose intolerance, should not take it. Patients with impaired kidney function, particularly those undergoing hemodialysis or peritoneal dialysis, should have their dosage adjusted, and liver transplant patients should carefully monitor kidney function. While taking this medication, symptoms such as headache, fatigue, dizziness, nausea, etc., may occur, and liver function test results may increase, so regular testing is needed. It is recommended to take this medication on an empty stomach as food intake can reduce drug absorption. There may be interactions when taken with other renally excreted medications, so it is essential to consult with healthcare providers about any medications being taken. During pregnancy, it should only be used when absolutely necessary due to potential risks to the fetus, and nursing mothers should discontinue breastfeeding or the medication due to the possibility of excretion into breast milk. Use is recommended for children aged 2 years and above; safety and efficacy have not been established for children under 2 years of age. Elderly patients may have increased drug concentrations due to impaired kidney function and require dosage adjustments and kidney function monitoring. There is no specific antidote for overdose, symptoms should be observed, and standard treatment should be applied as necessary, with some removal possible through hemodialysis. The potential carcinogenicity has been reported in animal studies, but the risk in humans is unclear, hence caution is advised during long-term use. Store in a tightly sealed container to prevent air exposure, and keep at room temperature between 15 to 30 degrees Celsius. This storage will maintain drug efficacy and prevent deterioration.

Lactic acidosis, steatosis, liver enlargement, liver metabolic dysfunction, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, lightheadedness, drowsiness, insomnia, anaphylactic reaction, increased aminotransferase enzymes, hair loss, rash, epigastric pain, heartburn, itching, chest pain, constipation, abdominal pain, 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 angiodysplasia, chronic sinusitis, abdominal pain, rash, unpleasant taste, neutropenia

This drug should be stored in a tightly sealed container to prevent air entry, and it is best to store it at room temperature, between 15 and 30 degrees Celsius. This will maintain the drug's effectiveness and prevent deterioration.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTPX3)