Entavir Tablet 0.5 mg (Entecavir)

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 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. (Pharmacokinetic properties in patients with renal impairment: see “8. Administration to Patients with Renal Impairment” in Precautions for Use)

Child dose

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

This drug is a nucleoside analog, and serious liver diseases such as severe hepatomegaly, lactic acidosis, and steatosis may occur when used alone or in combination with other antiretroviral agents. Therefore, caution is particularly required in patients with risk factors for liver disease. Abrupt discontinuation of this medication can lead to a rapid worsening of hepatitis B, so liver function must be closely monitored for several months after discontinuation. In patients co-infected with HIV and hepatitis B, this drug is not recommended if HIV treatment is not being received, and HIV infection status must be confirmed prior to use. Patients with allergies to this drug or its components, as well as those with lactose intolerance or certain hereditary metabolic disorders, should not take this medication. Patients with impaired kidney function, especially those on hemodialysis or peritoneal dialysis, will require dosage adjustment, and kidney function should be carefully monitored before and during treatment in liver transplant patients. Side effects such as headache, fatigue, dizziness, and nausea may occur, and various abnormal reactions including liver function test abnormalities, hyperglycemia, and hematuria have been reported, necessitating regular clinical checks and status assessments. Taking this medication with food may decrease its absorption; therefore, it is recommended to take it on an empty stomach. Since this drug is primarily excreted through the kidneys, caution should be exercised when using it in combination with drugs that affect kidney function or compete for renal elimination, as side effects may increase. During pregnancy, it should be used cautiously after considering the risks and benefits to the fetus, and if breastfeeding, it should be decided in consultation with a physician, as the drug may be secreted in breast milk. In children, it is approved for use only in those aged 2 years and older, and safety and efficacy have not been established in those under 2 years of age. Elderly individuals are at higher risk for impaired kidney function, requiring dosage adjustment and renal function monitoring. In the case of overdose, there is no specific antidote, and supportive therapy based on symptoms is necessary. Some drugs may be removed through hemodialysis. This medication may lead to potential resistance development with long-term use, so treatment responses should be periodically assessed, and appropriate actions should be taken if needed.

hepatic steatosis, lipidosis, liver enlargement, hepatic metabolic dysfunction, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, lightheadedness, drowsiness, insomnia, anaphylactic reaction, increased aminotransferase levels, hair loss, rash, upper abdominal pain, heartburn, pruritus, chest pain, constipation, abdominal pain, lower back pain, abdominal discomfort, runny nose, intra-abdominal hemorrhage, ascites, portal hypertension-related gastric disorders, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disorders, gastric angiomatosis, chronic sinusitis, abdominal pain, rash, unpleasant taste, neutropenia

This medication should be stored in a tightly sealed container to keep air out, preferably at room temperature between 15 to 30 degrees Celsius. Storing it this way helps to maintain the drug's effectiveness for a longer period.

Appearance

White to grayish-white triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTPX3)