Entaclude Tablet 1.0 mg (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.

Child dose

The dosage for patients over 16 years of age is specified separately, but no specific dosage information is provided for children under 16.

This drug is primarily used for the treatment of chronic hepatitis B. The most important caution while taking this drug is the risk of severe liver problems, such as lactic acidosis and hepatic steatosis. This risk is especially higher in women, obese individuals, and patients who have used nucleoside analogs for an extended period. Patients with poor liver function are at increased risk of lactic acidosis while taking this drug; if symptoms of liver dysfunction appear, the medication should be temporarily discontinued. Moreover, sudden cessation of this drug can lead to a rapid deterioration of hepatitis B; hence, when discontinuing treatment, liver function should be consistently monitored and managed under the physician's guidance. This drug is not recommended for patients infected with HIV who are not receiving antiretroviral therapy. An HIV test is necessary before treatment. Patients allergic to this drug or its components should not take it, and those with genetic issues such as lactose intolerance should also avoid its use. Patients with decreased kidney function or those undergoing dialysis require dose adjustment, and patients who have undergone liver transplantation must carefully monitor their kidney function. The most common side effects of this drug include headache, fatigue, dizziness, nausea, and abnormal liver function tests. If symptoms of hepatitis worsen or liver enzyme levels significantly rise during treatment, immediate consultation with a physician is required. This drug should be taken on an empty stomach as its absorption may be reduced when taken with food. During pregnancy, it should only be used when absolutely necessary, considering the risk to the fetus, and breastfeeding should be stopped or the medication discontinued while nursing. This medication is only suitable for children aged 2 years and older; safety and efficacy in children under 2 years have not been established. Elderly individuals may have decreased kidney function, so caution is necessary, and doses should be adjusted based on kidney function tests. This drug is excreted by the kidneys; hence, caution is advised when taken with other medications that may affect kidney function, as adverse reactions may occur. In case of overdose, no specific antidote exists, so appropriate treatment and monitoring based on symptoms is necessary. Finally, this drug should be stored out of the reach of children, protected from direct sunlight, and stored at room temperature.

hyperlipidemia, fatty liver, hepatomegaly, hepatic metabolic dysfunction, headache, fatigue, dizziness, nausea, diarrhea, indigestion, vomiting, vertigo, drowsiness, insomnia, anaphylactic reaction, increased aminotransferases, hair loss, rash, upper abdominal pain, heartburn, chest pain, cold, itching, constipation, abdominal pain, low back pain, abdominal discomfort, runny nose, intra-abdominal 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 drug should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is important to keep it at a cool temperature between 15 degrees and 30 degrees Celsius to maintain its effectiveness.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)