Encarbis 1 mg Tablets (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. 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) ≥ 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 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

There is a dosage for patients over 16 years of age who are resistant to lamivudine; however, there is no specific dosage mentioned for those under 16 years.

This drug can cause serious side effects such as lactic acidosis and hepatic steatosis in patients with impaired liver function; hence, caution is particularly necessary for patients at risk of liver disease. Sudden discontinuation of this medicine may lead to rapid worsening of hepatitis B, so liver function must be closely monitored for several months after discontinuation. In patients with concurrent HIV and hepatitis B infections who are not receiving HIV treatment, the use of this drug is not recommended, and testing for HIV infection is required before administration. Patients with allergies to this drug or any of its components, as well as those with certain genetic metabolic disorders like lactose intolerance, should not take this medication. Dose adjustment may be necessary for patients with reduced kidney function or those undergoing dialysis, and careful monitoring of kidney function should be done for patients who have received a liver transplant. This drug contains Yellow No. 5 coloring agent, and patients with allergies to this component should use it cautiously. During administration, side effects such as headache, fatigue, dizziness, nausea, etc., may occur; if abnormal liver function test results are found, consult a physician immediately. Taking it with food may decrease drug absorption, so it is recommended to take on an empty stomach. This drug is excreted through the kidneys, so when used with drugs that affect kidney function or hinder renal excretion, closely monitor for side effects. During pregnancy, it should only be used when necessary due to potential risks to the fetus; during breastfeeding, it is advisable to either discontinue breastfeeding or the medication. In pediatric patients, use is recommended only for those aged 2 years and older, as safety and effectiveness have not been established in those under 2 years. In the elderly, adjustment of dosage and monitoring of kidney function may be required due to possible reduced kidney function. In case of overdose, there is no specific antidote, so appropriate supportive care should be received based on symptoms, and some drugs may be removed by dialysis. This medication should be kept out of reach of children, away from direct sunlight, and stored at the prescribed temperature.

Lactic acidosis, steatosis, hepatomegaly, hepatic metabolic dysfunction, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, lightheadedness, drowsiness, insomnia, anaphylactic reaction, elevated aminotransferases, hair loss, rash, upper abdominal pain, heartburn, pruritus, chest pain, constipation, abdominal pain, lower back pain, abdominal discomfort, runny nose, hematuria, thrombocytopenia, hyperglycemia, diabetes, hepatic neoplasm, intra-abdominal hemorrhage, ascites, portal hypertension gastrointestinal syndrome, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disease, gastric hemangioma, chronic sinusitis, abdominal pain, rash, unpleasant taste, neutropenia

This medicine should be stored in a tightly sealed container to prevent air from entering, ideally in a cool place between 15 degrees and 30 degrees Celsius. This way of storage helps maintain the drug's effectiveness for a longer time.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP) X 3