Hecleu Tablet 1 mg (Entecavir)

Adult dose

Administer this medicine orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Administer entecavir 0.5 mg orally once daily. Patients with lamivudine resistance, 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 1 mg 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 50 mL/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 in patients with lamivudine resistance 1 mg once daily Creatinine clearance 30 - <50 mL/min: entecavir dose 0.25 mg a once daily 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 10 - <30 mL/min: entecavir dose 0.15 mg a once daily or 0.5 mg every 72 hours; entecavir dose in patients with lamivudine resistance 0.3 mg a once daily or 1 mg every 72 hours Creatinine clearance <10 mL/min, hemodialysis b or CAPD: entecavir dose 0.05 mg a once daily or 0.5 mg every 7 days; entecavir dose in patients with lamivudine resistance 0.1 mg a once daily or 1 mg every 7 days a: For doses below 0.5 mg, use of the syrup formulation is recommended. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session.

Child dose

Dosage specifically for patients aged 16 and older with lamivudine-resistant strain is separately specified, but no separate dosing regimen for children is mentioned.

This medication can cause serious liver diseases such as lactic acidosis and hepatosteatosis in patients with impaired liver function; therefore, it should be used with caution in cases where there is a risk of liver disease. Discontinuation of treatment can lead to rapid deterioration of hepatitis B, so liver function should be carefully monitored for several months after discontinuing treatment. For patients with HIV and hepatitis B who are not receiving HIV treatment, this medication is not recommended as it may induce HIV treatment resistance. Patients with allergies to this drug or its components, or those with certain genetic issues such as lactose intolerance, should not take this medication. Patients with impaired renal function should adjust the dosage, and patients on hemodialysis should take this medication after dialysis. Liver transplant patients should closely monitor kidney function when used with other medications that may affect kidney function. While taking this medication, side effects such as headache, fatigue, dizziness, and nausea may occur; if symptoms are severe, consult a doctor. It is recommended to take this medication on an empty stomach for higher absorption; taking it with food may reduce absorption. During pregnancy, there may be risks to the fetus; therefore, it should be taken cautiously after consultation with a doctor. If breastfeeding, this medication may be excreted in breast milk, which could affect the baby, so it may be necessary to discontinue either breastfeeding or the drug administration. It can be used by children aged 2 years and older, but safety and effectiveness have not been established for children younger than 2 years. Elderly patients may experience higher drug concentrations due to decreased kidney function; hence, dosage adjustment and kidney function testing are necessary. No specific harmful reactions have been reported for overdose; however, if any unusual symptoms occur, notify medical staff immediately, and if necessary, some can be removed by dialysis. This drug is excreted through the kidneys, so when taken with other medications that affect or compete with kidney function, side effects should be closely monitored. This medication does not affect liver metabolic enzymes, so the likelihood of metabolic interactions with other medications is low; however, caution should be taken regarding kidney function when used with other immunosuppressants in liver transplant patients. During treatment, regular liver function tests should be performed, and if there are abnormalities in liver levels or symptoms, consult a doctor immediately.

Lactic acidosis, steatosis, hepatomegaly, hepatic metabolic dysfunction, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, lightheadedness, drowsiness, insomnia, anaphylactic reactions, increased amino transferases, hair loss, rash, upper abdominal pain, heartburn, cold, cough, pruritus, chest pain, constipation, abdominal pain, back pain, abdominal discomfort, runny nose, intra-abdominal hemorrhage, ascites, portal hypertension associated with gastric disease, 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 prevent exposure to air and moisture, and it is best to keep it in a cool place between 15 to 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP x3)