Kebiran Tablet 1mg (Entacavir)

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 0.5mg orally once daily. Patients with lamivudine resistance, i.e., patients aged 16 years or older who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: Administer entecavir 1mg orally once daily on an empty stomach. Patients with renal failure: In patients with renal failure, the oral clearance of this medicine decreases as creatinine clearance declines. 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 medicine after the hemodialysis session. (See “8. Administration to patients with renal failure” under Precautions for use for pharmacokinetic properties in patients with renal failure.)

Child dose

No specific dosage is indicated for patients under 16 years of age.

This drug can cause severe liver problems such as lactic acidosis and steatosis in patients with liver disease, so extra precautions should be taken if there are any liver health issues. Discontinuation of treatment may lead to a rapid deterioration of hepatitis B, so liver function should be monitored consistently according to the physician's instructions when stopping treatment. This drug is not recommended for patients with HIV infection, and it is important to undergo HIV testing before treatment. It should not be used if there is a known allergy to this drug or its ingredients, and patients with certain genetic conditions like lactose intolerance should also avoid it. Patients with decreased kidney function require dose adjustments, and liver transplant patients should closely monitor kidney function. Side effects such as headache, fatigue, dizziness, and nausea may occur, and if symptoms are severe, consultation with a physician is necessary. Since this medication is primarily excreted through the kidneys, caution is needed when taken with other drugs that impair kidney function. Pregnant women should carefully consider the risks to the fetus and the benefits of this drug before use, and nursing mothers are advised to either stop breastfeeding or discontinue the medication. Children and elderly patients should also be cautious when using this drug, and in particular, dosage adjustments may be necessary for the elderly due to reduced kidney function. No specific harm has been reported in cases of overdose, but if an overdose occurs, observation and support from healthcare professionals are required. When storing, keep the drug out of reach of children, avoid direct sunlight, and store it at the prescribed temperature.

Liver dysfunction, fatty liver, hepatomegaly, metabolic liver dysfunction, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, lightheadedness, drowsiness, insomnia, anaphylactic reaction, increase in aminotransferases, hair loss, rash, upper abdominal pain, heartburn, chest pain, cold, cough, itching, constipation, abdominal pain, back pain, abdominal discomfort, runny nose, intra-abdominal bleeding, ascites, portal hypertension with gastrointestinal disease, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disease, gastric angiofibroma, chronic sinusitis, abdominal pain, bad taste, neutropenia

This medication should be stored in a tightly closed container to prevent exposure to air and light, and it is advisable to store it at room temperature between 15 to 30 degrees Celsius. Proper storage will maintain the medication's effectiveness and prevent degradation.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTPX3)