Ilacrud 0.5 mg Tablet (Entecavir)

Adult dose

This medicine should be taken orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Take 0.5mg of entecavir orally once daily. Patients aged 16 years or older with lamivudine resistance, that is, patients who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: 1mg of entecavir orally 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 50mL/min, including those receiving hemodialysis or peritoneal dialysis (CAPD), adjust the dose as follows. 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 below 0.5mg, use of the oral solution is recommended. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session. (Pharmacokinetic properties in patients with renal impairment: refer to “8. Administration to patients with renal impairment” under Precautions for Use)

Child dose

Patients aged 16 years or older should take 1 mg of Entecavir on an empty stomach once daily, same as adults.

Caution is required when administering this drug to patients with liver disease due to the risk of liver function abnormalities and lactic acidosis. If this drug is suddenly discontinued, hepatitis B may deteriorate rapidly, and liver function should be closely monitored for a period after discontinuation. The use of this drug is not recommended for patients co-infected with HIV and hepatitis B who are not receiving HIV treatment; testing for HIV infection is required prior to treatment. This drug and its components should not be administered to patients with allergies to any ingredients or genetic issues such as lactose intolerance. Patients with impaired kidney function or those undergoing dialysis require dosage adjustment, and liver transplant patients must have their kidney function monitored carefully. Side effects such as headache, fatigue, dizziness, and nausea may occur, and immediate consultation with medical staff is required if abnormal liver function test results are found. During pregnancy, this drug should be used cautiously considering the risks to the fetus and its benefits, while during breastfeeding, it is recommended to either stop breastfeeding or discontinue the medication. Taking this drug with food may reduce absorption; it is advisable to take it on an empty stomach. Since this drug is excreted through the kidneys, care should be taken to monitor for adverse reactions when used in conjunction with other drugs that affect kidney function. In case of overdose, standard supportive treatment should be performed and some of the drug may be removed by dialysis. This drug requires caution when used in specific patient populations such as children, elderly, and pregnant women, particularly requiring dosage adjustment and kidney function monitoring in elderly patients with diminished kidney function. This drug should be kept out of reach of children, stored in a cool place away from direct sunlight, and maintained at room temperature.

• Hypersensitivity
• fatty infiltration
• severe liver enlargement
• liver metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• indigestion

This drug is sensitive to air and light, thus it should be stored in a tightly closed container. Additionally, it is advisable to store it in a cool place away from direct sunlight, at a temperature between 15 and 30 degrees Celsius.

Appearance

White to grayish-white triangular film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP*3)]