Ilacrud 1.0 mg Tablet (Entacavir)

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 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) ≥ 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 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 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

This medication should be used with caution in patients with compromised liver function or those at risk for liver disease, as serious side effects such as lactic acidosis and steatosis may occur. Abrupt discontinuation of this medication can lead to rapid deterioration of hepatitis B, necessitating close monitoring of liver function for at least several months after discontinuation. For patients coinfected with HIV and hepatitis B who are not undergoing HIV treatment, the use of this medication is not recommended, and an HIV test is required prior to treatment. Patients with allergies to this medication or its ingredients, as well as those with certain genetic metabolic disorders such as lactose intolerance, should not be administered this medication. In patients with impaired kidney function, particularly those receiving hemodialysis or peritoneal dialysis, dose adjustments are necessary, and liver transplant recipients should be closely monitored for renal function. It is recommended to take this medication on an empty stomach, as food may reduce absorption. During treatment, side effects such as headache, fatigue, dizziness, nausea may occur; if any unusual symptoms arise, patients should consult with a physician. Regular liver function tests and other clinical assessments should be conducted to monitor for hepatotoxicity or adverse reactions. During pregnancy, there may be risks to the fetus, so it should only be used when absolutely necessary, and breastfeeding should be halted or dosing stopped if breastfeeding. This medication is approved for use in children 2 years and older, and its safety and efficacy have not been established in children under 2 years. As this medication is primarily excreted by the kidneys, caution is necessary when used in combination with other medications that may affect kidney function, as the risk of adverse effects may increase. In the case of overdose, there is no specific antidote, and immediate medical attention should be sought for appropriate supportive care. Keep out of reach of children, and store in a cool place away from direct sunlight.

Liver steatosis, fatty liver, hepatic hypertrophy, impaired liver metabolism, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, vertigo, drowsiness, insomnia, anaphylactic reactions, increased aminotransferases, hair loss, rash, epigastric pain, heartburn, itching, cold, cough, chest pain, constipation, abdominal pain, low back pain, abdominal discomfort, runny nose, intraperitoneal hemorrhage, ascites, portal hypertension related gastrointestinal disease, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disease, gastric vascular tumors, chronic sinusitis, abdominal pain, rash, bad taste, neutropenia

This medication should be stored in a tightly closed container to protect it from air and light exposure. It is recommended to keep it in a cool place, between 15 to 30 degrees Celsius. This storage method helps maintain the medication's effectiveness for a longer period.

Appearance

Pink triangular film-coated tablet

Package unit

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