Enluvid 0.5 mg (Entecavir Hydrate)

Adult dose

Take this medicine orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). The recommended dose is 0.5mg of entecavir once daily by mouth. Patients with lamivudine resistance, i.e., patients 16 years of age or older who experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: 1mg of entecavir once daily on an empty stomach Patients with renal impairment: As creatinine clearance decreases in patients with renal impairment, the oral clearance of this medicine decreases. Adjust the dose as follows in patients with creatinine clearance below 50mL/min, including those receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Creatinine clearance (mL/min) ≥ 50: 0.5 mg once daily; entecavir dose for patients with lamivudine resistance: 1 mg once daily 30 - <50: 0.25 mg a once daily or 0.5 mg every 48 hours; entecavir dose for patients with lamivudine resistance: 0.5 mg once daily or 1 mg every 48 hours 10 - <30: 0.15 mg a once daily or 0.5 mg every 72 hours; entecavir dose for patients with lamivudine resistance: 0.3 mg a once daily or 1 mg every 72 hours <10, hemodialysis b or CAPD: 0.05 mg a once daily or 0.5 mg every 7 days; entecavir dose for patients with lamivudine resistance: 0.1 mg a once daily or 1 mg every 7 days a : For doses below 0.5mg, use of the syrup formulation is recommended. b : If administered on a hemodialysis day, administer this medicine after the hemodialysis session.

Child dose

For patients aged 16 years and older, administer 1 mg orally once a day on an empty stomach, in the same manner as patients with lamivudine-resistant infections.

This medication may cause serious side effects such as lactic acidosis and fatty liver in patients with liver disease, therefore caution is particularly needed in women and obese patients. Patients with impaired liver function are at higher risk for lactic acidosis and should have their liver function monitored regularly, and treatment should be temporarily suspended if any abnormal symptoms occur. Abrupt cessation of this medication may cause acute exacerbation of Hepatitis B, so liver function should be closely monitored for several months after discontinuation. Patients co-infected with HIV and Hepatitis B should not use this medication alone, and treatment should start only after confirming the HIV infection status. Patients with allergy to this medication or its components, or specific genetic metabolic disorders such as lactose intolerance should not use this medication. Patients with impaired kidney function, especially those undergoing hemodialysis or peritoneal dialysis, require dosage adjustments, and liver transplant patients need to be closely monitored for kidney function. Side effects such as headache, fatigue, dizziness, nausea, may occur, so if any unusual symptoms appear, consultation with medical personnel is necessary. If abnormal liver function testing results appear during treatment, it may be necessary to adjust therapy, and periodic testing is important due to the risk of hepatitis exacerbation. This medication is recommended to be taken on an empty stomach as absorption may decrease when taken with food. Since it is primarily excreted via the kidneys, the risk of side effects may increase when used in combination with other medications that affect kidney function, and in such cases, patient status should be closely observed. During pregnancy, this medication should only be used when essential, considering the risk to the fetus, and during breastfeeding, it is recommended to either stop breastfeeding or discontinue the medication. In pediatric patients, it can be used from the age of 2 years and safety and efficacy have not been established in those younger than 2 years. Elderly patients are at a higher risk of declining kidney function, so dosage adjustments and monitoring of kidney function are necessary. In case of overdose, there are no specific antidotes, and appropriate supportive care should be provided depending on symptoms, and some removal may occur through hemodialysis. Store this medication in a tightly closed container away from light and out of reach of children.

• Jaundice
• fatty liver
• hepatomegaly
• liver metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

This medication is sensitive to light, so it should be stored in a sealed container that does not allow light to enter. It is important to maintain a storage temperature between 15 degrees and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness over time.

Appearance

White to grayish-white triangular film-coated tablet

Package unit

30 tablets/PTP