Myungmoon Entecavir Tablet 0.5mg

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 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 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. Adjust the dose as follows in patients with creatinine clearance below 50 mL/min, including patients receiving hemodialysis or peritoneal dialysis (CAPD). 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: Use of the syrup formulation is recommended for doses less than 0.5 mg. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session. (Pharmacokinetic properties in patients with renal impairment: See ‘8. Administration to patients with renal impairment’ under Precautions for Use.)

Child dose

For patients over 16 years of age with lamivudine-resistant virus, entecavir should be administered 1 mg orally once daily on an empty stomach.

This drug is used for the treatment of chronic hepatitis B and requires special attention in patients with poor liver function or impaired kidney function. Serious side effects such as lactic acidosis or liver dysfunction may occur with this medication, thus regular liver function tests should be performed during treatment. If antiviral therapy is suddenly discontinued, hepatitis may rapidly worsen; therefore, it should be taken continuously according to the doctor's instructions, and liver function should be closely monitored upon discontinuation. In patients co-infected with HIV and hepatitis B who are not receiving HIV treatment, this medication may lead to resistance against HIV drugs, and HIV infection status should be confirmed prior to use. This medication contains lactose and should not be taken by patients with lactose intolerance or related genetic disorders. Patients with renal failure or those undergoing dialysis should adjust the dosage of this medication, and liver transplant patients should closely monitor kidney function when used in conjunction with immunosuppressants. It is recommended to take this medication on an empty stomach, as food may decrease its absorption. Common side effects include headache, fatigue, dizziness, and nausea, but most are mild. During pregnancy, it should be administered only after consultation with a doctor due to potential risk to the fetus, and it is recommended to stop breastfeeding or discontinue this medication while nursing. This drug is primarily excreted through the kidneys, so when used with other medications that may affect kidney function, side effects should be closely monitored. In the case of overdose, there is no specific antidote, and appropriate supportive treatment should be received according to symptoms; some removal may be possible via dialysis. This medication can be used in various patient groups, including children, elderly patients, and patients with liver failure, but dosage adjustment and caution are necessary based on age and kidney function. Store this medication out of the reach of children, avoid direct sunlight, and store it at room temperature.

• Lactic acidosis
• liver metabolism dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• indigestion
• vomiting
• vertigo

This medication should be stored in a tightly closed container to protect it from air and light exposure, and it is best stored in a cool place, that is between 15 to 30 degrees Celsius, away from direct sunlight.

Appearance

White triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP X 3)