Entai Tablet 0.5 mg (Entacavir)

Adult dose

This medicine should be administered orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). The dose is 0.5 mg of entecavir orally once daily. Patients with lamivudine resistance, that is, patients 16 years of age or older who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: 1 mg 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. The dose should be adjusted 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: 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 a once daily 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 a once daily or 0.5 mg every 72 hours; entecavir dose in patients with lamivudine resistance 0.3 mg a once daily or 1 mg every 72 hours Creatinine clearance (mL/min) <10, hemodialysis b or CAPD: Entecavir dose 0.05 mg a once daily or 0.5 mg every 7 days; entecavir dose in patients with lamivudine resistance 0.1 mg a once daily or 1 mg every 7 days a: Use of the oral solution is recommended for doses below 0.5mg. 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)

This drug is used for the treatment of chronic hepatitis B, and severe side effects may occur, such as liver dysfunction or lactic acidosis. Patients at risk of liver disease should exercise particular caution. Abrupt discontinuation of this drug can lead to a rapid deterioration of hepatitis B, thus regular monitoring of liver function after stopping therapy is necessary. For patients co-infected with HIV and hepatitis B who are not receiving HIV therapy, the use of this drug is not recommended, so an HIV test should be performed before treatment. Patients with allergies to this drug or its ingredients, or lactose intolerance should not take it, and dose adjustment is necessary for patients with impaired kidney function. Patients who have undergone liver transplants must pay close attention to kidney function before and during treatment with this drug. While taking this medication, symptoms such as headache, fatigue, dizziness, and nausea may occur, and if any abnormalities are found in liver function tests, consultation with a physician should be sought immediately. Taking this medication with food may reduce its absorption, hence it is advisable to take it on an empty stomach. This drug is excreted through the kidneys, so caution is needed when taken with other medications that may affect kidney function. During pregnancy, it should only be used when necessary, considering the risks to the fetus, while nursing mothers should either discontinue breastfeeding or stop taking the medication. Safety and efficacy have only been confirmed for children over 2 years of age; it is not to be used in those under 2. Older adults may require dose adjustments and monitoring of kidney function due to potential decline in renal function. In the case of overdose, there is no specific antidote; appropriate treatment should be based on symptoms, and some of the drug can be removed through hemodialysis. This drug should be stored away from direct sunlight and at room temperature, and kept out of reach of children.

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

This medication should be stored in a tightly closed container to prevent air from entering, ideally at a temperature between 15 degrees and 30 degrees Celsius. This helps maintain its efficacy and prevents deterioration.

Appearance

White to whitish triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP X 3)