Bu-kwang Entacavir Tablet 0.5 mg (Entacavir Hydrate)

Adult dose

This medication should be administered orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Recommended dosage for adults (16 years and older) This medication should be administered orally once daily at a dose of 0.5 mg of entecavir. Patients with lamivudine resistance, that is, patients 16 years and 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 In adults with renal impairment, the oral clearance of this medication decreases as creatinine clearance decreases. For adult patients with creatinine clearance below 50mL/min, including patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), adjust the dose as shown in Table 2. Creatinine clearance (mL/min) ≥ 50: Entecavir dosage 0.5 mg once daily; entecavir dosage in patients with lamivudine resistance 1 mg once daily Creatinine clearance (mL/min) 30 - <50: Entecavir dosage 0.25 mg a once daily or 0.5 mg every 48 hours; entecavir dosage in patients with lamivudine resistance 0.5 mg once daily or 1 mg every 48 hours Creatinine clearance (mL/min) 10 - <30: Entecavir dosage 0.15 mg a once daily or 0.5 mg every 72 hours; entecavir dosage 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 dosage 0.05 mg a once daily or 0.5 mg every 7 days; entecavir dosage in 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 medication after the hemodialysis session.

Child dose

Recommended dose of this medication for pediatric patients aged 2 years or older and weighing at least 10 kg. The syrup formulation should be used only in patients weighing up to 30 kg. Weight 10 to 11 kg: 3 mL of syrup once daily Weight over 11 to 14 kg: 4 mL of syrup once daily Weight over 14 to 17 kg: 5 mL of syrup once daily Weight over 17 to 20 kg: 6 mL of syrup once daily Weight over 20 to 23 kg: 7 mL of syrup once daily Weight over 23 to 26 kg: 8 mL of syrup once daily Weight over 26 to 30 kg: 9 mL of syrup once daily Weight over 30 kg: 10 mL of syrup or one 0.5 mg tablet once daily. Although there are insufficient data to recommend a definitive dose adjustment for pediatric patients with renal impairment, reducing the dose or extending the dosing interval should be considered, similar to dose adjustments in adults.

This medication should be used with particular caution in patients with liver disease. During treatment, lactic acidosis or liver dysfunction may occur; if symptoms appear, treatment should be stopped immediately and consult a physician. Sudden discontinuation of this medication may lead to a rapid worsening of hepatitis B, therefore liver function should be closely monitored for several months even after discontinuation. It is not recommended for patients co-infected with HIV who are not receiving HIV treatment, so an HIV test should be performed before use. Patients with a hypersensitivity to this medication or genetic disorders such as lactose intolerance should not take this medication. Adjustments in dosage are necessary for patients with renal failure or those undergoing dialysis, and liver transplant patients must periodically check kidney function. Common side effects include headache, fatigue, dizziness, nausea, etc., and liver function tests may worsen; regular monitoring is necessary. Taking it with food may decrease the absorption of the drug, so it is recommended to take it on an empty stomach. Close monitoring for adverse reactions is essential when taken with other medications that may affect renal excretion. During pregnancy, it should only be used when necessary due to potential risks to the fetus, and during breastfeeding, it may be excreted in breast milk, so breastfeeding or dosing may need to be discontinued. It is recommended for children aged 2 years and older, with safety and efficacy not established in those under 2 years. Elderly patients may require dosage adjustments and monitoring of kidney function due to decreased kidney function. No specific harm has been reported in case of overdose, but if necessary, it can partly be removed by hemodialysis; immediate consultation with healthcare professionals is necessary in the event of an overdose. This medication should be kept out of reach of children and stored in a tightly closed container away from direct sunlight at room temperature.

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

This medication should be stored in a closed container to protect it from air and light exposure, ideally between 15 and 30 degrees Celsius. This will help maintain the efficacy of the medication for a longer time.

Appearance

White triangular film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP×3]