Bukwang Entacavir Tablets 1.0 mg (Entacavir Hydrate)

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). Recommended dosage for adults (16 years of age and older) This medicine is administered orally once daily at a dose of 0.5mg of entecavir. Patients with lamivudine resistance, that is, patients 16 years of age and older who have 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 In adult patients with renal impairment, the oral clearance of this medicine decreases as creatinine clearance decreases. The dosage should be adjusted as shown in Table 2 for adult patients with creatinine clearance below 50mL/min, including patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). 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 : Use of the oral solution is recommended for doses less than 0.5mg. b : If administered on a hemodialysis day, this medicine should be administered after the hemodialysis session.

Child dose

Table 1 shows the recommended dose of this drug for pediatric patients aged 2 years and older who weigh at least 10 kg. The syrup should be used only in patients weighing up to 30 kg. 10 to 11 kg inclusive: 3 mL of syrup once daily Over 11 to 14 kg inclusive: 4 mL of syrup once daily Over 14 to 17 kg inclusive: 5 mL of syrup once daily Over 17 to 20 kg inclusive: 6 mL of syrup once daily Over 20 to 23 kg inclusive: 7 mL of syrup once daily Over 23 to 26 kg inclusive: 8 mL of syrup once daily Over 26 to 30 kg inclusive: 9 mL of syrup once daily Over 30 kg: administer 10 mL of syrup or one 0.5 mg tablet once daily. There are insufficient data to recommend a definitive dose adjustment for this drug in pediatric patients with renal impairment; however, similar to dose adjustments in adults, consideration should be given to reducing the dose or extending the dosing interval.

This medication should be used with caution in patients with liver disease, especially as severe liver enlargement and lactic acidosis may occur in women. Patients with liver dysfunction should immediately discontinue use if symptoms of liver toxicity appear while taking this medication. After discontinuation of this medication, acute exacerbation of hepatitis B may occur, thus patients who discontinue treatment should have their liver function closely monitored and resume treatment if necessary. Patients co-infected with HIV and hepatitis B are advised against using this medication alone, and HIV infection should be tested first. Patients with allergies to this medication or its components, or those with genetic issues such as lactose intolerance should avoid use. Patients with diminished kidney function or who are on hemodialysis require dosage adjustment, so they must strictly follow the doctor’s instructions. Patients who have undergone liver transplant surgery should monitor for possible interactions between this medication and immunosuppressants, and renal function and side effects should be carefully observed. This medication is best taken on an empty stomach, as absorption may be reduced when taken with food. Long-term use may cause side effects such as headache, fatigue, dizziness, nausea, thus if symptoms are severe, consultation with a physician is necessary. During pregnancy, it should be used cautiously considering the risk to the fetus, and during breastfeeding, discontinuation of breastfeeding or use of the medication is recommended. For children, use has only been confirmed for those aged 2 and over; safety has not been established for those under 2 years. No special harm has been reported in cases of overdose, but if an overdose occurs, immediate medical attention is necessary. This medication is excreted through the kidneys, hence dosage adjustment and regular monitoring of renal function is needed in patients with diminished kidney function. When storing, keep it out of reach of children, avoid exposure to direct sunlight, and store at room temperature.

• Hyperlactatemia
• Steatosis
• Hepatomegaly
• Hepatic Metabolic Dysfunction
• Headache
• Fatigue
• Dizziness
• Nausea
• Diarrhea
• Dyspepsia

This medication should be stored in a tightly sealed container to avoid exposure to air and light. Additionally, it is best kept in a cool place between 15 to 30 degrees Celsius.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP×3]