Entacavir Tablets 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). Recommended dosage for adults (16 years and older) Administer 0.5mg of entecavir orally once daily. Patients with lamivudine resistance, i.e., patients 16 years 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 adults with renal impairment, the oral clearance of this medicine decreases as creatinine clearance decreases. In adult patients with creatinine clearance <50mL/min, including those receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), adjust the dosage as shown in Table 2. Creatinine clearance ≥ 50 mL/min: entecavir dose 0.5 mg once daily; entecavir dose in patients with lamivudine resistance 1 mg once daily Creatinine clearance 30 - <50 mL/min: 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 10 - <30 mL/min: 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 <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.

Child dose

Recommended dosage for pediatric patients Recommended dosage of this medicine for pediatric patients aged 2 years and older and weighing at least 10kg. The oral solution should be used only in patients weighing up to 30kg. Body weight 10 to 11 kg: recommended oral solution dose once daily 3 mL Body weight >11 to 14 kg: recommended oral solution dose once daily 4 mL Body weight >14 to 17 kg: recommended oral solution dose once daily 5 mL Body weight >17 to 20 kg: recommended oral solution dose once daily 6 mL Body weight >20 to 23 kg: recommended oral solution dose once daily 7 mL Body weight >23 to 26 kg: recommended oral solution dose once daily 8 mL Body weight >26 to 30 kg: recommended oral solution dose once daily 9 mL Body weight >30 kg: administer 10 mL of the oral solution or one 0.5 mg tablet once daily. There are insufficient data to recommend a specific dosage adjustment for pediatric patients with renal impairment. However, consideration should be given to reducing the dose or extending the dosing interval, similarly to the dosage adjustment in adults.

This drug is an antiviral agent used for the treatment of chronic hepatitis B, and special caution is needed for patients with severely impaired liver function or decreased kidney function. Serious liver-related side effects, such as lactic acidosis and hepatic steatosis, may occur during treatment, so if these symptoms appear, immediately stop taking the medication and consult with a healthcare professional. Sudden discontinuation of treatment may lead to rapid deterioration of hepatitis B, so when stopping the medication, liver function should be monitored and managed regularly according to the physician's instructions. This drug may induce resistance to HIV treatment when used alone in patients with HIV infection, so HIV status must be confirmed before use, and it is not recommended for patients not receiving HIV therapy. Patients with lactose intolerance or specific genetic metabolic disorders should not take this drug, and those with allergic reactions should also avoid taking it. Patients with renal impairment may require dose adjustments, and particularly those undergoing hemodialysis or peritoneal dialysis must strictly follow the physician's instructions regarding timing and dosage. Liver transplant patients or those taking immunosuppressants that may affect kidney function should closely monitor their kidney function before and during the use of this drug. It is advisable to take this medication on an empty stomach, as absorption may decrease when taken with food. During pregnancy, caution should be exercised considering the potential risks to the fetus, and in the case of breastfeeding, it is recommended to either discontinue breastfeeding or stop taking the medication, as it may be excreted in breast milk. For children, it can be used in those aged 2 years and older. Its safety and efficacy in those younger than 2 years have not been established, and thus it is not recommended. Elderly patients are at an increased risk of decreased kidney function, so dosage adjustment and kidney function testing are required. In case of overdose, there is no specific antidote available, and supportive care should be provided according to symptoms; some drugs can be removed through hemodialysis. While taking this medication, side effects such as headache, fatigue, dizziness, and nausea may occur; severe side effects should be reported to healthcare professionals immediately. This medication may interact with other medicines, so especially when taken simultaneously with drugs that affect renal excretion, consultation with healthcare professionals is necessary. Finally, this drug should be stored out of reach of children, away from direct sunlight, and at room temperature.

• Lactic acidosis
• fatty liver
• hepatomegaly
• hepatic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

This medication is sensitive to light and should be stored in a tightly sealed container that does not allow light to enter. The storage temperature should be suitable in a cool place between 15 to 30 degrees Celsius.

Appearance

White or nearly white, triangular film-coated tablet

Package unit

30 tablets/box (10 tablets/PTP x 3)