Entacavir Tablets 1 mg (Entacavir)

Adult dose

Take this medicine orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Recommended dose for adults (16 years and older) Administer entecavir 0.5mg orally once daily. Patients resistant to lamivudine, i.e., patients 16 years of age and older who have experienced persistent hepatitis B virus replication despite lamivudine treatment or have lamivudine-resistant mutations: entecavir 1mg once daily on an empty stomach Patients with renal impairment Creatinine clearance (mL/min) ≥ 50: 0.5 mg once daily; entecavir dose for patients resistant to lamivudine: 1 mg once daily Creatinine clearance (mL/min) 30 - <50: 0.25 mg a once daily or 0.5 mg every 48 hours; entecavir dose for patients resistant to lamivudine: 0.5 mg once daily or 1 mg every 48 hours Creatinine clearance (mL/min) 10 - <30: 0.15 mg a once daily or 0.5 mg every 72 hours; entecavir dose for patients resistant to lamivudine: 0.3 mg a once daily or 1 mg every 72 hours Creatinine clearance (mL/min) <10, hemodialysis b or CAPD: 0.05 mg a once daily or 0.5 mg every 7 days; entecavir dose for patients resistant to lamivudine: 0.1 mg a once daily or 1 mg every 7 days a: For doses less than 0.5mg, use of the syrup is recommended. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session.

Child dose

Recommended dose of this medicine for pediatric patients aged 2 years and older weighing at least 10kg. The syrup is for use only in patients weighing up to 30kg. 10 to 11 kg: Recommended once-daily syrup dose 3 mL Over 11 to 14 kg: Recommended once-daily syrup dose 4 mL Over 14 to 17 kg: Recommended once-daily syrup dose 5 mL Over 17 to 20 kg: Recommended once-daily syrup dose 6 mL Over 20 to 23 kg: Recommended once-daily syrup dose 7 mL Over 23 to 26 kg: Recommended once-daily syrup dose 8 mL Over 26 to 30 kg: Recommended once-daily syrup dose 9 mL Over 30: Recommended once-daily syrup dose 10 mL a Children weighing more than 30kg may receive 10 mL of syrup or one 0.5 mg tablet once daily. Data are insufficient to recommend specific dose adjustments for pediatric patients with renal impairment. However, consider reducing the dose or extending the dosing interval, similar to dose adjustment in adults.

This medication is an antiviral agent used in the treatment of chronic hepatitis B. Lactic acidosis and fat accumulation may occur during the use of this drug, particularly reported more frequently in women. Caution should be taken as patients who are obese or have used nucleoside analogs for a long time are at higher risk. Patients with decreased liver function may have an increased risk of lactic acidosis during treatment with this drug, so immediate discontinuation should occur if liver dysfunction is detected. Sudden discontinuation of this drug may lead to a rapid worsening of hepatitis B, so liver function should be closely monitored for several months upon cessation of therapy. In patients co-infected with HIV and hepatitis B who are not receiving effective HIV treatment, the use of this drug is not recommended. Patients with allergies to this drug or its components should not take it, and patients with lactose intolerance or related genetic disorders should also not be administered. Patients with impaired kidney function, especially those undergoing hemodialysis or peritoneal dialysis, may require dose adjustments, and kidney function in liver transplant patients should be carefully monitored. Common side effects may include headache, fatigue, dizziness, nausea, and it is advisable to consult a doctor if abnormal liver function test results arise. This drug should be taken on an empty stomach, as absorption may be reduced with food. During pregnancy, the risks and benefits to the fetus should be carefully considered, and breastfeeding should be stopped or this medication discontinued while nursing. The safety and efficacy of this drug have only been confirmed in children aged 2 years and older; it is not recommended for children under the age of 2. In the case of overdose, there is no specific antidote, so appropriate supportive treatment should be initiated depending on symptoms, and some may be removed by hemodialysis. This drug is excreted through the kidneys; caution is advised as it may interact with other medications that affect kidney function, potentially increasing side effects. Store this medication out of reach of children, protecting it from direct sunlight and keeping it at room temperature; syrup forms should be used within the specified expiration date even after opening.

Hyperlactacidemia, fatty liver, hepatomegaly, hepatic metabolism dysfunction, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, vertigo, drowsiness, insomnia, anaphylactic reactions, increased aminotransferase, hair loss, rash, abdominal pain, heartburn, chest pain, cold, cough, itching, constipation, abdominal cramps, lower back pain, abdominal discomfort, runny nose, abdominal pain, papules, urticaria, fever, upper respiratory infection, gastroenteritis, H1N1 influenza, lower limb fractures, upper limb fractures, influenza-like symptoms, bronchitis, folliculitis, eczema, seborrheic dermatitis, ligament sprain, influenza, intra-abdominal hemorrhage, ascites, portal hypertension-related gastric disease, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disorders, gastric hemangioma, chronic sinusitis, neutropenia, abdominal pain, bad taste, hematuria

This medication is sensitive to light, and should be stored in a tightly sealed container that does not allow light to pass through. A cool place with a temperature between 15 and 30 degrees Celsius is suitable for storage.

Appearance

Pink triangular film-coated tablets

Package unit

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