Entazene Tablets 0.5mg (Entecavir)

Adult dose

Take this medicine orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Take 0.5mg of entecavir orally once daily. Patients with lamivudine resistance, i.e., patients 16 years of age and older who have experienced persistent hepatitis B virus replication despite lamivudine treatment or who have lamivudine-resistance mutations: 1mg of entecavir once daily on an empty stomach Patients with renal failure: In patients with renal failure, the oral clearance of this medicine decreases as creatinine clearance decreases. Adjust the dose as follows in patients with creatinine clearance below 50mL/min, including those receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Creatinine clearance (mL/min) | Entecavir dose | Entecavir dose in patients with lamivudine resistance ≥ 50 | 0.5 mg once daily | 1 mg once daily 30 - <50 | 0.25 mg once daily a or 0.5 mg every 48 hours | 0.5 mg once daily or 1 mg every 48 hours 10 - <30 | 0.15 mg once daily a or 0.5 mg every 72 hours | 0.3 mg once daily a or 1 mg every 72 hours <10, hemodialysis b or CAPD | 0.05 mg once daily a or 0.5 mg every 7 days | 0.1 mg once daily a or 1 mg every 7 days a: For doses less than 0.5mg, use of the syrup formulation is recommended. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session. (Pharmacokinetic characteristics in patients with renal failure: See “8. Administration to patients with renal failure” under Precautions for Use.)

This medication is primarily an antiviral used in the treatment of chronic hepatitis B. Caution is necessary when this drug is used alone or in conjunction with other antiretrovirals, especially in women, obese patients, and patients who have used nucleoside analogs for prolonged periods, as it may cause lactic acidosis and severe hepatomegaly with hepatic steatosis. Patients with impaired liver function are at higher risk for lactic acidosis, and if liver function abnormalities are found while using this medication, it should be discontinued immediately. Additionally, abrupt discontinuation of this medication may lead to a rapid deterioration of hepatitis B, so liver function should be closely monitored for several months after cessation, and treatment should be resumed if necessary. This drug is not recommended for patients co-infected with HIV who are not receiving HIV treatment, and it is important to take an HIV test prior to treatment. Patients with hypersensitivity to this drug or with certain genetic metabolic disorders such as lactose intolerance should not be administered this drug. Patients with renal failure or those undergoing hemodialysis require dosage adjustments, and liver transplant recipients should have their kidney function monitored carefully. Common side effects of this drug include headache, fatigue, dizziness, nausea, and regular liver function tests are needed as liver enzyme levels may rise. During pregnancy, the risks and benefits to the fetus must be carefully weighed, and nursing mothers should ideally discontinue breastfeeding or the medication. This medication should be taken on an empty stomach for optimal absorption, and there is low interaction with other medications but caution is needed when used with drugs affecting kidney function. In cases of overdose, the patient should be monitored and supportive care provided if necessary, as some of the drug can be removed by hemodialysis. Certain patient groups like children, the elderly, or pregnant women may require careful dose adjustments, and the medication should be stored in a cool, dry place out of the reach of children.

• Liver dysfunction
• steatosis
• hepatomegaly
• metabolic liver dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• indigestion

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture. Additionally, it is important to store it at room temperature, between 15°C and 30°C. This will help maintain the drug's effectiveness and prevent deterioration.

Appearance

White to grayish-white triangular film-coated tablets

Package unit

- - 30 tablets/PTP [10 tablets/PTP × 3]