Entacavir Oral Dispersible Tablet 1 mg (Entacavir)

Adult dose

This drug is administered orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). This drug is an orally disintegrating tablet. Place it on the tongue and allow it to dissolve; it may be taken with or without water. (For orally disintegrating tablets only.) Recommended dosage in adults (16 years and older) The recommended dose is 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 Patients with renal impairment In adults with renal impairment, the oral clearance of this drug decreases as creatinine clearance decreases. In adult patients with creatinine clearance less than 50mL/min, including patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), adjust the dose as shown in Table 2. Table 2 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 drug after the hemodialysis session. (Pharmacokinetic properties in patients with renal impairment: see “8. Administration to patients with renal impairment” under Precautions for Use)

Child dose

Children weighing more than 30kg should receive the 0.5 mg tablet once daily. There are insufficient data to recommend specific dose adjustments for pediatric patients with renal impairment. However, dose reduction or extension of the dosing interval should be considered, similar to dose adjustment in adults.

This medication can cause serious liver problems such as lactic acidosis and fatty liver in patients with impaired liver function; thus, patients at risk for liver disease should exercise caution. Sudden discontinuation of this medication can result in rapid deterioration of hepatitis B, so liver condition should be closely monitored for several months after discontinuation. For patients infected with HIV but not receiving treatment, using this medication alone may lead to HIV resistance, requiring an HIV test before use. Patients with allergies to this medication or its ingredients should not use it. Patients with impaired kidney function, especially those undergoing dialysis, need dose adjustments, and liver transplant recipients should carefully monitor their kidney function. Side effects such as headache, fatigue, dizziness, and nausea may occur during treatment, and if symptoms are severe, consult a doctor. Regular liver function testing is necessary, and medication may be paused if liver levels are abnormally high. During pregnancy, this medication should only be used if absolutely necessary due to potential risks to the fetus, and during breastfeeding, it should be discontinued or breastfeeding should be stopped as the medication may pass into breast milk. This medication is best taken on an empty stomach, as food can reduce absorption. When used with other medications affecting kidney function or excreted through the kidneys, there may be an increased risk of side effects. There is no specific antidote for overdose, thus symptoms should be monitored and appropriate treatment sought as necessary. This medication requires dose adjustments and careful monitoring in children, the elderly, and patients with renal failure, and should be stored out of reach of children and away from direct sunlight.

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

This medication should be stored in a tightly closed container to prevent contact with light and air, and is best stored at room temperature between 1 and 30 degrees Celsius. This storage method helps maintain the medication's effectiveness and prevents degradation.

Appearance

White or pale yellow round oral dispersible tablet

Package unit

30 tablets/box [10 tablets/PTP x 3]