Entacavir Oral Dissolving Tablet 0.5 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 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. Creatinine clearance (mL/min) ≥ 50: Entecavir dose 0.5 mg once daily; entecavir dose in patients with lamivudine resistance 1 mg once daily Creatinine clearance (mL/min) 30 - <50: Entecavir dose 0.25 mg once daily a 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 (mL/min) 10 - <30: Entecavir dose 0.15 mg once daily a or 0.5 mg every 72 hours; entecavir dose in patients with lamivudine resistance 0.3 mg once daily a or 1 mg every 72 hours Creatinine clearance (mL/min) <10, hemodialysis b or CAPD: Entecavir dose 0.05 mg once daily a or 0.5 mg every 7 days; entecavir dose in patients with lamivudine resistance 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.

Child dose

Children weighing more than 30kg should receive the 0.5 mg tablet once daily.

This drug is used for the treatment of chronic hepatitis B, and special caution is needed for patients with poor liver function or impaired kidney function. During treatment, there may be problems with liver function, and if liver function test results worsen or serious side effects such as lactic acidosis occur, treatment should be stopped immediately. Sudden discontinuation of treatment can worsen hepatitis B, so liver function should be closely monitored for several months after stopping treatment. This medication is not recommended for use in patients with HIV who are not receiving antiretroviral therapy, and it is important to have an HIV test before treatment. Patients with allergies to this drug or its components should not take it, and those with renal failure or who have undergone liver transplant surgery should have their dosage adjusted and kidney function monitored. Side effects such as headache, fatigue, dizziness, and nausea may commonly occur, but most are mild, and the healthcare team should be consulted in case of serious side effects. Taking this medication with food may reduce drug absorption, so it is recommended to take it on an empty stomach. During pregnancy, the risks and benefits to the fetus should be carefully considered before use, and if breastfeeding, one must consider whether to discontinue breastfeeding or the medication as the drug can be secreted in breast milk. Elderly patients or those with impaired kidney function may have increased drug concentration, necessitating dose adjustments and kidney function tests. While there is no specific antidote for overdose, symptoms should be monitored, and if necessary, some of the drug can be removed by dialysis. This drug has been reported to have potential carcinogenicity in some animal studies, such as with liver cancer or lung cancer, but the risk to humans is not clear. Drug interactions are relatively few, but caution is necessary when taking other medications that affect kidney function. To use this drug safely, comply with the prescribed dosage and regimen, undergo regular liver and kidney function tests, and promptly inform medical personnel of any unusual symptoms.

• fatty degeneration
• steatosis
• hepatomegaly
• metabolic dysfunction of the liver
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. It is best to maintain storage temperatures between 1 degree and 30 degrees Celsius.

Appearance

White or light yellow round oral dissolving tablet

Package unit

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