Entakan Tablet 0.5 mg (Entecavir)

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). Administer 0.5mg of entecavir orally once daily. Patients aged 16 years and older with lamivudine resistance, i.e., those 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: As creatinine clearance decreases in patients with renal impairment, the oral clearance of this medicine 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) ≥ 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 below 0.5mg, use of the oral solution is recommended. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session. (Pharmacokinetic characteristics in patients with renal impairment: Refer to “8. Administration to patients with renal impairment” under Precautions for Use)

Child dose

Patients resistant to lamivudine or those aged 16 years and older should take 1 mg of entecavir orally once a day on an empty stomach.

This medication is used in the treatment of liver disease, and there are several precautions to consider when using it. Firstly, serious liver problems may occur in female patients, especially when this medication is used alone or in combination with other antiretroviral agents, so special caution is needed for patients with compromised liver function. Secondly, discontinuation of this medication may lead to rapid deterioration of hepatitis B, so liver function should be carefully monitored for several months after stopping treatment. Thirdly, this medication is not recommended for patients who are infected with HIV but have not received treatment, and it is important to undergo HIV testing before treatment. Fourthly, individuals allergic to this medication or its ingredients, or certain genetically lactose-intolerant patients should not take this medication. Fifthly, patients with impaired kidney function require dosage adjustments, and particular caution should be taken in patients undergoing dialysis. Sixthly, liver transplant patients should carefully monitor kidney function due to potential interactions with immunosuppressants administered along with this medication. Seventhly, side effects such as headache, fatigue, dizziness, and nausea may occur while taking this medication, and if symptoms are severe, consultation with a physician is necessary. Eighthly, taking this medication with food may reduce its effectiveness, so it is recommended to take it on an empty stomach. Ninthly, the effects on the fetus during pregnancy are unclear, so it should only be used when absolutely necessary, and if breastfeeding, it is recommended to stop breastfeeding or discontinue the medication. Finally, since this medication is excreted through the kidneys, elderly patients with impaired kidney function also require dosage adjustments and monitoring. It is very important to regularly test liver and kidney function while taking this medication and to take it according to the physician’s instructions.

• anemia
• liver metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia
• vomiting
• insomnia

This medication should be stored in a tightly sealed container to prevent air entry, and it is advisable to keep it at room temperature between 15 to 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a long time.

Appearance

White to grayish-white triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)