Light Entecavir Tablet 1 Milligram (Entecavir)

Adult dose

This medication 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., patients 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 patients with renal impairment, the oral clearance of this medication decreases as creatinine clearance decreases. Adjust the dose as follows in patients with creatinine clearance below 50mL/min, including patients 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 a once daily or 0.5 mg every 48 hours / 0.5 mg once daily or 1 mg every 48 hours 10 - <30 / 0.15 mg a once daily or 0.5 mg every 72 hours / 0.3 mg a once daily or 1 mg every 72 hours <10, hemodialysis b or CAPD / 0.05 mg a once daily or 0.5 mg every 7 days / 0.1 mg a once daily 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 medication after the hemodialysis session. (For pharmacokinetic properties in patients with renal impairment, see “8. Administration to patients with renal impairment” under Precautions for Use.)

Child dose

Administration for pediatric patients under 16 years is not specifically mentioned.

This medication can cause serious liver problems such as lactic acidosis and hepatic steatosis, especially in women with liver disease, so patients with impaired liver function must consult a physician before use. Suddenly stopping this medication can cause a worsening of Hepatitis B, so regular liver function tests should be performed for at least several months after discontinuation of treatment. Patients who are HIV-infected but not yet treated may develop resistance to the medications needed for HIV treatment while using this medication, so an HIV test must be performed prior to use, and this medication is not recommended for those not undergoing HIV treatment. Patients with allergies to this medication or its components, or with certain genetic diseases such as lactose intolerance, should not take this medication. Patients with impaired renal function, especially those undergoing hemodialysis or peritoneal dialysis, need to have their dosage adjusted, and transplant patients should closely monitor renal function when combined with other medications affecting renal function. Side effects such as headache, fatigue, dizziness, and nausea may occur during the treatment, and if symptoms persist, consult a physician. Taking this medication with food could reduce its absorption, so it is best taken on an empty stomach. Pregnant women should use this medication under a doctor's judgment considering the risk to the fetus, and breastfeeding women are recommended to stop breastfeeding or discontinue the medication due to the possibility of excretion into breast milk. Usage is only recommended for children aged 2 years and older, as safety and efficacy have not been established for those under 2. Elderly patients are at a higher risk of renal function decline, so dosage adjustments and monitoring of renal function are necessary. There is no specific antidote for overdose, so symptomatic treatment and supportive care should be provided, and some medications can be removed by hemodialysis. This medication is primarily excreted by the kidneys, so caution is advised when used with other medications that affect renal function, as side effects may occur. This treatment does not reduce the risk of Hepatitis B transmission, so other appropriate measures should continue to be taken for infection prevention. This medication should be stored out of reach of children, away from direct sunlight, and kept in its original packaging.

• Hyperlipidemia
• steatosis
• liver enlargement
• hepatic metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

This medication should be stored in a tightly closed container to prevent air or moisture from entering. The storage temperature should be maintained between 15 degrees to 30 degrees Celsius, and it is advisable to avoid excessively hot or cold places.

Appearance

Pink triangular film-coated tablet

Package unit

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