Dongkwang Entecavir Tablet 0.5mg

Adult dose

This medicine should be taken orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). The recommended dose is 0.5mg of entecavir orally once daily. Patients aged 16 years and older with lamivudine resistance, i.e., patients who have experienced persistent hepatitis B virus replication despite lamivudine treatment or who have lamivudine-resistant mutations: 1mg of entecavir orally once daily on an empty stomach Patients with renal impairment: In patients with renal impairment, the oral clearance of this medicine decreases as creatinine clearance decreases. For patients with creatinine clearance <50mL/min, including those receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), adjust the dose as follows. Creatinine clearance (mL/min) ≥ 50: Entecavir dose 0.5 mg once daily; entecavir dose for patients with lamivudine resistance 1 mg once daily Creatinine clearance (mL/min) 30 - <50: Entecavir dose 0.25 mg a once daily or 0.5 mg every 48 hours; entecavir dose for 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 a once daily or 0.5 mg every 72 hours; entecavir dose for patients with lamivudine resistance 0.3 mg a once daily or 1 mg every 72 hours Creatinine clearance (mL/min) <10, hemodialysis b or CAPD: Entecavir dose 0.05 mg a once daily or 0.5 mg every 7 days; entecavir dose for patients with lamivudine resistance 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 medicine 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

Indicated for patients aged 16 years and older who are resistant to lamivudine; no specific dosage is available for children under 16 years.

This medication can lead to serious side effects such as lactic acidosis and lipodystrophy in patients with impaired liver function or those with risk factors for liver disease, so caution is advised. Abrupt discontinuation of this medication can severely exacerbate hepatitis B, so liver function should be closely monitored for several months after stopping. This medication is not recommended for HIV and hepatitis B co-infected patients who are not receiving treatment for HIV, and HIV status should be tested prior to administration. Patients with allergic reactions to this medication or its ingredients, as well as those with specific genetic lactose intolerance, should not use it. Dosing adjustments are necessary for patients with renal impairment or those undergoing hemodialysis, and careful monitoring of renal function is required for liver transplant patients. Side effects such as headache, fatigue, dizziness, nausea, and others may occur, so if any abnormal symptoms arise, patients should consult healthcare professionals. Taking this medication with food may reduce absorption, so it is preferable to take it on an empty stomach. During pregnancy, it should only be used if necessary due to potential risks to the fetus, and nursing mothers are advised to stop breastfeeding or discontinue the medication. Use in children is only approved for those over the age of 2, and safety and efficacy have not been established for children under 2. Elderly patients or those with decreased renal function may have higher drug concentrations, thus requiring dosing adjustments and renal monitoring. There are no specific antidotes for overdose, so symptomatic supportive care should be provided, and some removal may occur through hemodialysis. This medication may interact with other drugs, so especially when taken with medications that affect renal function, healthcare professionals should be informed. Regular liver function testing should be conducted during treatment, and if any abnormal signs are found, immediate consultation with healthcare professionals is necessary. This medication does not reduce the risk of infectivity for hepatitis B, so appropriate measures for infection prevention should continue.

• Lactic acidosis
• steatosis
• hepatomegaly
• hepatic metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

This medication should be stored in a tightly closed container to protect it from air and light. It is best to keep it at a temperature between 15 to 30 degrees Celsius to maintain its effectiveness.

Appearance

White to off-white triangular shaped film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP × 3)]