Heklur Tablet 0.5 mg (Entecavir)

Adult dose

Administer this medicine orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Administer 0.5 mg of entecavir orally once daily. Patients aged 16 years or older with lamivudine resistance, that is, patients who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: 1 mg of entecavir 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. Adjust the dose as follows in patients with creatinine clearance below 50 mL/min, including patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). ≥ 50 mL/min: Entecavir dose 0.5 mg once daily; entecavir dose in patients with lamivudine resistance 1 mg once daily 30 - <50 mL/min: Entecavir dose 0.25 mg a once daily 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 10 - <30 mL/min: Entecavir dose 0.15 mg a once daily or 0.5 mg every 72 hours; entecavir dose in patients with lamivudine resistance 0.3 mg a once daily or 1 mg every 72 hours <10 mL/min, hemodialysis b or CAPD: Entecavir dose 0.05 mg a once daily or 0.5 mg every 7 days; entecavir dose in patients with lamivudine resistance 0.1 mg a once daily or 1 mg every 7 days a: For doses less than 0.5 mg, 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: Refer to “8. Administration to Patients with Renal Impairment” under Precautions for Use)

Child dose

Dosage is specified for patients resistant to lamivudine or patients aged 16 years and older, but a separate dosage regimen for children under 16 years of age is not mentioned.

This medicine should be used with caution in patients with liver disease. When nucleoside analogs are used alone or in combination with other antiviral agents, rare but serious lactic acidosis and hepatic steatosis may occur, primarily reported in women. Patients with impaired liver function are at higher risk of lactic acidosis, so if signs of liver dysfunction occur, the medication should be stopped immediately. Sudden discontinuation of this medication may seriously worsen hepatitis B, so regular liver function tests should continue for a certain period after discontinuation. In patients co-infected with HIV and hepatitis B who are not receiving HIV treatment, it is advisable not to use this medication, and HIV infection status must be confirmed before treatment. Patients with allergies to this medication or its components, as well as those with genetic metabolic disorders like lactose intolerance, should not take this medication. Patients with reduced kidney function or those on dialysis require dose adjustments, and for liver transplant patients, kidney function should be monitored carefully. The most common side effects of this medication include headache, fatigue, dizziness, nausea, and regular liver function tests are necessary as there may be an increase in liver function test values. During pregnancy, the risks and benefits to the fetus should be carefully considered before using this medication, and if breastfeeding, it is recommended to either stop breastfeeding or discontinue the medication. Taking this medication with food may reduce drug absorption, so it is advised to take it on an empty stomach. Since it is primarily excreted through the kidneys, caution is required when using it with other medications that may affect kidney function, as side effects may occur. There is no specific treatment for overdose, so it is important to observe symptoms and receive supportive care if needed. Special populations, such as children, the elderly, and pregnant women, require careful dosing and monitoring, especially elderly patients with reduced kidney function. This medication should be kept out of the reach of children, stored in a tightly sealed container protected from direct sunlight, and kept at room temperature. During the course of this medication, routine liver and kidney function tests should be conducted, and if any abnormal symptoms occur, medical attention should be sought immediately.

• Lactic acidosis
• steatosis
• severe hepatic enlargement
• hepatic metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• indigestion

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, and it is best kept in a cool place between 15 and 30 degrees Celsius.

Appearance

White to off-white, triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)