Baraclude 0.5 mg (Entecavir)

Adult dose

Administer this drug orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Administer entecavir 0.5 mg orally once daily. Patients aged 16 years or older who are resistant to lamivudine, that is, those who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or have lamivudine-resistant mutations: entecavir 1 mg once daily on an empty stomach Patients with renal impairment: In patients with renal impairment, the oral clearance of this drug decreases as creatinine clearance decreases. For patients with creatinine clearance below 50 mL/min, including those receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), adjust the dose as follows. Creatinine clearance (mL/min) Entecavir dose Entecavir dose in patients resistant to lamivudine ≥ 50 0.5 mg once daily 1 mg once daily 30 - <50 0.25 mg once daily a or 0.5 mg every 48 hours 0.5 mg once daily or 1 mg every 48 hours 10 - <30 0.15 mg once daily a or 0.5 mg every 72 hours 0.3 mg once daily a or 1 mg every 72 hours <10, hemodialysis b or CAPD 0.05 mg once daily a or 0.5 mg every 7 days 0.1 mg once daily a or 1 mg every 7 days a: For doses below 0.5 mg, use of the syrup formulation is recommended. b: If administered on a hemodialysis day, administer this drug 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

For patients resistant to lamivudine or patients aged 16 years and older, 1 mg of entecavir is administered orally once daily on an empty stomach.

This medication may cause serious side effects such as lactic acidosis and steatosis in patients with impaired liver function; therefore, patients with a risk of liver disease should use it with caution. Abrupt discontinuation of this drug may lead to a severe exacerbation of hepatitis B; hence, when stopping treatment, liver function and viral status should be carefully monitored according to a physician's instructions. This medication is not recommended for patients with co-infection of HIV and hepatitis B who are not receiving HIV treatment, and testing for HIV infection should be conducted before use. Patients with allergies to this drug or its components or those with genetic issues such as lactose intolerance should not take this medication. Patients with decreased renal function or those undergoing dialysis need dose adjustment of this medication, and liver transplant patients should use it with close monitoring of renal function. Common side effects may include headache, fatigue, dizziness, nausea, and during treatment, liver function test values can increase abnormally, in which case the physician should be consulted immediately. Pregnant women should carefully consider the risks and benefits of this drug regarding their fetus, and breastfeeding women should discontinue breastfeeding or the medication, as it may be secreted in breast milk. Taking this medication with food may reduce absorption; therefore, it is advisable to take it on an empty stomach. As this drug is primarily excreted by the kidneys, close monitoring for adverse reactions is essential when taken with other medications that may affect renal function. There are no specific antidotes for overdose; hence, if symptoms occur, appropriate treatment should be sought immediately, and some removal can occur via hemodialysis. Special patient groups such as children, the elderly, and pregnant women require careful dose adjustments; particularly, the safety and efficacy are not established for children under the age of 2. This medication should be stored out of the reach of children, avoid direct sunlight, and kept at room temperature.

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

This medication should be stored in a tightly sealed container to prevent air exposure and kept at room temperature between 15 to 30 degrees Celsius. Proper storage maintains the drug's effectiveness over time.

Appearance

White to grayish-white tablet, triangular-shaped, film-coated

Package unit

10 tablets/blister x 3