Baqir 0.5 mg Tablets (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 entecavir 0.5mg orally once daily. Patients aged 16 years and 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: Administer entecavir 1mg 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 below 50mL/min, including those receiving hemodialysis or 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 below 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: Refer to “8. Administration to Patients with Renal Impairment” in Precautions for Use)

Child dose

Since there are specific dosing instructions for patients aged 16 years and older with lamivudine-resistant strains, there are no separate dosing methods for children under 16 years.

This medication may cause serious liver issues such as lactic acidosis and steatosis in patients with liver disease, especially in women and those who are obese, so caution is required. The risk of lactic acidosis is higher in patients with poor liver function, and if symptoms occur during treatment, the medication should be discontinued. Abrupt discontinuation of this medication can result in a rapid worsening of hepatitis B, so liver function needs to be carefully monitored for several months after stopping the medication. In HIV-infected patients who are untreated, use of this medication may lead to resistance against HIV treatments, so HIV testing must be performed and this medication is not recommended for HIV treatment purposes. Patients with allergies to this medication or its components, or those with genetic issues such as lactose intolerance, should not use this medication. Patients with reduced kidney function or those undergoing dialysis require dose adjustments, and liver transplant patients should be carefully monitored for kidney function. Common side effects may include headache, fatigue, dizziness, nausea, but these are usually mild; serious side effects should prompt consultation with healthcare professionals. During treatment, regular liver function tests are necessary, and if liver enzyme levels rise sharply, healthcare professionals should be informed immediately. This medication should be taken on an empty stomach as food may reduce its absorption. During pregnancy, it must be administered only after consulting a physician due to potential risks to the fetus, and breastfeeding mothers should either discontinue breastfeeding or stop taking this medication. It can also be used in pediatric patients, but safety and effectiveness in children under 2 years of age have not been established. Elderly patients are more likely to have diminished kidney function, so dosage adjustments and kidney function tests are necessary. There is no specific antidote in case of overdose, so symptomatic treatment and observation are necessary; some removal can be done through dialysis. Since this medication is excreted through the kidneys, it is important to monitor for side effects when taken with medications that affect kidney function or compete for excretion. When storing, keep it out of reach of children, avoid direct sunlight, and store at room temperature. Do not transfer to another container, dilute the syrup, or mix with other liquids as this may compromise quality.

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

This medication should be stored in a tightly sealed container to prevent air and moisture intrusion. Additionally, it is important to store it in a cool place between 15 and 30 degrees Celsius to maintain its effectiveness.

Appearance

White triangular film-coated tablet

Package unit

30 tablets (10 tablets x 3) / Alu-Alu