Barod Tablet 1 mg (Entecavir)

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 0.5 mg of entecavir orally once daily. Patients with lamivudine resistance, that is, patients aged 16 years or older 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 those receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Creatinine clearance (mL/min) ≥ 50: Entecavir dose 0.5 mg once daily, entecavir dose in 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 in 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 in 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 in patients with lamivudine resistance 0.1 mg a once daily or 1 mg every 7 days a: For doses below 0.5 mg, the syrup formulation is recommended. b: If administered on a hemodialysis day, this medicine should be administered 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

No specific dosing information for those under 16 years old.

This medication may cause serious liver diseases, such as lactic acidosis and fatty liver, in patients with severely impaired liver function; therefore, it should be used with extreme caution in patients at risk of liver disease. Discontinuation of this medication may lead to a rapid deterioration of hepatitis B, thus liver function should be closely monitored for several months even after treatment is stopped. In patients co-infected with HIV and hepatitis B who are not receiving HIV treatment, the use of this medication is not recommended, and HIV infection status must be confirmed prior to treatment. This medication should not be used in patients who are hypersensitive to it or have genetic metabolic disorders such as lactose intolerance. Patients with reduced kidney function or those undergoing hemodialysis should adjust the dosage of this medication, and liver transplant patients should carefully monitor kidney function. This medication contains a dye called Yellow No. 5, and should be used cautiously in patients who have allergic reactions to this ingredient. During treatment, side effects such as headache, fatigue, dizziness, nausea, etc. may occur, so any unusual symptoms should be reported to healthcare providers. Taking this medication with food may reduce drug absorption, so it is advisable to take it on an empty stomach whenever possible. This medication is primarily excreted through the kidneys; therefore, when used with other medications that affect kidney function, the possibility of side effects should be carefully monitored. During pregnancy, this medication should be used only after carefully considering the risks to the fetus and the benefits of the treatment; if breastfeeding, it may be necessary to discontinue breastfeeding or the medication due to excretion into breast milk. In children, use is approved only for those aged 2 years and older, and safety and efficacy have not been established for those under 2 years. In the elderly, the concentration of this medication in the body may increase due to reduced kidney function, necessitating dosage adjustment and monitoring of kidney function. In case of overdose, standard supportive treatment is implemented, and hemodialysis may be considered if necessary, as some can be removed through dialysis. In carcinogenicity studies, tumor formation was reported in some animals; however, the relevance to humans is uncertain. This medication should be kept out of the reach of children, stored away from direct sunlight, and kept at room temperature. Additionally, syrup formulations should not be mixed with other solvents and must be used within the expiry date after opening.

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

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

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)