Winbarak Tablet 0.5 mg (Entecavir)

Adult dose

This drug should be administered orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Administer 0.5mg of entecavir orally once daily. Patients aged 16 years and older with lamivudine resistance, i.e., patients who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: 1mg of entecavir 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. Adjust the dose as follows in patients with creatinine clearance less than 50mL/min, including patients receiving hemodialysis or peritoneal dialysis (CAPD). 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 drug after the hemodialysis session. (Pharmacokinetic properties in patients with renal impairment: See “8. Administration to patients with renal impairment” in Precautions for Use)

This drug should be used cautiously in patients with liver dysfunction. Serious hepatic conditions such as lactic acidosis and steatosis may occur with the use of nucleoside analogs, especially in female patients and those who are obese. Discontinuation of this drug can lead to a sudden worsening of hepatitis B, so liver function should be closely monitored for several months after stopping treatment. This drug is not recommended for patients who are not receiving treatment for HIV infection, and an HIV test prior to use is important. Patients with known allergies to this drug or its components, or those with lactose intolerance should not take this medication. Dose adjustments may be necessary for patients with impaired renal function or those undergoing dialysis. Patients who have undergone liver transplantation should carefully monitor kidney function when used in combination with immunosuppressants that may affect renal function. The most common side effects of this drug include headache, fatigue, dizziness, nausea, etc. Treatment should be halted immediately if abnormal liver function test results occur. Taking the medication with food may reduce absorption, so it is advisable to take it on an empty stomach. During pregnancy, it should only be used when absolutely necessary, considering the risk to the fetus, and during breastfeeding, it is advised to either stop breastfeeding or discontinue the medication due to possible excretion in breast milk. In case of overdose, there is no specific antidote, so symptomatic and supportive treatment should be provided, and some drugs may be removed via dialysis. This medication is excreted by the kidneys, so using it in combination with other drugs that may affect renal function may increase side effects, and consulting with healthcare professionals is necessary. Children and elderly patients can also use this drug, but dose adjustments may be required based on renal function status. Finally, this medication should be kept out of reach of children and stored at room temperature, protected from direct sunlight.

Hepatic steatosis, fatty liver, hepatomegaly, impaired liver metabolism, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, lightheadedness, drowsiness, insomnia, anaphylactic reactions, increase in aminotransferases, hair loss, rash, upper abdominal pain, heartburn, chest pain, cold, cough, itching, constipation, abdominal pain, back pain, abdominal discomfort, runny nose, intra-abdominal bleeding, ascites, portal hypertension-related gastric disease, gastrointestinal hemorrhage, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disease, gastric angiomatosis, chronic sinusitis, abdominal pain, rash, unpleasant taste, neutropenia

This drug should be stored in a tightly closed container to prevent air ingress and is best kept at a temperature between 15 to 30 degrees Celsius. This storage will help maintain the drug's efficacy.

Appearance

White to grayish triangular-shaped film-coated tablet

Package unit

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