Medication info
Winbarak Tablet 1 mg (Entacavir)

Winbarak Tablet 1 mg (Entacavir)

Prescription medicationTabletOral
Ingredient · strength
Entecavir›1.06mg / 1 tablet
Manufacturer / importer
Hanwha Pharmaceutical Co., Ltd.
Appearance
Pink triangular film-coated tablet
Packaging
30 tablets (10 tablets/Alu-Alu X 3)
Approval status
Active

MFDS item code 201402828 · Approved 2014.06.25 · Insurance code 651601720

Summary

Main use
Treatment of chronic hepatitis B in adults (16 years and older)
Who takes it
Adults · Children
Adult dose
Administer 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 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: 1 mg of entecavir once daily on an empty stomach 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 50 mL/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 0.5 mg, use of the syrup formulation is recommended. b : If administered on a hemodialysis day, administer this drug after the hemodialysis session.
Child dose
For patients aged 16 years and older with lamivudine resistance, a single oral dose of 1 mg of entacavir should be administered once daily on an empty stomach.

Ingredients

Manufacturer
Hanwha Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of chronic hepatitis B in adults (16 years and older)

  • Chronic hepatitis B virus infection
  • persistent elevation of serum aminotransferases (ALT or AST)
  • histologically confirmed active disease
View approved original text

This medication is used for the treatment of adults aged 16 years and older with chronic hepatitis B who have confirmed active disease, which is characterized by ongoing viral replication and persistent elevation of serum aminotransferases.

How to take

Adult dose

Administer 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 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: 1 mg of entecavir once daily on an empty stomach 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 50 mL/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 0.5 mg, use of the syrup formulation is recommended. b : If administered on a hemodialysis day, administer this drug after the hemodialysis session.

Child dose

For patients aged 16 years and older with lamivudine resistance, a single oral dose of 1 mg of entacavir should be administered once daily on an empty stomach.

Precautions

Caution is required when using this medication in patients with liver disease. Particularly, women may experience severe hepatic enlargement, including steatosis and fatty liver, so patients with poor liver function must consult a physician before using this medication. Abrupt discontinuation of this medication may lead to a rapid deterioration of hepatitis B, hence treatment should be discontinued under a physician's guidance with periodic monitoring of liver function. In patients co-infected with HIV and hepatitis B who are not receiving HIV treatment, this medication is not recommended and testing for HIV infection is necessary. Patients with hypersensitivity to this medication or those with genetic lactose intolerance should not take it, and patients with reduced kidney function require dose adjustment. Patients who have undergone liver transplantation must closely monitor kidney function before and during treatment with this medication. During the use of this medication, patients may experience symptoms such as headache, fatigue, dizziness, and nausea; any unusual symptoms should be reported to healthcare providers. Taking this medication with food may reduce its absorption; therefore, it is recommended to take it on an empty stomach as much as possible. Women who are pregnant or breastfeeding should carefully consider the impact on the fetus or newborn when using this medication, and if breastfeeding, it is recommended to discontinue breastfeeding or the medication. Patients with renal insufficiency should take this medication after hemodialysis, and the dosage should be adjusted according to kidney function. In cases of overdose, there is no specific antidote, and supportive treatment should be provided according to the symptoms. Children and elderly patients can also use this medication, but dosage adjustment and caution are necessary according to kidney function status. This medication can interact with other drugs, so it is important to consult healthcare providers, especially when taking drugs that affect kidney function. Finally, this medication should be stored out of reach of children, protected from direct sunlight, and kept at specified temperatures.

Side effects

lactate, fatty liver, enlargement of the liver, hepatic metabolic dysfunction, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, lightheadedness, drowsiness, insomnia, anaphylactic reaction, increase in amino transferases, hair loss, rash, epigastric pain, heartburn, pruritus, chest pain, constipation, abdominal pain, back pain, abdominal discomfort, runny nose, hematuria, thrombocytopenia, hyperglycemia, diabetes, liver tumor, intra-abdominal bleeding, ascites, portal hypertension-related gastric disease, gastrointestinal hemorrhage, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disease, gastric vascular tumor, chronic sinusitis, abdominal pain, rash, unpleasant taste, neutropenia

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to prevent air and moisture from entering, and it is recommended to store it at room temperature between 15 and 30 degrees Celsius. This helps maintain the efficacy of the medication and prevent degradation.

Appearance and packaging

Appearance

Pink triangular film-coated tablet

Package unit

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

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.