Medication info

Entacavir Tablet 1mg (Entacavir)

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

MFDS item code 201405525 · Approved 2014.11.26

This product's status changed to Expired on 2024.11.26. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of chronic hepatitis B virus infection in adults (16 years and older)
Who takes it
Adults
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 entecavir 0.5mg orally once daily. Patients aged 16 years and older who are lamivudine-resistant, i.e., who have experienced persistent hepatitis B virus replication despite lamivudine treatment or 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 drug decreases as creatinine clearance decreases. Adjust the dose as follows in patients with creatinine clearance below 50mL/min, including patients receiving hemodialysis or peritoneal dialysis (CAPD). Creatinine clearance (mL/min) ≥ 50: Entecavir dose 0.5 mg once daily / Entecavir dose in lamivudine-resistant patients 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 lamivudine-resistant patients 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 lamivudine-resistant patients 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 lamivudine-resistant patients 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.

Ingredients

Manufacturer
KMS Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Active viral replication
  • persistent elevation of serum aminotransferases
  • histologically confirmed active disease
View approved original text

This medication is used for adult patients over 16 years of age infected with chronic hepatitis B virus, in cases of active viral replication accompanied by persistent elevation of serum aminotransferases (ALT or AST) or when active disease is histologically confirmed, for viral suppression and improvement of liver function.

How to take

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 entecavir 0.5mg orally once daily. Patients aged 16 years and older who are lamivudine-resistant, i.e., who have experienced persistent hepatitis B virus replication despite lamivudine treatment or 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 drug decreases as creatinine clearance decreases. Adjust the dose as follows in patients with creatinine clearance below 50mL/min, including patients receiving hemodialysis or peritoneal dialysis (CAPD). Creatinine clearance (mL/min) ≥ 50: Entecavir dose 0.5 mg once daily / Entecavir dose in lamivudine-resistant patients 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 lamivudine-resistant patients 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 lamivudine-resistant patients 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 lamivudine-resistant patients 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.

Precautions

This medication is used for the treatment of liver disease and is prescribed particularly for chronic hepatitis B patients. Caution is needed when using this drug because there is a risk of severe liver problems such as lactic acidosis and fatty liver disease, especially in female patients and those who are obese. Patients with impaired liver function should often check the health status of their liver during the use of this medication, and if liver toxicity is suspected, they should stop taking the drug. Additionally, abruptly stopping this medication may lead to a rapid worsening of hepatitis B, so regular liver function tests should be performed when discontinuing treatment. Patients who are co-infected with HIV and hepatitis B should undergo HIV testing and consult their physician, as this medication is not suitable for HIV treatment. Do not administer this drug to patients with allergies to it or those with lactose intolerance. Patients with decreased kidney function require dosage adjustments, and those undergoing hemodialysis should take the medication after dialysis. Liver transplant recipients must closely monitor their kidney function when using this medication in combination with immunosuppressants. It is recommended to take this medication on an empty stomach, as food may reduce absorption. Side effects may include headache, fatigue, dizziness, nausea, and it is important to consult a healthcare provider if severe adverse reactions occur. During pregnancy, this medication should only be used when absolutely necessary, taking into account the risks to the fetus, and if breastfeeding, discussion with a doctor regarding discontinuation of breastfeeding and medication use is required. Use in children is permitted only for those aged 2 years and older, as safety and efficacy have not been established in children under 2 years of age. Since this medication is primarily excreted through the kidneys, special caution should be taken in patients with impaired kidney function. In case of overdose, immediate medical attention should be sought, and some of the drug may be removed through hemodialysis. This medication should be stored out of the reach of children, away from direct sunlight, and at room temperature.

Side effects

Liver cirrhosis, steatosis, severe liver enlargement, liver metabolic dysfunction, headache, fatigue, dizziness, nausea, diarrhea, indigestion, vomiting, vertigo, drowsiness, insomnia, anaphylactic reactions, increase in aminotransferases, hair loss, rash, upper abdominal pain, heartburn, itching, cold, cough, chest pain, constipation, abdominal pain, low back pain, abdominal discomfort, runny nose, intra-abdominal bleeding, ascites, portal hypertension-related gastric diseases, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disorders, gastric hemangioma, 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 sealed container to prevent air from entering and kept in a cool place between 15 to 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Pink triangular film-coated tablet

Package unit

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

Same-ingredient medicines

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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.