Medication info

LITE Entacavir Tablet 0.5 mg (Entacavir)

Prescription medicationTabletOralExpired
Ingredient · strength
Entecavir›0.53mg / 1 tablet
Manufacturer / importer
LITE Pharmatech Co., Ltd.
Appearance
White to grayish white triangular shaped film-coated tablets
Packaging
30 tablets/box [(10 tablets/PTP x 3)]
Approval status
Expired

MFDS item code 201908106 · Approved 2019.11.27

This product's status changed to Expired on 2024.11.27. 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
Who takes it
Adults · Children
Adult dose
This medication 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 medication decreases as creatinine clearance decreases. Adjust the dose as follows in patients with creatinine clearance below 50mL/min, including patients 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 less than 0.5mg, use of the syrup formulation is recommended. b: If administered on a hemodialysis day, administer this medication after the hemodialysis session.
Child dose
The adult dosage is applicable to patients aged 16 years and older, and there are no specific dosing instructions for children.

Ingredients

Manufacturer
LITE Pharmatech Co., Ltd.

Efficacy & effects

Treatment of chronic hepatitis B virus infection

  • Active viral replication
  • persistent elevation of serum amino transferases (ALT or AST)
  • histologically active disease
View approved original text

This medication is used for the treatment of chronic hepatitis B patients aged 16 years and older where active viral replication has been confirmed, with persistent elevation of serum amino transferases (ALT or AST) or histologically active disease.

How to take

Adult dose

This medication 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 medication decreases as creatinine clearance decreases. Adjust the dose as follows in patients with creatinine clearance below 50mL/min, including patients 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 less than 0.5mg, use of the syrup formulation is recommended. b: If administered on a hemodialysis day, administer this medication after the hemodialysis session.

Child dose

The adult dosage is applicable to patients aged 16 years and older, and there are no specific dosing instructions for children.

Precautions

This medication is used for the treatment of liver disease, and there are several precautions to consider when using it. First, serious liver issues such as lactic acidosis and steatosis may occur, particularly in women, when this medication is used alone or in combination with other specific antiviral agents. Second, discontinuing this medication abruptly may cause a rapid deterioration of hepatitis B, so liver function should be closely monitored for several months after stopping treatment. Third, this medication is not recommended for patients with HIV infection who have not yet received treatment, and an HIV test is required before using it. Fourth, it should not be used if there is an allergy to this medication or its components, or in cases of specific hereditary lactose metabolism disorders. Fifth, dosage adjustments are necessary for patients with impaired kidney function or those receiving dialysis, and kidney function should be carefully monitored in liver transplant patients. Sixth, during the use of this medication, side effects such as headache, fatigue, dizziness, and nausea may occur, and treatment may need to be temporarily halted if liver function test values increase. Seventh, it is advisable to take this medication on an empty stomach as food may reduce drug absorption. Eighth, since this medication is primarily excreted through the kidneys, caution is needed when taking it in conjunction with other medications that may affect kidney function. Ninth, during pregnancy, there may be risks to the fetus, so it is essential to consult a physician before use, and during breastfeeding, consideration should be given to stopping breastfeeding or ending treatment. Finally, this medication can be used in children, but it is not recommended for children under 2 years of age as safety and efficacy have not been established. When using this medication, it is very important to have regular liver and kidney function tests and to take it in accordance with the physician's instructions.

Side effects

  • Lactic acidosis
  • steatosis
  • hepatomegaly
  • hepatic metabolic dysfunction
  • headache
  • fatigue
  • dizziness
  • nausea
  • diarrhea
  • dyspepsia
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  • vomiting
  • vertigo
  • drowsiness
  • insomnia
  • anaphylactic reaction
  • increase in aminotransferases
  • hair loss
  • rash
  • upper abdominal pain
  • heartburn
  • cold
  • cough
  • itching
  • chest pain
  • constipation
  • abdominal pain
  • back pain
  • abdominal discomfort
  • rhinorrhea
  • intra-abdominal hemorrhage
  • ascites
  • portal hypertension-related 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 exposure, and it is recommended to keep it in a cool place at a temperature between 15 and 30 degrees Celsius. Proper storage will maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

White to grayish white triangular shaped film-coated tablets

Package unit

30 tablets/box [(10 tablets/PTP 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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.