Medication info
Enticant Tablet 1.0 mg (Entacavir)

Enticant Tablet 1.0 mg (Entacavir)

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

MFDS item code 201400366 · Approved 2014.01.28 · Insurance code 644913660

Summary

Main use
Treatment of chronic hepatitis B virus infection in adults (16 years and older)
Who takes it
Adults · Children
Adult dose
This medicine 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., those 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: As creatinine clearance decreases in patients with renal impairment, the oral clearance of this medicine decreases. Adjust the dose as follows in patients with creatinine clearance below 50mL/min, including those receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Creatinine clearance (mL/min) Entecavir dose Entecavir dose in patients with lamivudine resistance ≥ 50 0.5 mg once daily 1 mg once daily 30 - <50 0.25 mg once daily a or 0.5 mg every 48 hours 0.5 mg once daily or 1 mg every 48 hours 10 - <30 0.15 mg once daily a or 0.5 mg every 72 hours 0.3 mg once daily a or 1 mg every 72 hours <10, hemodialysis b or CAPD 0.05 mg once daily a or 0.5 mg every 7 days 0.1 mg once daily a or 1 mg every 7 days a: For doses below 0.5mg, use of the oral solution is recommended. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session. (Pharmacokinetic characteristics in patients with renal impairment: Refer to “8. Administration to patients with renal impairment” under Precautions for Use)
Child dose
The dosage for patients aged 16 and older is specified, but there is no separate dosage mentioned for children under 16.

Ingredients

Manufacturer
JW 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 (ALT or AST)
  • histologically confirmed active disease
View approved original text

This medication is used in adult patients infected with chronic Hepatitis B virus who have active viral replication and persistently elevated serum aminotransferases (ALT or AST) or confirmed active disease through histological examination. This drug helps improve liver inflammation and suppress viral activity, aiding in the restoration of liver function. Continuous treatment helps reduce liver damage and supports recovery to a healthy liver state. Therefore, it is effective in the treatment of chronic Hepatitis B.

How to take

Adult dose

This medicine 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., those 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: As creatinine clearance decreases in patients with renal impairment, the oral clearance of this medicine decreases. Adjust the dose as follows in patients with creatinine clearance below 50mL/min, including those receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Creatinine clearance (mL/min) Entecavir dose Entecavir dose in patients with lamivudine resistance ≥ 50 0.5 mg once daily 1 mg once daily 30 - <50 0.25 mg once daily a or 0.5 mg every 48 hours 0.5 mg once daily or 1 mg every 48 hours 10 - <30 0.15 mg once daily a or 0.5 mg every 72 hours 0.3 mg once daily a or 1 mg every 72 hours <10, hemodialysis b or CAPD 0.05 mg once daily a or 0.5 mg every 7 days 0.1 mg once daily a or 1 mg every 7 days a: For doses below 0.5mg, use of the oral solution is recommended. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session. (Pharmacokinetic characteristics in patients with renal impairment: Refer to “8. Administration to patients with renal impairment” under Precautions for Use)

Child dose

The dosage for patients aged 16 and older is specified, but there is no separate dosage mentioned for children under 16.

Precautions

This medication is used for the treatment of liver diseases, and there are several important points to be cautious about during its use. First, serious liver side effects such as lactic acidosis and steatosis may occur with its use, particularly in female patients, obese patients, and those with pre-existing liver disease risk factors, and extra caution is advised. Second, sudden discontinuation of treatment can lead to a rapid worsening of Hepatitis B, so when discontinuing treatment, it is essential to regularly check and monitor liver function according to the doctor's instructions. Third, this medication is not recommended for patients co-infected with HIV and Hepatitis B, and HIV infection status must be confirmed before use. Fourth, patients with allergies to this drug or its components or with genetic conditions such as lactose intolerance should not take this medication. Fifth, patients with impaired kidney function or those receiving kidney dialysis should have dose adjustments, and liver transplant patients should also closely monitor kidney function. Sixth, taking this medication on an empty stomach increases absorption efficiency, so it is advisable not to take it with food. Seventh, side effects such as headache, fatigue, dizziness, and nausea may occur; if any abnormal symptoms appear, consult a doctor. Eighth, since this medication is primarily excreted through the kidneys, caution is needed when taken with other medications that affect kidney function, and potential interactions between this medication and others should also be considered. Ninth, during pregnancy, there is a risk to the fetus; therefore, it should only be used after consulting a doctor. For nursing mothers, it is recommended to either discontinue breastfeeding or stop the medication. Finally, special care is necessary for children, elderly patients, and patients with reduced liver or kidney function; if an overdose occurs, consult healthcare providers immediately for appropriate actions. To use this medication safely, it is crucial to adhere to the doctor's prescription and instructions and to regularly check liver and kidney status.

Side effects

  • Lactic acidosis
  • steatosis
  • liver enlargement
  • liver metabolic dysfunction
  • headache
  • fatigue
  • dizziness
  • nausea
  • diarrhea
  • dyspepsia
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  • vomiting
  • lightheadedness
  • drowsiness
  • insomnia
  • anaphylactic reactions
  • increased aminotransferases
  • alopecia
  • rash
  • upper abdominal pain
  • heartburn
  • hematuria
  • hyperglycemia
  • diabetes
  • thrombocytopenia
  • hepatic neoplasm
  • intraperitoneal hemorrhage
  • ascites
  • portal hypertension gastritis
  • gastrointestinal bleeding
  • cholangitis
  • hepatic encephalopathy
  • septal deviation
  • sepsis
  • eyelid skin disease
  • gastric angioectasia
  • chronic sinusitis
  • cold
  • itching
  • chest pain
  • constipation
  • abdominal pain
  • back pain
  • abdominal discomfort
  • runny nose
  • abdominal pain
  • bad 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 that does not allow air to pass through, with a storage temperature maintained between 15 to 30 degrees Celsius at room temperature. Proper storage will help maintain the drug's effectiveness over time and prevent deterioration.

Appearance and packaging

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets (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.