Medication info
Enfed Tablet 1mg (entecavir)

Enfed Tablet 1mg (entecavir)

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

MFDS item code 201206904 · Approved 2012.09.24 · Insurance code 643903280

Summary

Main use
Treatment of chronic hepatitis B virus infection
Who takes it
Adults
Adult dose
This medicine should be taken orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Take 0.5mg of entecavir orally once daily. Patients aged 16 years or older with lamivudine resistance, that is, patients who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: Take 1mg of entecavir once daily on an empty stomach. Patients with renal failure: As creatinine clearance decreases in patients with renal failure, the oral clearance of this medicine 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 ≥ 50 mL/min: entecavir dose 0.5 mg once daily; entecavir dose in patients with lamivudine resistance 1 mg once daily Creatinine clearance 30 - <50 mL/min: 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 10 - <30 mL/min: 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 <10 mL/min, 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: Use of the oral solution is recommended for doses below 0.5mg. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session.

Ingredients

Manufacturer
Sam-il Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of chronic hepatitis B virus infection

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

This medication is used in adult patients aged 16 years and older with confirmed chronic hepatitis B virus infection, when active viral replication and persistent elevation of serum aminotransferases (ALT or AST) or histological evidence are present. It helps to suppress the progression of chronic hepatitis B and improves liver function.

How to take

Adult dose

This medicine should be taken orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Take 0.5mg of entecavir orally once daily. Patients aged 16 years or older with lamivudine resistance, that is, patients who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: Take 1mg of entecavir once daily on an empty stomach. Patients with renal failure: As creatinine clearance decreases in patients with renal failure, the oral clearance of this medicine 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 ≥ 50 mL/min: entecavir dose 0.5 mg once daily; entecavir dose in patients with lamivudine resistance 1 mg once daily Creatinine clearance 30 - <50 mL/min: 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 10 - <30 mL/min: 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 <10 mL/min, 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: Use of the oral solution is recommended for doses below 0.5mg. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session.

Precautions

This drug should be used with caution in patients with weak liver function or those at risk of liver disease. Serious liver problems, including lactic acidosis and fatty liver, can occur, especially in women, therefore regular liver function tests should be carried out as directed by a physician. Stopping this medication suddenly can lead to rapid deterioration of hepatitis B, so if treatment is to stop, a doctor should be consulted and liver condition should be continuously monitored. Patients who are infected with HIV but not treated should be tested for HIV before using this product, which is not recommended for HIV treatment. Patients with allergies to this drug or its ingredients or with genetic issues such as lactose intolerance should not use it. Dose adjustment is needed for patients with decreased kidney function or undergoing hemodialysis, and those who have undergone liver transplantation should carefully monitor kidney function and the effects of this medication. This medication may cause side effects such as headache, fatigue, dizziness, nausea, and liver function abnormalities should be reported to a physician immediately. It is better to take on an empty stomach as absorption may decrease when taken with food. During pregnancy, it should only be used when absolutely necessary considering risks to the fetus, and during breastfeeding, nursing should be discontinued or consult with a physician. Special populations such as children, the elderly, and patients with renal insufficiency need dose adjustments and careful attention. In case of overdose, there is no specific antidote, so appropriate treatment should be provided according to symptoms, and some of the drug may be eliminated by hemodialysis. This drug may have interactions when used with other kidney-excreting medications, so it is essential to discuss with a doctor or pharmacist about any other medications being taken. Regular liver function and blood tests to check for adverse reactions during treatment are important. This medication should be stored out of the reach of children, away from direct sunlight, and at room temperature.

Side effects

  • Liver dysfunction
  • fatty liver
  • hepatomegaly
  • impaired liver metabolism
  • headache
  • fatigue
  • dizziness
  • nausea
  • diarrhea
  • dyspepsia
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  • vomiting
  • lightheadedness
  • drowsiness
  • insomnia
  • anaphylactic reaction
  • increase in aminotransferases
  • hair loss
  • rash
  • abdominal pain
  • heartburn
  • itching
  • cold
  • cough
  • chest pain
  • constipation
  • abdominal pain
  • lower back pain
  • abdominal discomfort
  • nasal discharge
  • hematuria
  • thrombocytopenia
  • hyperglycemia
  • diabetes
  • liver tumor
  • intra-abdominal bleeding
  • ascites
  • portal hypertension gastric disease
  • gastrointestinal bleeding
  • cholangitis
  • hepatic encephalopathy
  • septal deviation
  • sepsis
  • eyelid skin disorders
  • 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 sealed airtight container, preferably at room temperature between 15°C and 30°C. Proper storage helps maintain the efficacy of the medication.

Appearance and packaging

Appearance

Pink triangular film-coated tablet

Package unit

10 tablets/blister 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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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.