Medication info

Jungheon Entacavir Hydrate Tablet 0.5 mg

Prescription medicationTabletOralExpired
Ingredient · strength
Entecavir Hydrate›0.53mg / 1 tablet
Manufacturer / importer
Jungheon Pharmaceutical Co., Ltd.
Appearance
White to light gray film-coated triangular tablets
Packaging
30 tablets - 10 tablets/Alu-Alu [PTP x 3]
Approval status
Expired

MFDS item code 201903006 · Approved 2019.05.09

This product's status changed to Expired on 2024.05.09. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of chronic hepatitis B in adults with confirmed active viral replication
Who takes it
Adults
Adult dose
Administer this medicine 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 with lamivudine resistance, that is, patients aged 16 years or older who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or have lamivudine-resistant variants: Administer 1mg of entecavir orally once daily on an empty stomach. In patients with renal impairment, the oral clearance of this medicine 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 ≥ 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, 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 syrup formulation is recommended for doses below 0.5mg. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session.

Ingredients

Manufacturer
Jungheon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of chronic hepatitis B in adults with confirmed active viral replication

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

This medication is used for adult chronic hepatitis B patients where active viral replication has been confirmed, and serum amino transferase (ALT or AST) levels are persistently elevated or histologically active disease has been confirmed. This drug helps reduce liver damage and improve liver function by inhibiting viral proliferation. Therefore, it is effectively used for the treatment of chronic hepatitis B.

How to take

Adult dose

Administer this medicine 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 with lamivudine resistance, that is, patients aged 16 years or older who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or have lamivudine-resistant variants: Administer 1mg of entecavir orally once daily on an empty stomach. In patients with renal impairment, the oral clearance of this medicine 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 ≥ 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, 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 syrup formulation is recommended for doses below 0.5mg. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session.

Precautions

This medication is used to treat liver diseases, specifically prescribed for chronic hepatitis B patients. When using this drug, serious liver side effects such as lactic acidosis and steatosis may occur, hence patients with compromised liver function, women, and obese patients should be more cautious. If symptoms of liver dysfunction or lactic acidosis appear, the use of this medication should be immediately discontinued, and consultation with a physician is necessary. Abrupt discontinuation of this medication may lead to rapid deterioration of hepatitis B, so treatment should be stopped only under a doctor's direction. Patients with both HIV and hepatitis B should preferably not use this drug alone, and HIV infection should be screened beforehand. Patients with lactose intolerance or specific genetic metabolic disorders should not take this medication. Patients with impaired kidney function, especially those undergoing hemodialysis or peritoneal dialysis, require dosage adjustments, and kidney function should be closely monitored in patients who have undergone liver transplant surgery. During treatment with this drug, symptoms such as headaches, fatigue, dizziness, nausea, etc., may occur, and if they are severe, patients should inform their physician. Periodic liver function tests are essential, and if there is a significant elevation in liver enzyme levels in blood tests, treatment should be reassessed. Pregnant or nursing women should consult with a physician before using this medication, as its effects on the fetus or newborn are not clearly established. This drug can be used for children aged 2 years and older, and safety and efficacy have not been established in those under 2 years of age. Since this medication is excreted through the kidneys, dosage adjustments and renal function tests are essential for patients with impaired kidney function. Taking this medication with food may reduce its absorption, so it is advisable to take it on an empty stomach. When combined with other medications, there may be interactions with drugs that affect kidney function, so patients must inform their doctor of any medications they are taking. In case of overdose, there is no specific antidote, so it is crucial to receive appropriate treatment based on symptoms. This drug should be stored out of reach of children, protected from direct sunlight, and kept at room temperature.

Side effects

Hyperlipidemia, steatosis, severe liver enlargement, impaired liver metabolic function, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, lightheadedness, drowsiness, insomnia, anaphylactic reaction, increase in aminotransferases, hair loss, rash, upper abdominal pain, heartburn, chest pain, cold, itching, constipation, abdominal pain, lower back pain, abdominal discomfort, runny nose, intra-abdominal bleeding, ascites, portal hypertension-related gastric disorders, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disorders, gastric angiomatosis, 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 exposure. It is advisable to maintain storage temperatures between 15 and 30 degrees Celsius. This will help preserve the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

White to light gray film-coated triangular tablets

Package unit

30 tablets - 10 tablets/Alu-Alu [PTP x 3]

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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.