Medication info
Jinyang Entacavir Tablet 0.5 mg (Entacavir)

Jinyang Entacavir Tablet 0.5 mg (Entacavir)

Prescription medicationTabletOral
Ingredient · strength
Entecavir›0.53mg / 1 tablet
Manufacturer / importer
Jinyang Pharmaceutical Co., Ltd.
Appearance
White triangular film-coated tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201310620 · Approved 2013.12.11 · Insurance code 650303110

Summary

Main use
Treatment of chronic hepatitis B virus infection
Who takes it
Adults · Children
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). The dose is 0.5mg of entecavir orally once daily. Patients aged 16 years or older with lamivudine resistance, i.e., those who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or have lamivudine-resistant mutations: 1mg of entecavir once daily on an empty stomach Patients with renal impairment: Creatinine clearance ≥ 50 mL/min: 0.5 mg once daily; entecavir dose in patients with lamivudine resistance: 1 mg once daily Creatinine clearance 30 - <50 mL/min: 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: 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: 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 less than 0.5mg. b: If administered on a hemodialysis day, administer this drug after the hemodialysis session.
Child dose
Dosage instructions are mentioned only for patients aged 16 years and older with lamivudine-resistant strains, and there are no separate dosing guidelines for children under 16 years.

Ingredients

Manufacturer
Jinyang Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of chronic hepatitis B virus infection

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

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

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). The dose is 0.5mg of entecavir orally once daily. Patients aged 16 years or older with lamivudine resistance, i.e., those who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or have lamivudine-resistant mutations: 1mg of entecavir once daily on an empty stomach Patients with renal impairment: Creatinine clearance ≥ 50 mL/min: 0.5 mg once daily; entecavir dose in patients with lamivudine resistance: 1 mg once daily Creatinine clearance 30 - <50 mL/min: 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: 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: 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 less than 0.5mg. b: If administered on a hemodialysis day, administer this drug after the hemodialysis session.

Child dose

Dosage instructions are mentioned only for patients aged 16 years and older with lamivudine-resistant strains, and there are no separate dosing guidelines for children under 16 years.

Precautions

This medication may affect liver function, thus caution is particularly required for patients with liver disease or impaired liver function. Discontinuation of this medication can worsen hepatitis, so it should be tapered off according to the physician's instructions. The use of this medication is not recommended for patients co-infected with HIV and hepatitis B who are not receiving HIV treatment. Patients with hypersensitivity to this medication or specific genetic disorders such as lactose intolerance should not take it. Patients with impaired renal function, especially those receiving hemodialysis or peritoneal dialysis, may require dose adjustment. Patients who have undergone liver transplantation should closely monitor renal function before and during treatment with this medication. This medication may cause side effects such as headache, fatigue, dizziness, and nausea, so consult a healthcare professional if symptoms are severe. Periodic liver function tests should be performed during treatment, and any abnormal elevation in liver enzymes should be communicated to a healthcare professional immediately. During pregnancy, this medication should only be used when necessary, considering the risk to the fetus, and nursing should be stopped or the medication discontinued while breastfeeding. Taking this medication with food may reduce absorption, so it is recommended to take it on an empty stomach. This medication is excreted through the kidneys, so care should be taken when used with other medications that may affect renal function. Overdosage may result in toxic reactions, so the prescribed dosage must be strictly followed. Safety and efficacy may vary in specific populations such as children, the elderly, and pregnant women; thus, special caution is required when administering to these populations. Store this medication out of reach of children, away from direct sunlight and at room temperature.

Side effects

Hypoglycemia, steatosis, hepatomegaly, impaired hepatic metabolic function, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, vertigo, drowsiness, insomnia, anaphylactic reaction, increased aminotransferases, hair loss, rash, epigastric pain, heartburn, pruritus, chest pain, constipation, abdominal pain, lumbar pain, abdominal discomfort, rhinorrhea, hematuria, thrombocytopenia, hyperglycemia, diabetes, hepatic neoplasm, intra-abdominal hemorrhage, ascites, portal hypertension-related complications, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disorder, gastric angiohyperplasia, chronic sinusitis, abdominal pain, rash, unpleasant taste, neutropenia

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be photosensitive, so it should be stored in a tightly closed container that is not exposed to light. It is advisable to maintain the storage temperature between 15 and 30 degrees Celsius to ensure the medication remains effective.

Appearance and packaging

Appearance

White 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.

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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.