Jinyang Entacavir Tablet 1.0 mg (Entacavir)

Adult dose

Take this medicine 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 16 years of age and 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: 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 less than 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 medicine after the hemodialysis session. (Pharmacokinetic properties in patients with renal impairment: See “8. Administration to patients with renal impairment” in Precautions for use)

Child dose

The dosing for patients 16 years and older with lamivudine-resistant patients is specified separately; thus, there is no specific dosage information for children under 16 years.

This drug must be administered with extreme caution in patients with liver disease. In particular, if liver function is severely impaired, serious side effects such as lactic acidosis and fatty liver may occur, so liver function must be closely monitored. Discontinuation of this drug may lead to an acute exacerbation of hepatitis B; therefore, liver function tests should be continuously conducted for several months after stopping treatment. In patients co-infected with HIV and hepatitis B who are not receiving HIV treatment, it is advisable not to use this drug. An HIV infection test must be performed before use. Patients with hypersensitivity to this drug or its ingredients, as well as those with genetic issues such as lactose intolerance, should not be administered this drug. In patients with renal failure or those undergoing hemodialysis, dose adjustments are necessary, and liver transplant recipients should also administer with careful monitoring of kidney function. This drug contains color additive Yellow No. 5; patients allergic to this ingredient should use it cautiously. During treatment, side effects such as headache, fatigue, dizziness, nausea may occur, and if abnormal liver function test values are observed, immediate consultation with healthcare professionals is required. During pregnancy, there may be risks to the fetus; hence, it should only be used when the benefits outweigh the risks. During lactation, since this drug may be secreted into breast milk, it may be necessary to discontinue breastfeeding or the medication. Taking this drug with food may reduce its absorption, so it is advisable to take it on an empty stomach. This drug is excreted through the kidneys; therefore, when used with drugs affecting kidney function or being affected by it, careful monitoring for potential side effects is essential. In case of overdose, since there is no specific antidote, appropriate supportive care should be received based on symptoms, and some removal can be achieved through hemodialysis. This drug requires caution in specific patient groups such as children, the elderly, pregnant women, and patients with impaired liver or kidney function; the prescribed dosage and administration must be strictly followed. For storage, keep it out of reach of children, avoid direct sunlight, and store at room temperature. Syrup forms should not be diluted or mixed with other liquids.

• Hyperlipidemia
• fatty liver
• liver enlargement
• hepatic metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• indigestion

This drug may be affected by air and light; therefore, it must be stored in a tightly sealed container in a place where light does not enter. It is important to maintain the storage temperature between 15 degrees and 30 degrees.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)